The protege everflex selfexpanding biliary stent system is intended. Used for temporary internal drainage from the ureteropelvic junction to the bladder. The everflex stent is made of a nickel titanium alloy nitinol and is available in diameters 6, 7, and 8 mm and lengths 20, 30, 40, 60, 80, 100, 120, 150, and 200 mm. Post a free request for proposal for a ev3 prb3508040080 protege everflex selfexpanding biliary stent system 8mm x 40 mm 80cm and get quotes from our gold service dealers similar equipment for. Everflex selfexpanding peripheral stent system ordering. First clinical experience with the innova versus the protege everflex selfexpanding bare metal stents in superficial femoral artery occlusions.
New data from the durability iliac trial confirm the safety and effectiveness of primary stenting with two selfexpanding stent systems for the treatment of symptomatic iliac artery disease. Oneyear followup after implantation of the everflex. Pdf results of the protege everflex 200mmlong nitinol. Aug 01, 2019 the everflex selfexpanding stent system was evaluated in a study and proximal popliteal by using the everflex nitlnol stent system ii. Fortyone everflex stents were implanted in 32 patients with either superficial femoral artery occlusions n 20 or stenoses n 12. In addition to the new indication, it is now available in a 200 mm length. Medtronic launches the entrust delivery system in the united. The everflex selfexpanding stent system was evaluated in a study and proximal popliteal by using the everflex nitlnol stent system ii. Transbrachial access for stenting of femoropopliteal lesions. Request pdf twelvemonth results of the everflex stent in the superficial femoral artery to evaluate the clinical efficacy of everflex stents length, 620 cm for the treatment of peripheral. Between march 2008 and june 2009, 100 patients 66 men presenting with 100 symptomatic tasc c and d femoropopliteal lesions were treated with at. Background the newgeneration fluoropolymerbased pes showed promising outcomes in short femoropopliteal lesions.
In april 2015, the protege everflex stent has received fda approval for. Mechanical properties of the gore tigris vascular stent. We are a liquidator of sutures and other surgical items from ethicon, covidien autosuture, synthes, stryker, arthrex and are able to pass our savings on to you. Protege everflex nitinol stent system ii 24, the u. Oct 27, 2014 the everflex selfexpanding peripheral stent system has received fda approval for the treatment of atherosclerosis in the iliac arteries. Mdt has proven to provide sustained patency in the treatment of long, complex lesions in the superficial femoral sfa and popliteal arteries, according to the threeyear results of the durability ii study, which are reported in the recent issue of catheterization and. Stent lengths and diameters available for use in the study are shown in the appendix. The everflex medtroniccovidien, plymouth, minn baremetal stent was used. Secondary outcomes were secondary patency rate, amputation free survival afs, and freedom. The new medical device is designed for the treatment of peripheral arterial disease and is designed to be the most durable addition to the everflex range, which made its debut in 2006. Find this technical manual in the product labeling supplied with each device or by. To learn more about supera stent, simply request a free demonstration and. The everflex selfexpanding peripheral stent system everflex stent is a selfexpanding nitinol stent system intended for permanent implantation. A single stent strategy in patients with lifestyle.
Between june 2010 and february 2012, 83 patients with superficial femoral artery instent and rutherford category 2 to 5. Objectives the aim of this study was to assess the performance of the fluoropolymerbased paclitaxeleluting stent pes in long femoropopliteal lesions. Results of the protege everflex 200mmlong nitinol stent. Everflex peripheral stent indications, safety, and warnings.
Medtronic launches the entrust delivery system in the. Fda approves peripheral stent system for iliac disease. Results of primary stent therapy for femoropopliteal. The latest version of the everflex stent features the new entrust delivery system, which enables physicians to consistently place stents with accuracy, while providing the ease of a onehanded device. Everflex selfexpanding peripheral stent with entrust. Members receive wholesale pricing up to 33% off nonmember cost and other benefits. Treat peripheral artery disease with the everflex selfexpanding biliary stent. Initial studies with this stent platform in the durability i study of 151 subjects with claudication showed freedom from restenosis of 91. The everflex selfexpanding peripheral stent system everflex stent is a self expanding nitinol. Received ce mark for the protege everflex selfexpanding stent system for general use in the peripheral vasculature, including common and external iliac, subclavian and the superficial femoral artery on march 9, 2006 received fda approval on march 18, 2008 for a. Twelvemonth results of the everflex stent in the superficial. The everflex selfexpanding peripheral stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common andor external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 4. Between march 2008 and june 2009, 100 patients 66 men presenting with 100 symptomatic tasc c and d femoropopliteal lesions were treated with at least one 200mmlong protege everflex stent.
The stent is cut from a nitinol tube in an open lattice design, and has. Comparison of femoropopliteal artery stents under axial. Revelutionizing drugeluting technologies boston scientific. First clinical experience with the innova versus the. Secondary outcomes were secondary patency rate, amputation free survival afs, and freedom from target lesion revascularization tlr. The everflex selfexpanding peripheral stent system has received fda approval for the treatment of atherosclerosis in the iliac arteries. The main feature of the stent is its controlled and sustained paclitaxel. Engineered by a unique interwoven wire technology, this nitinol stent offers physicians unmatched clinical outcomes 516 across varied lesion complexities and lengths. Based on physician feedback and procedural observation, we developed an easy to use onehanded delivery system to increase the stent delivery options in our portfolio, said.
Stent size fr stent length cm wire guide diameter inch. Covidien launches everflex plus stent system in europe. The control stent was the commercially available zilver ptx stent system, which is a selfexpanding nitinol stent with a polymer free paclitaxel coating 3. The epic stent is a selfexpanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. April 1, 2015 dublin the everflex selfexpanding peripheral stent system from medtronic plc nyse. Everflex selfexpanding peripheral stent with entrust delivery system clinical study the safety and scientific validity of this study is the responsibility of the. Everflex selfexpanding peripheral stent system instructions for use device description the everflex selfexpanding peripheral stent system is a selfexpanding nitinol stent system intended for permanent implantation. Mdt today announced the launch of its entrust delivery system in the united states. The supera and everflex stents buckled at 3cm and 43cm, but for the supera stent, this was associated with significant torque as demonstrated in fig. This postapproval study is designed to confirm the longterm safety and effectiveness of the everflex selfexpanding stent system for the treatment of atherosclerotic superficial femoral artery sfa and proximal popliteal arteries.
The broad size matrix 20 mm 200 mm allows physicians to choose the most appropriate singlestent fit. Everflex post approval study durability pas the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Comparison of femoropopliteal artery stents under axial and. The supera peripheral stent is indicated for the superficial femoral artery sfa and the proximal popliteal artery.
Mar 10, 2020 the everflex selfexpanding stent system was evaluated in a study and proximal popliteal by using the everflex nitlnol stent system ii. Nitinol stent implantation in long superficial femoral artery lesions. The intention of this study was to treat all lesions with as few stents as possible. Mdt has proven to provide sustained patency in the treatment of long, complex lesions in the superficial femoral sfa and popliteal arteries, according to the threeyear results of the durability ii study, which are reported in the recent issue of catheterization and cardiovascular. Each patient receivedatleastone200mmlongstent,andtheinvestigator used as few stents as possible to obtain complete lesion coverage. The everflex selfexpanding peripheral stent system is now indicated for use in the superficial femoral artery sfa andor proximal popliteal artery. For treatment of complex superficial femoral artery lesions, suitable stent devices are required. The set includes a stent, a wire guide, and a stent positioner.
Results of the protege everflex 200mmlong nitinol stent ev3 in tasc c and d femoropopliteal lesions. The everflex selfexpanding peripheral stent system is a selfexpanding nitinol stent system intended for permanent implantation. Stent implantation was performed according to the standard procedures stipulated in the instructions for use available for the protege everflex stent. The primary outcome of this study was the primary patency rate. All stents except the supera could withstand the intersubject mean pa rotation of 26cm experienced in the gardening posture desyatova et al. To evaluate the short and midterm outcomes of the viabahn endoprosthesis with propaten bioactive surface vs. Listing a study does not mean it has been evaluated by the u. Market entry durability i trial europe starts enrollment 5 mm stent and short. Covidien has announced the launch of its everflex selfexpanding peripheral stent with entrust delivery system in australia and new zealand. The entrust delivery system uses the everflex stent, which has been clinically proven to be safe and effective in treating long, complex and highly calcified lesions. Transbrachial access for stenting of femoropopliteal.
The selfexpanding stent is made of a nickel titanium alloy nitinol and comes premounted on a 6 f, 0. View the sourcing details of the buying request titled ev3 stent, including both product specification and requirements for supplier. In our experience, primary stenting with the everflex stent is associated with acceptable clinical and radiologic longterm outcomes. Whenever free movement of the wire tip within the distal vessel lumen was. Covidien, plymouth, mn is a nitinol stent with spiralcell connections that may allow greater flexibility and reduce the incidence of stent fractures. Everflex peripheral stent system related content the voyager pad trial showed patients with symptomatic peripheral artery disease pad who took the blood thinner rivaroxaban with aspirin after undergoing a procedure to treat blocked arteries in the leg had a 15 percent reduction in the risk of major adverse limb and cardiovascular events when. New ev3 prb3508040080 protege everflex selfexpanding.
The everflex selfexpanding peripheral stent system is a selfexpanding nitinol stent system intended for permanent. Everflex whyaluronic acid helps lubricate joints, boosts flexibility, may increase shock absorption and supports healthy cartilage. First clinical experience with the innova versus the protege everflex. The present study details the first longterm results with the long everflex nitinol stent. Published comparisons between selfexpanding stents have been sparse. Everflex hoses are ideally suited for use in applications where high and low temperature, chemical resistance, low coefficient of friction, flexibility, and nonaging characteristics are required.
Randomized trials and registries of superficial femoral. The vici venous stent system is a nitinol selfexpanding stent specifically designed to meet the challenges of venous anatomy. Find this technical manual in the product labeling supplied with each device or. The everflex selfexpanding peripheral stent system everflex stent is a self expanding nitinol stent system intended for permanent implantation. Covidien launches everflex selfexpanding peripheral stent in. Received ce mark for the protege everflex selfexpanding stent system for general use in the peripheral vasculature, including common and external iliac, subclavian and the superficial femoral artery on march 9, 2006 received fda approval on march 18, 2008 for a 5mm protege everflex stent. First clinical experience with the innova versus the protege. The new entrust delivery system enables physicians to place medtronics everflex selfexpanding peripheral stent, while maintaining a low profile and providing the ease of a onehanded device.
The selfexpanding stent is made of a nickel titanium alloy nitinol and comes premounted on a 6f, 0. Oneyear followup after implantation of the everflex nitinol. On october 23, 2006 ev3 announced a worldwide fracturefree guarantee. A total of 158 protege everflex stents were used to treat 100 lesions. Results of the protege everflex 200mmlong nitinol stent ev3 in. A single stent strategy in patients with lifestyle limiting. Everflex selfexpanding peripheral stent with entrust delivery system clinical study the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Covidien launches everflex selfexpanding peripheral stent. Nov 07, 2014 new data from the durability iliac trial confirm the safety and effectiveness of primary stenting with two selfexpanding stent systems for the treatment of symptomatic iliac artery disease. Sirolimus eluting polymer free coronary stent system thanks to the proven polymer free matrix coating, it provides continuous and controlled drug delivery. The everflex selfexpanding peripheral stent system. Everflex peripheral stent from medtronic delivers sustained. The eluvia stent incorporates paclitaxel in a biocompatible fluoropolymer coating to provide sustained and controlled drug release. The testing presented in this report is intended to provide a comparison of 6 mm diameter.
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