Specifications and Description: The TITAN OPTIMAX is a coronary
stent system designed to enhance coronary luminal diameters. It is constructed from L605 cobalt-chromium alloy and coated with Titanium Nitride Oxide (TiNO) to reduce post-operative restenosis. The stent is flexible and deployable via a balloon
catheter.
Clinical Benefits and Safety: The stent aims to prevent myocardial infarction with a minimally invasive procedure that does not require general anesthesia or major surgery. It ensures the reopening of stenosed arteries.
Instructions for Use: Detailed procedures for vessel preparation, stent size selection, and deployment are provided. Key steps include preparing a 50% contrast solution, ensuring proper stent placement, and using fluoroscopy for guidance. Recommendations for multiple stent placements and handling are also included.
Limitations and Warranty: HEXACATH guarantees the quality of the TITAN OPTIMAX system but limits its liability to device replacement. The company is not responsible for indirect damages or issues arising from factors beyond its control, such as patient conditions or procedural errors.
Magnetic Resonance Imaging (MRI) Compatibility: The stent is compatible with MRI under specific conditions, including a static magnetic field of 1.5 or 3 Tesla. Tests show a maximum temperature rise of 3.1°C after 15 minutes of scanning.
Data Summary: Clinical data over 12 and 18 months show various outcomes, including mortality rates, myocardial infarction, and revascularization statistics. The document provides detailed percentages for different patient groups.
Manufacturer Information: HEXACATH, located in Rueil-Malmaison, France, provides contact details for further inquiries.
Specifications: The TiTAN OPTIMAX stent system features a TiNO coating that varies between 14% and 23% depending on the stent diameter. The delivery catheter includes a flexible distal tip, balloon, and polymer tubes, with a stainless steel hypotube. It is coated with a non-active hydrophilic layer. The balloon has two radiopaque markers for stent positioning and additional markers for catheter positioning relative to a guide catheter.
Packaging and Contents: The stent is packaged in a sterile peelable pouch and cardboard case, including an instruction leaflet, compliance card, and implant card. Available stent lengths range from 7 mm to 38 mm, with diameters from 2.0 mm to 5.0 mm.
Indications: Indicated for improving coronary luminal diameters in adults with symptomatic ischemic heart disease, including acute myocardial infarction and diabetes-related coronary artery lesions. Suitable for lesions shorter than the stent length and vessel diameters between 2.0 mm and 5.0 mm.
Contraindications: Not suitable for patients unable to receive anticoagulant/antiplatelet therapy, those allergic to contrast agents or TiNO, recent major surgery, bleeding history, pregnancy, and certain lesion types.
Adverse Effects: Observed effects include stent thrombosis and myocardial infarction. Potential effects cover allergic reactions, angina, arrhythmias, bleeding, coronary artery spasm, and more.
Warnings: Implantation should occur in authorized hospitals by experienced physicians. Do not use expired, damaged, or re-sterilized devices. Ensure catheter integrity and follow aseptic conditions.
Precautions: Store properly, use before expiry, and ensure device integrity before use. Administer appropriate medications prior to catheter insertion.
Recommended Equipment: Includes a puncture kit, guide catheter, coronary guide, syringe, haemostasis valve, stopcock, inflation device, and solutions.
Operating Instructions: Details preparation of the vessel, stent size selection, and installation system preparation. Emphasizes careful handling to avoid stent displacement and proper use of fluoroscopy during insertion.
Specifications and Procedures: The document provides detailed instructions for the deployment and management of the TiTAN OPTIMAX
coronary stent. Key procedures include ensuring the guide catheter is stable to prevent stent damage, performing inflations to achieve a stent diameter 10% larger than the vessel, and using intravascular ultrasound for assessment. It warns against exceeding the nominal burst pressure and emphasizes proper stent placement.
General and Specific Recommendations: General recommendations stress the importance of stent adherence to the balloon. Specific guidelines for multiple stent placements suggest starting distally and overlapping stents if necessary. Removal procedures highlight careful deflation and withdrawal to prevent stent loss.
Magnetic Resonance Imaging (MRI) Compatibility: The TiTAN OPTIMAX stent is MR Conditional, safe under specific conditions such as a static magnetic field of 1.5-Tesla or 3-Tesla, with a maximum SAR of 2-W/kg for 15 minutes. The stent may cause a temperature rise of 3.1°C and an image artifact extending 5-mm.
Disposal and Safety: Post-use disposal must comply with local regulations to prevent infection risks. The stent's performance features include reopening stenotic arteries and minimizing restenosis due to its TiNO coating. Clinical benefits include preventing heart attacks and offering a minimally invasive procedure.
Product Limitations and Warranties: HEXACATH guarantees the stent's quality but limits liability to device replacement. The company is not responsible for outcomes affected by factors beyond its control, such as patient conditions or improper handling.
Manufacturer Information: HEXACATH is located in Rueil-Malmaison, France, providing contact details for further inquiries.
Specifications and Precautions: The document emphasizes the importance of verifying the flawless connection of stent components before insertion to prevent stent loss, which could lead to myocardial infarction or death. Stents can cause artifacts in MRI due to magnetic field distortion, and MRI should only be performed after complete endothelialization, at least three months post-implantation.
Storage and Usage Guidelines: The product should be used before the expiration date and stored between 0°C and 40°C, protected from light and moisture. It is sterilized with ethylene oxide and is for single use only. Do not use if the packaging is damaged or opened.
Clinical Data: Statistics from follow-up studies show mortality and complication rates at various intervals post-implantation, highlighting the importance of monitoring.
Recommended Equipment: Includes a puncture set, catheter sheaths of specific sizes, a syringe, a hemostatic valve, a three-way stopcock, an inflation device, and heparinized saline.
Usage Instructions: Detailed steps for preparing the vessel, selecting stent size, and preparing the delivery system are provided. Emphasis is placed on ensuring no air bubbles remain in the system and maintaining the stent's position on the balloon.
Stent Placement and Inflation: Instructions for inserting the stent into the lesion under fluoroscopic control, ensuring proper placement and inflation to a diameter ratio of 1.1/1 with the artery. Recommendations for using multiple stents and handling resistance during insertion are included.
MRI Compatibility: The stent is compatible with MRI under specific conditions, with a maximum temperature increase of 3.1°C after 15 minutes of scanning.
Disposal: Product and packaging should be disposed of according to local regulations to prevent infection risks.
Recommended Materials: The document specifies the necessary materials for the procedure, including a puncture kit, appropriate guide catheters, coronary guidewires, syringes, hemostatic valves, and inflation devices. It emphasizes the importance of using the correct size and type of equipment to ensure the successful deployment of the TiTAN OPTIMAX stent.
Instructions for Use: Detailed steps are provided for preparing the vessel, selecting the appropriate stent size, and preparing the delivery system. The document outlines the importance of ensuring no air bubbles are present and maintaining negative pressure during preparation. It also provides guidance on the introduction and deployment of the stent, emphasizing the need for careful handling to avoid damage or misplacement.
General and Specific Recommendations: The document advises on the placement of multiple stents, recommending positioning from the distal to the proximal end of the lesion. It also provides instructions for the removal and disassembly of the system, highlighting the importance of maintaining negative pressure and avoiding excessive force.
Magnetic Resonance Imaging (MRI) Compatibility: The TiTAN OPTIMAX stent is compatible with MRI under specific conditions, including a static magnetic field of 1.5 Tesla or 3 Tesla. The document details the expected temperature increase and potential artifacts during MRI procedures.
Clinical Benefit, Safety, and Performance: The stent is designed to reopen stenotic arteries and minimize postoperative restenosis. The clinical benefits include the prevention of heart attacks and the minimally invasive nature of the procedure.
Limitations and Warranties: HEXACATH guarantees the quality of the TiTAN OPTIMAX system but limits its liability to the replacement of the device. The document disclaims responsibility for any indirect or incidental damages and emphasizes that the device should not be reused or reprocessed.
Specifications and Description: TITAN OPTIMAX is a coronary stent system pre-mounted on a
balloon catheter, designed for implantation in native coronary arteries or grafts to improve luminal diameters. Made from cobalt-chromium alloy, it features a titanium nitride oxide (TiNO) coating to minimize restenosis. The stent is available in various lengths (7-38 mm) and diameters (2.0-5.0 mm).
Indications and Contraindications: The stent is indicated for improving coronary artery luminal diameter in adults with symptomatic ischemic heart disease, including acute myocardial infarction and diabetes. Contraindications include patients unable to take anticoagulants, recent major surgery, pregnancy, and known allergies to TiNO.
Adverse Effects: Observed adverse effects include those from clinical studies such as TIDES-ACS and TIOMAX. Potential adverse effects include myocardial infarction, stent migration, and allergic reactions.
Warnings and Precautions: Stent implantation should only be performed in authorized hospitals with experienced personnel. The device should not be reused or resterilized. Ensure the integrity of the catheter and stent before use.
Recommendations for Use: Use appropriate accessories such as a guiding catheter and inflation device. Maintain aseptic conditions throughout the procedure.
Magnetic Resonance Imaging (MRI) Compatibility: The stent is MRI compatible under specific conditions: static magnetic field of 1.5 T or 3 T, and a maximum spatial gradient of 1,900 gauss/cm. Expected temperature rise is 3.1°C after 15 minutes of scanning.
Product Disposal: Dispose of the product and packaging according to local regulations to prevent infection risks.
Clinical Benefits and Performance: The stent aims to prevent myocardial infarction and is minimally invasive. Performance characteristics are available on the manufacturer's website.
Limited Warranty: HEXACATH guarantees the product's design and manufacturing quality, limiting liability to product replacement only.
Specifications and Precautions: The document outlines the use of the TiTAN OPTIMAX coronary stent system, emphasizing the importance of ensuring the stent is securely attached to the balloon before inflation to prevent stent loss, which could lead to myocardial infarction or death. It highlights the potential for MRI artifacts due to the stent's cobalt alloy and recommends MRI only after full endothelialization, at least three months post-implantation. The device should be used before its expiration date, stored between 0°C and 40°C, and not used if the packaging is damaged.
Recommended Materials: Includes a lumbar puncture set, appropriately sized guiding catheters, coronary guidewires, syringes, hemostatic valves, three-way stopcocks, inflation devices, heparinized saline, and diluted contrast medium.
Procedure Guidelines: The document provides detailed steps for preparing the stent placement system, including flushing the catheter, ensuring no air bubbles, and maintaining negative pressure. It advises on the introduction of the stent under fluoroscopy, ensuring proper placement and inflation to achieve a stent-to-artery diameter ratio of 1.1/1. Recommendations for multiple stent placements and removal procedures are also included.
MRI Compatibility: TiTAN OPTIMAX stents are compatible with MRI under specific conditions, including static magnetic fields of 1.5 Tesla or 3 Tesla, with a maximum spatial gradient of 1,900 gauss/cm. The stents may cause artifacts extending 5 mm beyond the stent.
Clinical Performance: The stent system is designed to reopen narrowed coronary arteries and minimize postoperative narrowing due to its TiNO coating.
