Altura™
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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

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...

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...

• 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...

• 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...

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...

• 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) •...

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...

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...

• 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...

• Flush the implant and guidewire lumens of the delivery catheters with sterile heparinized saline while holding the tip elevated until a steady, constant stream exits the catheter. 10.5.2. Tracking and Initial Positioning • Align the fluoroscopic guidance equipment to the preferred imaging orientation of the native anatomy. • Under fluoroscopic guidance, advance the delivery catheter until the distal end of the iliac endograft is approximately 1 cm distal to the intended seal zone. Use care to ensure the iliac delivery catheter does not catch on the previously deployed aortic endograft....