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Altura™
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Altura™
Product catalog summary
Product Description
The Altura™ Endograft System includes two bilateral aortic endografts and two iliac endografts, each pre-loaded in a 14 F delivery catheter. These are inserted into the femoral artery using a guidewire and fluoroscopic guidance. The aortic endografts are placed in the abdominal aorta below the renal arteries, while the iliac endografts are positioned in the intended sealing zone. Balloon catheters are used for dilation, and a completion aortogram checks positioning and endoleaks.
The Altura™ Endograft System includes two bilateral aortic endografts and two iliac endografts, each pre-loaded in a 14 F delivery catheter. These are inserted into the femoral artery using a guidewire and fluoroscopic guidance. The aortic endografts are placed in the abdominal aorta below the renal arteries, while the iliac endografts are positioned in the intended sealing zone. Balloon catheters are used for dilation, and a completion aortogram checks positioning and endoleaks.
Device Components
The endografts consist of a braided nitinol wire stent and a polyester graft. The aortic endograft features a suprarenal fixation segment and terminates in the distal aorta. The iliac endograft connects to the aortic endograft and comes in three sizes. Delivery catheters are single-use and deploy endografts in a specific sequence.
The endografts consist of a braided nitinol wire stent and a polyester graft. The aortic endograft features a suprarenal fixation segment and terminates in the distal aorta. The iliac endograft connects to the aortic endograft and comes in three sizes. Delivery catheters are single-use and deploy endografts in a specific sequence.
Indications for Use
The system is intended for patients with abdominal aortic and/or aorto-iliac aneurysms suitable for endovascular repair, requiring specific vascular morphology and access conditions.
The system is intended for patients with abdominal aortic and/or aorto-iliac aneurysms suitable for endovascular repair, requiring specific vascular morphology and access conditions.
Contraindications
Contraindications include systemic infections, known sensitivities to device materials, and certain anatomical or physiological conditions.
Contraindications include systemic infections, known sensitivities to device materials, and certain anatomical or physiological conditions.
Warnings and Precautions
Proper training and adherence to instructions are critical. The system should only be used by trained professionals, with a vascular surgery team available. Patient selection requires specific anatomical measurements and imaging. The system is not recommended for patients with certain conditions or anatomical limitations.
Proper training and adherence to instructions are critical. The system should only be used by trained professionals, with a vascular surgery team available. Patient selection requires specific anatomical measurements and imaging. The system is not recommended for patients with certain conditions or anatomical limitations.
Pre-Procedure Measurement Techniques and Imaging
Accurate imaging, preferably contrast-enhanced spiral CTA with 3-D reconstruction, is essential for assessing patient anatomy and ensuring proper device sizing and selection.
Accurate imaging, preferably contrast-enhanced spiral CTA with 3-D reconstruction, is essential for assessing patient anatomy and ensuring proper device sizing and selection.
Device Selection
Strict adherence to the sizing guide is recommended to avoid complications such as endoleak or device migration.
Strict adherence to the sizing guide is recommended to avoid complications such as endoleak or device migration.
Implant Procedure
Proper procedural imaging and systemic anticoagulation are required. Care should be taken to minimize handling of the device to prevent contamination and ensure accurate placement.
Proper procedural imaging and systemic anticoagulation are required. Care should be taken to minimize handling of the device to prevent contamination and ensure accurate placement.
Specifications and Procedures
The document outlines procedures for implanting the Altura Endograft System, emphasizing positioning and alignment to ensure a proper seal and avoid complications like misalignment, endoleak, or vessel damage. It advises against fully implanting a single aortic endograft without a paired one and highlights the need for constant monitoring and angiography during the procedure. Detailed instructions on handling the delivery catheter and endograft are provided to prevent damage or misalignment.
The document outlines procedures for implanting the Altura Endograft System, emphasizing positioning and alignment to ensure a proper seal and avoid complications like misalignment, endoleak, or vessel damage. It advises against fully implanting a single aortic endograft without a paired one and highlights the need for constant monitoring and angiography during the procedure. Detailed instructions on handling the delivery catheter and endograft are provided to prevent damage or misalignment.
Precautions and Recommendations
Key precautions include avoiding excessive force during catheter advancement, ensuring proper overlap of iliac and aortic endografts, and maintaining guidewire position. The document warns against rotating the delivery catheter after the suprarenal stent is released and advises on the careful use of compliant balloons to avoid vessel damage.
Key precautions include avoiding excessive force during catheter advancement, ensuring proper overlap of iliac and aortic endografts, and maintaining guidewire position. The document warns against rotating the delivery catheter after the suprarenal stent is released and advises on the careful use of compliant balloons to avoid vessel damage.
MRI Information
The Altura Endograft System is MR Conditional, safe for scanning under specific conditions (1.5T or 3.0T magnetic fields, maximum SAR of 2 W/kg). The document notes potential temperature rise and image artifacts during MRI.
The Altura Endograft System is MR Conditional, safe for scanning under specific conditions (1.5T or 3.0T magnetic fields, maximum SAR of 2 W/kg). The document notes potential temperature rise and image artifacts during MRI.
Potential Adverse Events
Adverse events include allergic reactions, aneurysm rupture, endograft migration, and various complications such as cardiac, renal, and neurologic issues. The document stresses the importance of maintaining renal artery patency and the risks associated with incomplete sealing or improper placement.
Adverse events include allergic reactions, aneurysm rupture, endograft migration, and various complications such as cardiac, renal, and neurologic issues. The document stresses the importance of maintaining renal artery patency and the risks associated with incomplete sealing or improper placement.
Patient Selection and Treatment
Patient selection criteria include age, life expectancy, co-morbidities, and anatomical suitability. The document advises on the necessary device diameters and emphasizes the importance of patient commitment to follow-up examinations.
Patient selection criteria include age, life expectancy, co-morbidities, and anatomical suitability. The document advises on the necessary device diameters and emphasizes the importance of patient commitment to follow-up examinations.
Patient Counseling
Physicians should discuss the risks and benefits of endovascular versus surgical repair with patients, emphasizing the need for lifelong follow-up to monitor the endograft's performance. Patients should be informed about the signs of complications and the importance of seeking prompt medical attention.
Physicians should discuss the risks and benefits of endovascular versus surgical repair with patients, emphasizing the need for lifelong follow-up to monitor the endograft's performance. Patients should be informed about the signs of complications and the importance of seeking prompt medical attention.
How Supplied
The Altura Endograft System is supplied sterile in a peel-open package for single use only. The document advises verifying the device's integrity and expiration date before use.
The Altura Endograft System is supplied sterile in a peel-open package for single use only. The document advises verifying the device's integrity and expiration date before use.
Clinical Use Information
The document stresses the importance of physician training and experience in vascular interventional techniques, recommending a qualified surgical team be available during procedures.
The document stresses the importance of physician training and experience in vascular interventional techniques, recommending a qualified surgical team be available during procedures.
Training and Team Requirements
Medical professionals involved in endovascular and surgical procedures must be adequately trained. A vascular surgery team should be on standby during implantation in case conversion to open surgery is needed.
Medical professionals involved in endovascular and surgical procedures must be adequately trained. A vascular surgery team should be on standby during implantation in case conversion to open surgery is needed.
Patient Selection and Follow-up
The Altura Endograft System is designed for specific aortic dimensions and requires careful anatomical consideration. Patients with certain conditions, such as intolerance to contrast media or specific anatomical challenges, may not be suitable candidates. Regular monitoring post-procedure is essential.
The Altura Endograft System is designed for specific aortic dimensions and requires careful anatomical consideration. Patients with certain conditions, such as intolerance to contrast media or specific anatomical challenges, may not be suitable candidates. Regular monitoring post-procedure is essential.
Imaging and Measurement Techniques
Accurate pre-procedural imaging, preferably using contrast-enhanced spiral CT angiography with 3D reconstruction, is crucial for assessing patient anatomy and ensuring proper endograft sizing and placement.
Accurate pre-procedural imaging, preferably using contrast-enhanced spiral CT angiography with 3D reconstruction, is crucial for assessing patient anatomy and ensuring proper endograft sizing and placement.
System Selection
Adherence to size recommendations is critical to avoid complications such as endoleaks or graft migration. Tables 1 and 2 provide detailed sizing guidelines.
Adherence to size recommendations is critical to avoid complications such as endoleaks or graft migration. Tables 1 and 2 provide detailed sizing guidelines.
Implantation Procedure
Proper imaging and systemic anticoagulation are necessary during the procedure. Care must be taken to avoid contamination and damage to the endograft and catheters. Fluoroscopy is used to ensure correct positioning and deployment of the endograft components.
Proper imaging and systemic anticoagulation are necessary during the procedure. Care must be taken to avoid contamination and damage to the endograft and catheters. Fluoroscopy is used to ensure correct positioning and deployment of the endograft components.
Post-implantation Considerations
Continuous monitoring of the endograft position is required to prevent complications such as migration or vessel occlusion. Any misalignment or incomplete sealing may necessitate surgical intervention.
Continuous monitoring of the endograft position is required to prevent complications such as migration or vessel occlusion. Any misalignment or incomplete sealing may necessitate surgical intervention.
Specifications and Precautions
1. Catheter Use: If resistance is felt during catheter insertion, stop immediately and investigate under fluoroscopy to prevent damage to the vessel, catheter, or endograft. Avoid using damaged or non-sterile catheters.
2. Balloon Use: Do not inflate the balloon outside the endograft to prevent vessel injury. Ensure the balloon is fully deflated before repositioning.
1. Catheter Use: If resistance is felt during catheter insertion, stop immediately and investigate under fluoroscopy to prevent damage to the vessel, catheter, or endograft. Avoid using damaged or non-sterile catheters.
2. Balloon Use: Do not inflate the balloon outside the endograft to prevent vessel injury. Ensure the balloon is fully deflated before repositioning.
MRI Compatibility
The Altura Endograft System is MRI conditional under specific conditions: 1.5 or 3.0 Tesla magnetic fields, a spatial gradient of 30 T/m or less, and a SAR of 2 W/kg. Expected temperature rise is 6.47°C after 15 minutes of continuous scanning.
The Altura Endograft System is MRI conditional under specific conditions: 1.5 or 3.0 Tesla magnetic fields, a spatial gradient of 30 T/m or less, and a SAR of 2 W/kg. Expected temperature rise is 6.47°C after 15 minutes of continuous scanning.
Potential Adverse Events
Possible complications include allergic reactions, aneurysm rupture, thrombosis, endograft migration, and more. Lifelong follow-up is necessary to monitor the endograft's function.
Possible complications include allergic reactions, aneurysm rupture, thrombosis, endograft migration, and more. Lifelong follow-up is necessary to monitor the endograft's function.
Patient Selection and Treatment
Consider patient age, comorbidities, and anatomical suitability. Ensure compatibility with the 14 French introducer sheath and absence of significant vascular disease.
Consider patient age, comorbidities, and anatomical suitability. Ensure compatibility with the 14 French introducer sheath and absence of significant vascular disease.
Patient Counseling
Discuss risks and benefits of endovascular vs. surgical repair, the need for lifelong follow-up, and potential complications such as radiation exposure and impotence.
Discuss risks and benefits of endovascular vs. surgical repair, the need for lifelong follow-up, and potential complications such as radiation exposure and impotence.
Product Handling
The system is sterilized with ethylene oxide and is for single use only. Inspect for damage before use and ensure correct product selection.
The system is sterilized with ethylene oxide and is for single use only. Inspect for damage before use and ensure correct product selection.
Clinical Use Information
1. Training: Only trained physicians should use the system. Familiarity with vascular intervention techniques is required.
2. Pre-Use Inspection: Check for transport damage and ensure correct product availability.
3. Required Materials: Include fluoroscopy equipment, contrast media, and various catheters and guidewires.
1. Training: Only trained physicians should use the system. Familiarity with vascular intervention techniques is required.
2. Pre-Use Inspection: Check for transport damage and ensure correct product availability.
3. Required Materials: Include fluoroscopy equipment, contrast media, and various catheters and guidewires.
Guidelines for Product Sizing
Choose diameters based on provided tables to ensure proper sealing and blood flow.
Choose diameters based on provided tables to ensure proper sealing and blood flow.
Pre-Procedure Planning
Evaluate anatomy using CT angiograms and select appropriate endografts. Ensure all recommended materials are ready for use.
Evaluate anatomy using CT angiograms and select appropriate endografts. Ensure all recommended materials are ready for use.
Specifications and Usage Instructions
The document provides detailed instructions for the use of the Altura Endograft System, emphasizing the importance of not using the catheter if the packaging is damaged or if the sterile barrier is compromised. It also advises against inflating the balloon outside the endograft to prevent damage and highlights the need for complete deflation before repositioning.
The document provides detailed instructions for the use of the Altura Endograft System, emphasizing the importance of not using the catheter if the packaging is damaged or if the sterile barrier is compromised. It also advises against inflating the balloon outside the endograft to prevent damage and highlights the need for complete deflation before repositioning.
Magnetic Resonance Imaging (MRI) Information
The Altura Endograft System is MRI compatible under specific conditions, including a static magnetic field of 1.5 or 3.0 teslas and a maximum spatial gradient field of 30 T/m. The device may cause a temperature increase of up to 6.47°C during a 15-minute continuous scan.
The Altura Endograft System is MRI compatible under specific conditions, including a static magnetic field of 1.5 or 3.0 teslas and a maximum spatial gradient field of 30 T/m. The device may cause a temperature increase of up to 6.47°C during a 15-minute continuous scan.
Potential Adverse Events
The document lists numerous potential adverse events, such as allergic reactions, aneurysm enlargement or rupture, arterial or venous thrombosis, and complications related to anesthesia. It also mentions the possibility of device-related issues like endograft misplacement, infection, or mechanical failure.
The document lists numerous potential adverse events, such as allergic reactions, aneurysm enlargement or rupture, arterial or venous thrombosis, and complications related to anesthesia. It also mentions the possibility of device-related issues like endograft misplacement, infection, or mechanical failure.
Patient Selection and Treatment
Patient selection should consider factors like age, life expectancy, and anatomical suitability for endovascular repair. The document stresses the importance of having all necessary device sizes available and highlights the need for a thorough evaluation of the patient's condition and risks.
Patient selection should consider factors like age, life expectancy, and anatomical suitability for endovascular repair. The document stresses the importance of having all necessary device sizes available and highlights the need for a thorough evaluation of the patient's condition and risks.
Patient Counseling
Before undergoing the procedure, patients should be informed about the risks and benefits of endovascular versus surgical repair. The document emphasizes the need for lifelong follow-up to monitor the endograft's condition and function.
Before undergoing the procedure, patients should be informed about the risks and benefits of endovascular versus surgical repair. The document emphasizes the need for lifelong follow-up to monitor the endograft's condition and function.
Product Presentation
The Altura Endograft System is supplied sterile and is intended for single use only. It should not be re-sterilized, and the packaging should be inspected for damage before use.
The Altura Endograft System is supplied sterile and is intended for single use only. It should not be re-sterilized, and the packaging should be inspected for damage before use.
Clinical Use Information
Only trained medical professionals should use the Altura Endograft System. The document outlines the necessary skills and experience required, including knowledge of aortic aneurysms, radiographic interpretation, and various surgical techniques.
Only trained medical professionals should use the Altura Endograft System. The document outlines the necessary skills and experience required, including knowledge of aortic aneurysms, radiographic interpretation, and various surgical techniques.
Pre-Procedure Planning
Pre-procedure planning involves reviewing angiographic images to assess anatomical features and selecting appropriate endografts. The document also lists the required and recommended materials for the procedure.
Pre-procedure planning involves reviewing angiographic images to assess anatomical features and selecting appropriate endografts. The document also lists the required and recommended materials for the procedure.
Specifications
The Altura Endograft System is designed for use in MRI environments with static magnetic fields of 1.5 or 3 teslas, a maximum spatial gradient field of 30 T/m, and a whole-body averaged specific absorption rate of 2 W/kg. Under these conditions, the system should not cause a temperature rise exceeding 6.47°C after 15 minutes of continuous operation. Non-clinical tests show image artifacts extending approximately 11 mm in a 3 tesla MRI system.
The Altura Endograft System is designed for use in MRI environments with static magnetic fields of 1.5 or 3 teslas, a maximum spatial gradient field of 30 T/m, and a whole-body averaged specific absorption rate of 2 W/kg. Under these conditions, the system should not cause a temperature rise exceeding 6.47°C after 15 minutes of continuous operation. Non-clinical tests show image artifacts extending approximately 11 mm in a 3 tesla MRI system.
Potential Adverse Events
Possible adverse events include allergic reactions, amputation, anesthesia complications, aneurysm dilation or rupture, aortic injuries, thrombosis, hemorrhage, cardiac complications, claudication, conversion to open surgery, death, embolism, endograft issues (e.g., incorrect placement, migration, occlusion), endoleak, fever, genitourinary complications, impotence, incomplete aneurysm repair, increased cancer risk, infection, lifelong follow-up requirements, liver failure, lymphatic complications, mechanical failure, neurological injuries, occlusion, pain, pulmonary complications, reduced blood flow, renal complications, surgery, vascular trauma, and wound complications.
Possible adverse events include allergic reactions, amputation, anesthesia complications, aneurysm dilation or rupture, aortic injuries, thrombosis, hemorrhage, cardiac complications, claudication, conversion to open surgery, death, embolism, endograft issues (e.g., incorrect placement, migration, occlusion), endoleak, fever, genitourinary complications, impotence, incomplete aneurysm repair, increased cancer risk, infection, lifelong follow-up requirements, liver failure, lymphatic complications, mechanical failure, neurological injuries, occlusion, pain, pulmonary complications, reduced blood flow, renal complications, surgery, vascular trauma, and wound complications.
Patient Selection and Treatment
Patient selection criteria include age, comorbidities, suitability for open or endovascular repair, risk comparison, anesthesia tolerance, and vessel morphology. The decision is at the discretion of the physician and patient.
Patient selection criteria include age, comorbidities, suitability for open or endovascular repair, risk comparison, anesthesia tolerance, and vessel morphology. The decision is at the discretion of the physician and patient.
Patient Advice
Patients should understand the differences between endovascular and surgical repair, the need for lifelong follow-up, and the potential for further interventions. They should be informed about the risks of radiation exposure and the importance of adhering to follow-up programs.
Patients should understand the differences between endovascular and surgical repair, the need for lifelong follow-up, and the potential for further interventions. They should be informed about the risks of radiation exposure and the importance of adhering to follow-up programs.
Presentation
The system is sterilized with ethylene oxide and provided in a peelable package. It is for single use only and should not be re-sterilized. Inspect the device and packaging for damage before use.
The system is sterilized with ethylene oxide and provided in a peelable package. It is for single use only and should not be re-sterilized. Inspect the device and packaging for damage before use.
Clinical Use Information
Qualified surgical teams should be available during implantation. Physicians should be trained in vascular techniques and device use. Pre-use inspection and correct device selection are crucial.
Qualified surgical teams should be available during implantation. Physicians should be trained in vascular techniques and device use. Pre-use inspection and correct device selection are crucial.
Required and Recommended Equipment
Includes fluoroscope, contrast products, syringes, heparinized saline, sterile gauze, vascular access kits, and various introducers and guidewires.
Includes fluoroscope, contrast products, syringes, heparinized saline, sterile gauze, vascular access kits, and various introducers and guidewires.
Device Calibration Guidelines
Device diameter should be selected according to provided tables to ensure proper sealing and blood flow.
Device diameter should be selected according to provided tables to ensure proper sealing and blood flow.
Pre-Procedure Planning
Evaluate anatomy using CT angiograms, select appropriate endografts, and confirm availability of recommended equipment. Anatomical criteria include vessel size and morphology compatibility.
Evaluate anatomy using CT angiograms, select appropriate endografts, and confirm availability of recommended equipment. Anatomical criteria include vessel size and morphology compatibility.
General Use Information
Standard techniques for arterial access and monitoring blood loss should be employed during the procedure.
Standard techniques for arterial access and monitoring blood loss should be employed during the procedure.
Specifications and Preparations
- Ensure a sterile field suitable for AAA surgical interventions in case conversion to open repair is necessary.
- Position the patient on the imaging table for fluoroscopic visualization from the aortic arch to femoral bifurcations.
- Administer sedatives and anticoagulants as per standard practices, considering alternatives if the patient is sensitive to heparin.
- Access the left and right femoral arteries percutaneously or surgically using appropriate techniques.
- Establish proximal and distal vascular control of both femoral vessels.
- Ensure a sterile field suitable for AAA surgical interventions in case conversion to open repair is necessary.
- Position the patient on the imaging table for fluoroscopic visualization from the aortic arch to femoral bifurcations.
- Administer sedatives and anticoagulants as per standard practices, considering alternatives if the patient is sensitive to heparin.
- Access the left and right femoral arteries percutaneously or surgically using appropriate techniques.
- Establish proximal and distal vascular control of both femoral vessels.
Implantation of Aortic Endografts
Preparation for Implantation:
- Use standard techniques to introduce a guidewire and angiographic flush catheter into the aorta, ensuring no significant anatomical changes since the preoperative CT angiography.
- Introduce 0.035" rigid guidewires and 14 F introducer sheaths on each side.
- Inspect and rinse aortic delivery catheters with heparinized saline, ensuring no damage.
Preparation for Implantation:
- Use standard techniques to introduce a guidewire and angiographic flush catheter into the aorta, ensuring no significant anatomical changes since the preoperative CT angiography.
- Introduce 0.035" rigid guidewires and 14 F introducer sheaths on each side.
- Inspect and rinse aortic delivery catheters with heparinized saline, ensuring no damage.
Initial Positioning and Deployment:
- Align radiographic control equipment and load aortic delivery catheters onto guidewires.
- Under fluoroscopic control, position the catheters near the target renal artery, ensuring guidewires remain in place.
- Rotate delivery catheters to align septal radiopaque markers with guidewires.
- Stabilize and partially deploy the endografts, ensuring correct alignment and positioning.
- Align radiographic control equipment and load aortic delivery catheters onto guidewires.
- Under fluoroscopic control, position the catheters near the target renal artery, ensuring guidewires remain in place.
- Rotate delivery catheters to align septal radiopaque markers with guidewires.
- Stabilize and partially deploy the endografts, ensuring correct alignment and positioning.
Renal Positioning and Expansion
- Verify renal artery position using diluted contrast injection, ensuring no graft occlusion.
- Partially deploy endografts, confirming correct apposition against the vascular wall.
- Ensure correct renal positioning before final deployment.
- Verify renal artery position using diluted contrast injection, ensuring no graft occlusion.
- Partially deploy endografts, confirming correct apposition against the vascular wall.
- Ensure correct renal positioning before final deployment.
Removal of Delivery Catheters
- Inspect and remove delivery catheters under fluoroscopic control, ensuring no displacement of the endograft.
- Leave introducer sheaths and guidewires in place.
- Inspect and remove delivery catheters under fluoroscopic control, ensuring no displacement of the endograft.
- Leave introducer sheaths and guidewires in place.
Implantation of Iliac Endografts
Preparation and Initial Positioning:
- Perform an angiogram to determine the location of internal iliac arteries.
- Inspect and rinse iliac delivery catheters, ensuring no damage.
- Under fluoroscopic control, position the iliac endograft distal to the sealing zone.
Preparation and Initial Positioning:
- Perform an angiogram to determine the location of internal iliac arteries.
- Inspect and rinse iliac delivery catheters, ensuring no damage.
- Under fluoroscopic control, position the iliac endograft distal to the sealing zone.
Deployment:
- Partially deploy the iliac endograft, ensuring correct alignment and positioning.
- Use diluted contrast to verify internal iliac artery position, ensuring sufficient flow.
- Adjust positioning as necessary during initial contact with the iliac artery.
- Partially deploy the iliac endograft, ensuring correct alignment and positioning.
- Use diluted contrast to verify internal iliac artery position, ensuring sufficient flow.
- Adjust positioning as necessary during initial contact with the iliac artery.
Preoperative Planning
- Examine CT angiograms to assess the anatomy of the aortic neck, aneurysm sac, and iliac artery.
- Select aortic and iliac endografts that best fit the patient's anatomy.
- Ensure recommended materials are available and ready for use.
- Anatomical requirements include compatible iliac-femoral access vessel size and morphology, a proximal aortic neck length of at least 15 mm with a luminal diameter between 18 mm and 28 mm, and a distal iliac artery fixation site with a length of at least 15 mm and a luminal diameter between 8 mm and 18 mm.
General Usage Information
- The use of the Altura Endograft System involves standard techniques for positioning arterial access sheaths, guide catheters, angiographic catheters, and guidewires.
- Monitor blood loss throughout the procedure and provide appropriate treatment if excessive loss occurs.
Patient Preparation
- Prepare the patient and surgical drapes for a potential open AAA repair.
- Position the patient for fluoroscopic visualization from the aortic arch to femoral bifurcations.
- Sedate and anticoagulate the patient according to standard protocols, considering alternatives if the patient is heparin-sensitive.
- Access the femoral arteries percutaneously or surgically and establish proximal and distal vascular control.
Aortic Endograft Implantation Procedure
- Introduce a guidewire and angiographic flush catheter into the aorta to evaluate the vascular system and ensure anatomical criteria are met.
- Introduce 0.035" guidewires bilaterally and advance them to the thoracic aorta.
- Insert 14 F sheath introducers bilaterally.
- Inspect and prepare the aortic endograft delivery catheters, ensuring no damage is present.
- Rotate the delivery catheter to ensure proper rotation of the apical cap.
Initial Tracking and Positioning
- Align fluoroscopic equipment with the chosen imaging orientation.
- Load and advance the aortic endograft delivery catheters under fluoroscopic guidance to the target renal artery.
- Stabilize the delivery catheter handle and retract the outer sheath to align radiopaque markers.
Renal Positioning and Expansion
- Verify renal artery position using diluted contrast material.
- Adjust endograft positioning to ensure graft material is below the renal arteries without occlusion.
- Expand the endografts to achieve adequate apposition to the vessel wall.
Release and Removal
- Remove the safety collar and release the suprarenal stent.
- Remove the delivery catheters one at a time, ensuring they do not snag on the endograft or sheath introducer.
Iliac Endograft Implantation Procedure
- Perform angiography of the iliac arteries to determine the position of the internal iliac arteries.
Specifications and Components
The Altura Endograft System consists of two aortic and two iliac endovascular prostheses, each pre-loaded in a 14 F delivery catheter. The aortic prostheses are positioned in the abdominal aorta, while the iliac prostheses are positioned relative to the intended sealing zone. The system includes components made from nitinol, polyester, tantalum, and UHMWPE.
The Altura Endograft System consists of two aortic and two iliac endovascular prostheses, each pre-loaded in a 14 F delivery catheter. The aortic prostheses are positioned in the abdominal aorta, while the iliac prostheses are positioned relative to the intended sealing zone. The system includes components made from nitinol, polyester, tantalum, and UHMWPE.
Procedures
Inspection and Preparation: Inspect the delivery catheters for damage before use. Irrigate the lumens with heparinized saline until a steady flow is achieved.
Tracking and Initial Positioning: Align fluoroscopic equipment and advance the delivery catheter under guidance to the intended position.
Positioning: Rotate the catheter handle to release the iliac endograft, ensuring proper alignment and expansion.
Removal: Carefully retract the delivery catheter, ensuring it does not snag on the endograft.
Balloon Dilatation: Inflate balloons to appose the endografts to the aortic wall.
Post-Implantation Aortography: Verify the patency of renal and iliac arteries and check for endoleaks.
Inspection and Preparation: Inspect the delivery catheters for damage before use. Irrigate the lumens with heparinized saline until a steady flow is achieved.
Tracking and Initial Positioning: Align fluoroscopic equipment and advance the delivery catheter under guidance to the intended position.
Positioning: Rotate the catheter handle to release the iliac endograft, ensuring proper alignment and expansion.
Removal: Carefully retract the delivery catheter, ensuring it does not snag on the endograft.
Balloon Dilatation: Inflate balloons to appose the endografts to the aortic wall.
Post-Implantation Aortography: Verify the patency of renal and iliac arteries and check for endoleaks.
Storage and Handling
Handle all components carefully to avoid damage. Store in a cool, dry place to maintain sterility and integrity.
Handle all components carefully to avoid damage. Store in a cool, dry place to maintain sterility and integrity.
Warranty and Liability
Altura Medical guarantees careful design and manufacture but does not ensure effective results or absence of adverse effects. Liability is limited to product replacement if defects are found.
Altura Medical guarantees careful design and manufacture but does not ensure effective results or absence of adverse effects. Liability is limited to product replacement if defects are found.
Patient Preparation
Patients must be prepared and draped for a surgical AAA procedure in case the operation type needs to change to open surgical intervention. The patient should be positioned on the imaging table to visualize the area from the aortic arch to the femoral artery branches. Standard sedatives and anticoagulants should be administered, with alternatives considered if the patient is sensitive to heparin. Access to the femoral artery should be achieved either percutaneously or surgically, ensuring vascular control proximally and distally.
Patients must be prepared and draped for a surgical AAA procedure in case the operation type needs to change to open surgical intervention. The patient should be positioned on the imaging table to visualize the area from the aortic arch to the femoral artery branches. Standard sedatives and anticoagulants should be administered, with alternatives considered if the patient is sensitive to heparin. Access to the femoral artery should be achieved either percutaneously or surgically, ensuring vascular control proximally and distally.
Implantation Procedure: Aortic Endovascular Prostheses
Preparation for Implantation
Guidewires and angiographic catheters are introduced into the aorta to assess abdominal vessels and ensure no significant anatomical changes have occurred since preoperative imaging. Bilateral 0.035" guidewires and 14 F introducer sheaths are inserted. The integrity of the endovascular prosthesis delivery catheter packaging is checked before use. Catheters are flushed with sterile saline to ensure a steady flow.
Preparation for Implantation
Guidewires and angiographic catheters are introduced into the aorta to assess abdominal vessels and ensure no significant anatomical changes have occurred since preoperative imaging. Bilateral 0.035" guidewires and 14 F introducer sheaths are inserted. The integrity of the endovascular prosthesis delivery catheter packaging is checked before use. Catheters are flushed with sterile saline to ensure a steady flow.
Guidance and Initial Positioning
Fluoroscopic equipment is used to guide the delivery catheters to the planned renal artery location. The catheters are rotated to ensure the transverse radiopaque markers are parallel. The delivery catheter's front grip is stabilized, and the outer sheath is retracted to deploy the prosthesis.
Fluoroscopic equipment is used to guide the delivery catheters to the planned renal artery location. The catheters are rotated to ensure the transverse radiopaque markers are parallel. The delivery catheter's front grip is stabilized, and the outer sheath is retracted to deploy the prosthesis.
Positioning and Expansion in Renal Arteries
The position of the renal arteries is verified using diluted contrast medium. The endovascular prostheses are carefully moved to ensure coverage material does not obstruct the renal arteries. The prostheses are expanded to fit the vessel wall.
The position of the renal arteries is verified using diluted contrast medium. The endovascular prostheses are carefully moved to ensure coverage material does not obstruct the renal arteries. The prostheses are expanded to fit the vessel wall.
Removal of Delivery Catheter
The delivery catheters are removed one at a time, ensuring guidewire and sheath positions remain stable. Care is taken to avoid snagging the prosthesis during removal.
The delivery catheters are removed one at a time, ensuring guidewire and sheath positions remain stable. Care is taken to avoid snagging the prosthesis during removal.
Implantation Procedure: Pelvic Artery Endovascular Prostheses
Preparation for Implantation
A pelvic artery angiogram is performed to locate the internal pelvic arteries. The integrity of the delivery catheter packaging is checked before use. The catheter lumens are flushed with sterile saline.
Preparation for Implantation
A pelvic artery angiogram is performed to locate the internal pelvic arteries. The integrity of the delivery catheter packaging is checked before use. The catheter lumens are flushed with sterile saline.
Guidance and Initial Positioning
Fluoroscopic guidance is used to position the delivery catheter distal to the intended closure zone. The catheter is advanced carefully to avoid snagging on previously deployed prostheses.
Fluoroscopic guidance is used to position the delivery catheter distal to the intended closure zone. The catheter is advanced carefully to avoid snagging on previously deployed prostheses.
Deployment
The pelvic artery prosthesis is partially deployed by rotating the delivery catheter handle. The position of the internal pelvic arteries is verified using diluted contrast medium. The prosthesis is adjusted proximally if necessary.
The pelvic artery prosthesis is partially deployed by rotating the delivery catheter handle. The position of the internal pelvic arteries is verified using diluted contrast medium. The prosthesis is adjusted proximally if necessary.
Removal of Delivery Catheter
The delivery catheter is removed carefully, ensuring it does not snag on the prosthesis or vascular sheath. If resistance is felt, the outer sheath can be retracted to facilitate removal.
The delivery catheter is removed carefully, ensuring it does not snag on the prosthesis or vascular sheath. If resistance is felt, the outer sheath can be retracted to facilitate removal.
Specifications and Recommendations
The Altura Endograft System is not recommended for patients who cannot tolerate contrast agents required for imaging during intraoperative and postoperative monitoring. Patients should be closely monitored for changes in their condition and the integrity of the endograft. It is also not recommended for patients with excessive weight or size limitations that hinder necessary imaging requirements. Specific imaging and accurate measurements are crucial for successful patient selection.
The Altura Endograft System is not recommended for patients who cannot tolerate contrast agents required for imaging during intraoperative and postoperative monitoring. Patients should be closely monitored for changes in their condition and the integrity of the endograft. It is also not recommended for patients with excessive weight or size limitations that hinder necessary imaging requirements. Specific imaging and accurate measurements are crucial for successful patient selection.
Imaging Techniques
Preoperative imaging should include contrast-enhanced spiral CT angiography with 3D reconstruction to accurately assess patient anatomy. If unavailable, patients should be referred to a facility with these capabilities. Proper imaging is essential to avoid missing iliac or aortic calcification, which can impede device access or fixation.
Preoperative imaging should include contrast-enhanced spiral CT angiography with 3D reconstruction to accurately assess patient anatomy. If unavailable, patients should be referred to a facility with these capabilities. Proper imaging is essential to avoid missing iliac or aortic calcification, which can impede device access or fixation.
Device Selection
Strict adherence to the sizing guidelines in the Altura Endograft System's instructions is recommended. Incorrect sizing can lead to endoleakage, fracture, migration, or lumen loss.
Strict adherence to the sizing guidelines in the Altura Endograft System's instructions is recommended. Incorrect sizing can lead to endoleakage, fracture, migration, or lumen loss.
Implantation Procedure
Accurate imaging during the procedure is necessary for successful positioning of the endograft. Systemic anticoagulants should be used according to hospital protocol. Care should be taken to minimize handling of the constrained endograft and placement catheter to reduce contamination risk. Proper alignment and fixation are crucial to prevent endoleakage and migration.
Accurate imaging during the procedure is necessary for successful positioning of the endograft. Systemic anticoagulants should be used according to hospital protocol. Care should be taken to minimize handling of the constrained endograft and placement catheter to reduce contamination risk. Proper alignment and fixation are crucial to prevent endoleakage and migration.
Use of Compliant Balloon
The balloon should not be inflated outside the endograft to avoid vessel damage. Care is needed when inflating the balloon in the presence of calcification.
The balloon should not be inflated outside the endograft to avoid vessel damage. Care is needed when inflating the balloon in the presence of calcification.
MRI Information
The Altura Endograft System is MR Conditional, allowing safe scanning under specific conditions, including a static magnetic field of 1.5 or 3.0 tesla and a maximum SAR of 2 W/kg.
The Altura Endograft System is MR Conditional, allowing safe scanning under specific conditions, including a static magnetic field of 1.5 or 3.0 tesla and a maximum SAR of 2 W/kg.
Potential Adverse Events
Possible adverse events include allergic reactions to contrast agents, aneurysm enlargement or rupture, aortic damage, and arterial or venous thrombosis.
Possible adverse events include allergic reactions to contrast agents, aneurysm enlargement or rupture, aortic damage, and arterial or venous thrombosis.
Altura Endograft System – Instructions for Use
Specifications and Components
- The document provides multilingual descriptions of the components of the Altura Endograft System, including the iliac endograft loading zone, white tip, top cap, and outer sheath.
- Figures illustrate the positioning and rotation of components on the aortic delivery catheter, emphasizing the importance of correct orientation for effective deployment.
Procedures
- Instructions for rotating the top cap at least 180° relative to the outer sheath are provided to ensure proper alignment during the procedure.
- Figures demonstrate the correct anterior-posterior and lateral views of septal radiopaque markers, indicating proper aortic endograft orientation.
Symbols Glossary
- A comprehensive glossary of symbols used in the documentation is provided, covering terms such as batch code, do not reuse, catalogue number, manufacturer, sterilization methods, and usage warnings.
- Symbols indicate conditions like MR Conditional, presence of phthalates, and storage instructions (e.g., keep dry, keep away from sunlight).
Manufacturer Information
- Lombard Medical Ltd, located in Didcot, United Kingdom, is identified as the manufacturer.
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Catalog excerpts
Altura™ Endograft System Instructions for Use Altura™ Endograft System Gebrauchsanweisung Altura™ Endograft System Modo de empleo Altura™ Endograft System Mode d’emploi Altura™ Endograft System Istruzioni per l’uso Altura™ Endograft System Lietošanas pamācība Altura™ Endograft System Gebruiksaanwijzing Altura™ Endograft System Instrukcja użycia Altura™ Endograf
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READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS, WARNINGS, AND PRECAUTIONS MAY LEAD TO SERIOUS SURGICAL CONSEQUENCES OR INJURY TO THE PATIENT. 1.0 Product Description The Altura™ Endograft System is comprised of two (2) bilateral aortic endografts and two (2) iliac endografts. Each endograft is pre-loaded into a 14 F delivery catheter. Each catheter is intended to be introduced into the femoral artery over a guidewire under fluoroscopic guidance. The two aortic endografts are advanced into the abdominal aorta, aligned, and positioned. The endografts are deployed such...
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1.1.2. Delivery Catheter The Altura Endograft System delivery catheters are single use disposable devices used to deliver the aortic (Figure 4 and Figure 5) and iliac (Figure 6 and Figure 7) endografts. The aortic endografts are deployed in a proximal to distal fashion while the iliac endografts are deployed in a distal to proximal fashion. Both types of endografts are delivered using 14 F introducer sheath compatible delivery catheters that contain 0.035” (0.89 mm) guidewire compatible lumens and radiopaque atraumatic tips. Endograft deployment is accomplished by rotating the rear grip of the...
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• Inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvis/bowel ischemia. • Multiple large, patent lumbar arteries, and a patent inferior mesenteric artery may predispose a patient to Type II endoleaks. Patients with uncorrectable coagulopathy may also have an increased risk of Type II endoleak or bleeding complications. • The Altura Endograft System has not been evaluated in the following patient populations: o Traumatic aortic injury Leaking, dissecting, pending rupture, or ruptured aneurysms...
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• Do not fully implant a single aortic endograft within the aorta without a paired aortic endograft positioned, aligned, and partially expanded alongside. Fully implanting only one aortic endograft at a time can result in misalignment and improper positioning of the endograft within the aortic neck, resulting in an inadequate seal. • As the sheath and/or guidewire is withdrawn, anatomy and endograft position may change. Constantly monitor endograft position and perform angiography to check position as necessary. • To avoid any twist in the endovascular endograft, during any rotation of the delivery...
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Non-clinical testing has demonstrated that the Altura Endograft System endografts are MR Conditional. Patients with this device can be scanned safely in an MR system meeting the following conditions: • Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T) • Maximum spatial gradient field less than or equal to 30 T/m (3000 gauss/cm) • Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode) Under the scan conditions defined above, the Altura Endograft System endografts are expected to produce a maximum temperature rise of 6.47°C after...
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• Wound complications and subsequent attendant problems (e.g., infection, dehiscence, bleeding, pseudoaneurysm) 6.0 Patient Selection and Treatment Individualization and Treatment Altura recommends that the Altura Endograft System endograft diameters be selected as describe in Table 1 and Table 2. All device diameters potentially necessary to complete the procedure should be available. Considerations for patient selection include, but are not limited to: • Patient’s age and life expectancy • Co-morbidities (e.g. cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity) • Patient’s...
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9.0 Clinical Use Information 9.1. Physician Training and Experience CAUTION: Always have a qualified surgery team available during implantation or re-intervention procedures in the event that conversion to open surgical repair is necessary. CAUTION: The Altura Endograft System should only be used by physicians and teams trained in vascular interventional techniques and in the use of this device. The recommended skill/knowledge requirements for physicians using the Altura Endograft System are outlined below: Patient Selection: • Knowledge of the natural history of abdominal aortic aneurysms (AAA)...
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10.0 Directions for Use 10.1. Pre-Procedure Planning • Review CT angiograms (CTA) to assess aortic neck, aneurysm sac, and iliac artery anatomy. Select aortic and iliac endografts best suited for the anatomy. Confirm the recommended materials are available and ready for use. Anatomical requirements: I liofemoral access vessel size and morphology (minimal thrombus, calcium, and/or tortuosity) should be compatible with vascular access techniques and accessories. Arterial conduit techniques may be required. P roximal aortic neck lengths should be equal to or greater than of 15 mm with a lumen diameter...
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• Confirm that the septal radiopaque markers are parallel to and are inside of their respective guidewires. The endografts are rotated by turning the entire delivery catheter. Note: To move the stent expander to expand or collapse the endograft, the lock must be pressed. To secure the stent expander in place, release the lock. • Stabilize the front grip and move the stent expander toward the rear of the delivery catheter to partially expand the exposed portion of the aortic endograft. Repeat this step for the contralateral device if simultaneously deploying both aortic endografts. Note: If resistance...
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