Everflex selfexpanding peripheral stent with entrust delivery system clinical study the safety and scientific validity of this study is the responsibility of the. The selfexpanding stent is made of a nickel titanium alloy nitinol and comes premounted on a 6 f, 0. The bpses has an abluminal coating with a matrix containing sirolimus and poly dllactideco. Finally, 4 and 12 weeks after the stent with adc implanted into rabbit carotid arteries, it showed that the stent with adc was safe and could effectively prevent thrombosis and in. The everflex selfexpanding peripheral stent system is now indicated for use in the superficial femoral artery sfa andor proximal popliteal artery.
Everflex selfexpanding peripheral stent system ordering. The selfexpanding stent is made of a nickel titanium alloy nitinol and comes premounted on a 6f, 0. A survey of stent designs university of southampton. Initial clinical experience with the protege everflex long. In ev3s rigorous simulated fatigue testing, the protege everflex survived significantly longer than any competitive stent tested.
Between february and march 2006 a total of 15 everflex nitinol stents were implanted in 12 patients with either total sfa occlusions. Market entry durability i trial europe starts enrollment 5 mm stent and short. Biflex stents 3 offer a new main route that dif fers from the described wellknown balloon expandable and selfexpanding stent types, as summarised in t able 1. The dpees is an everolimuseluting stent with a uniform coating of durable fluoropolymer. The everflex selfexpanding peripheral stent system is a selfexpanding nitinol stent system intended for permanent implantation. Everflex whyaluronic acid helps lubricate joints, boosts flexibility, may increase shock absorption and supports healthy cartilage. The everflex selfexpanding peripheral stent system has received fda approval for the treatment of atherosclerosis in the iliac arteries. Medtronic launches the entrust delivery system in the united. The fully covered stent may be reconstrained up to 75% of deployment and 2 times during the initial stent placement. Listing a study does not mean it has been evaluated by the u. The stent itself was mounted on a balloon and could be opened once inside the coronary artery. The endeavor stent was designed as a synthesis of the best available medical, material, pharmaceutical and manufacturing technology. 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.
Medtronic launches the entrust delivery system in the. Mdt today announced the launch of its entrust delivery system in the united states. Results of the protege everflex 200mmlong nitinol stent. 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. New ev3 prb3508040080 protege everflex selfexpanding. The everflex selfexpanding peripheral stent with entrust delivery system is intended to improve luminal diameter in the treatment of symptomatic denovo or restenotic lesions up to 140 mm in length in the native superficial femoral artery sfa andor proximal popliteal arteries with reference vessel diameters ranging from 4. 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.
The powerflex pro pta catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Ultra thin stent struts for ultra large lumen gain. The broad size matrix 20 mm 200 mm allows physicians to choose the most appropriate singlestent fit. Safety and effectiveness study of everflex stent to treat. The everflex selfexpanding peripheral stent system everflex stent is a selfexpanding nitinol stent system intended for permanent implantation. The intention of this study was to treat all lesions with as few stents as possible.
April 1, 2015 dublin the everflex selfexpanding peripheral stent system from medtronic plc nyse. In addition to the new indication, it is now available in a 200 mm length. Members receive wholesale pricing up to 33% off nonmember cost and other benefits. 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. Flexible slink provides unparalleled flexibility, deliverability and vessel conformability allowing you to deal with the most complicated anatomies. Baremetal biliary stent a sterile nonbioabsorbable tubular device intended to be implanted in an obstructed biliary duct e.
Welcome to the online edition of endovascular today 2012 buyer guide. Intended for palliation of malignant neoplasms in the biliary tree. Fully connected durable solution superior fracture resistance2 cordis s. Stent size fr stent length cm wire guide diameter inch more info. The stent is preloaded on the stent delivery wire and protected by an introducer sheath. In 1986, working in toulouse, france, jacques puel and ulrich sigwart inserted the first stent into a human coronary. Stent placement accuracy the coaxial delivery system is designed to result in 1. Product line ccode ccode description unspsc code unspsc code description mo. Covidien launches everflex selfexpanding peripheral stent in. With a press of the plunger, the stent will be loaded into the tube.
The charts include sizes, configurations, and unique characteristics of each product, listed alphabetically by manufacturer name. 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. Sirolimus eluting polymerfree coronary stent system. Oct 27, 2014 the everflex selfexpanding peripheral stent system has received fda approval for the treatment of atherosclerosis in the iliac arteries. Boston scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The stent is cut from a nitinol tube in an open lattice design, and has. First clinical experience with the innova versus the protege everflex selfexpanding bare metal stents in superficial femoral artery occlusions. A stent is a small metal mesh tube that will remain in pace permanently to help keep the selected blood vessel open stents are a permanent addition to your vasculature, and the tissue lining the arteries will actually grow over the metal mesh to cover the inner lumen of the stent. The stent loader along with a folded and welllubricated stent is placed into the distal end of the tracheoscope tube. This buyer guide offers a searchable, comprehensive listing of the fdaapproved interventional devices available in the united states. Indications, contraindications, warnings and instructions. The stent delivery wire comes in two configurations. A survey of stent designs 9 additions of molybdenum and niobium.
Jul 06, 2018 baremetal biliary stent a sterile nonbioabsorbable tubular device intended to be implanted in an obstructed biliary duct e. 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. Zilver flex vascular selfexpanding stent cook medical. First clinical experience with the innova versus the protege. In its fully annealed condition, stainless steel is easily deformable and, therefore, the standard material for balloonexpandable stents. Product line ccode ccode description unspsc code unspsc. The endoscopic transition zone is designed to aid in stent placement accuracy when deployed using endoscopic visualization. Safety and effectiveness study of everflex stent to treat symptomatic femoralpopliteal atherosclerosis durability ii the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Treat lesions in either the sfa, proximal popliteal, or common andor external iliac arteries with confidence, knowing that the durability trial series demonstrated safety and efficacy of.
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. Catalogue cardiology your partner for coronary angioplasty. Choose the everflex selfexpanding peripheral stent system for its combined benefits of durability and deployment accuracyall in a broad range of sizes. Everflex peripheral stent from medtronic delivers sustained. Covidien has announced the launch of its everflex selfexpanding peripheral stent with entrust delivery system in australia and new zealand. Indications, contraindications, warnings and instructions for use can be found in the labeling supplied with each product. 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. 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. Cobaltchromium bare metal stent with ultra thin struts for small vessel diseases. This product line is serviced by the following clinical divisions. Ma ultra c1884 embolizaton protective system none nanocross c1725 catheter, transluminal angioplasty, nonlaser may include infusionperfusion capability 42203405 angioplasty balloon catheter nanocross elite c1725 catheter, transluminal angioplasty, nonlaser may include infusionperfusion capability. Clinical results following stent implantation in the superficial femoral artery sfa are limited due to restenosis, often caused by stent fractures. In its fullhard condition, on the other hand, it exhibits enough elasticity for certain selfexpanding stent designs. Nitinol stent implantation in long superficial femoral artery lesions. It may be a mesh structure or a continuous tube and is made entirely of metal e. The present study details our initial experience with the routine use of the novel protege everflex long selfexpanding nitinol stent for. Fda approves peripheral stent system for iliac disease.
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. Starcut tube laser cutting machine highprecision laser tube cutting system, cohr starcuttubefamily brochure 0318. This is a multicenter, nonrandomized, single arm study to compare pta and primary stenting using a single protege everflex stent to performance goals of pta alone in the treatment of atherosclerotic superficial femoral artery sfa and proximal popliteal lesions. Supraflex has the lowest strut 60m thickness among all the available sirolimus eluting coronary stents, without compromising radial strength.
Julio palmaz and richard schatz were working on such a stent in the united states. Veriflex baremetal coronary stent system is a product of boston scientific corporation. 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. First clinical experience with the innova versus the. 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. Everflex selfexpanding peripheral stent with entrust. Ultraflex singleuse covered esophageal ng stent system proximal release order number stent. Peripheral and biliary stents vascular stenting medtronic.
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