Fda approves zilver ptx drugeluting stent for peripheral. This is an open access article which appeared in a journal. The study is designed as a single arm nonrandomized postapproval study. Where available, mr safety information can be found on each product specification page on the cook medical website. Cook zilver vena n3 this product is not available for sale in the us. Around 5% of the patients younger than 30 years with. It looks like youre using an obsolete version of internet explorer. Zilver 635 vascular selfexpanding stent cook medical. Interim results from the prospective study of the zilver vena venous. Inferior vena cava agenesis ivca is one of the many anomalies of this vessel. Cook medicals zilver vena venous selfexpanding stent trial is a first for the u.
S selfexpanding stents company name product name material used introducer size f endhole inch stent diameter mm stent length mm delivery system length cm ce mark indications. The study has reached full enrolment, with final followup anticipated in summer. Boston wallstent optimed cook zilver vena veniti vici optimed sinus obliquus bard venovo vivo eu trial virtus trial vernaculartrial sinus obliquus01nis upcoming. Built on cooks established line of zilver stents, the zilver vena stent is a flexible, selfexpanding stent made withshape memory nitinol. Vivo trial will evaluate cooks zilver vena stent to treat. Event free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention bypass or amputation of toe, foot or leg, surgical repair of the target vessel e. Zilver ptx drugeluting peripheral stent cook medical. Stent in the treatment of symptomatic iliofemoral venous outflow obstruction. Pdf clinical features and management of superior vena. April 16, 20 cook medical announced the launch of a new clinical study, the first of its kind evaluating the safety and effectiveness of its zilver vena venous selfexpanding stent. The zilver vena stent appeared to be safe, easy to. Trusted by finance, loved by business vena solutions.
Vivoeu is the worlds first prospective, nonrandomized, multicenter study of a venous stent in the treatment of symptomatic iliofemoral outflow obstruction. Patients involved in the study will be followed after their procedure to monitor complication rates and improvement of symptoms. Designed to restore blood flow in obstructed iliofemoral veins, zilver vena provides physicians with a tool designed specifically for stenting obstructed. Intended for improvement of luminal diameter in the treatment of symptomatic iliofemoral outflow obstruction purpose. Evaluation of the zilver vena venous stent vivo eu is a prospective, nonrandomised, multicentre study intended to evaluate the zilver vena stent in the treatment of symptomatic iliofemoral venous outflow obstruction. Palliative treatment of superior vena cava syndrome with. Vivoeu is the worlds first prospective, nonrandomized, multicenter study of a venous stent in the treatment of symptomatic iliofemoral. Trial n year stent manufacturer ptsnivl findings prospective study design comparative rct osullivan etal 20 20 zilver vena cook 70.
Evaluation of the zilver ptx drugeluting stent in the. Home cook medicals zilver vena venous selfexpanding stent trial is a 1st. Initial clinical experience article pdf available in the journal of cardiovascular surgery 566 july 2015 with 7 reads. The purpose of the vivo clinical study is to evaluate the safety and effectiveness of the zilver vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction. Different test methods may yield different results. Zilver vena was developed to address a challenging clinical issue, the need to establish and maintain blood flow in obstructed iliofemoral veins. The zilver vena stent is designed for iliofemoral venous stenting, and is. Article information, pdf download for double chimney technique. Cook medical launches zilver vena venous selfexpanding. Used in the iliac, superficial femoral artery sfa and abovetheknee popliteal artery for the following treatments.
Percutaneous endovascular ystenting of a malignant superior vena cava and innominate vein obstruction. It is one of the most uncommon anomalies, with an estimated prevalence of 0. Zilver vena venous selfexpanding stent nitinol 7 0. Intended for improvement of luminal diameter in the treatment of symptomatic iliofemoral outflow obstruction the zilver vena venous stent is intended for the treatment of. Flexibility and kink resistance of proven zilver technology. Cook medicals zilver vena venous selfexpanding stent trial is a 1st. Evaluation of the zilver vena venous stent vivo eu is a prospective, nonrandomized, multicentre study intended to evaluate the zilver vena stent in the treatment of symptomatic iliofemoral venous outflow obstruction. The zilver vena venous stent, ce marked in 2010, is a selfexpanding nitinol stent available in 14 and 16mm diameters and 60, 100, and 140mm lengths. Zilver vena venous selfexpanding stent evaluation of the zilver vena venous stent 52 table 75. Cook zilver vena 14x100 n2 m nmm radial resistive force 0,00 0,50 1,00 1,50 2,00 2,50 3,00 bard venovo 14x160 n20 optimed sinus venous 14x80 n3 cook zilver vena 14x100 n3 crush resistance bench testing may not be indicative of clinical performance. Patients should be suitable candidates for pta andor stent treatment. Pdf a new nitinol stent for use in superior vena cava. Zilver vena venous selfexpanding stent cook medical. Pdf palliative treatment of superior vena cava syndrome.
Listing a study does not mean it has been evaluated by the u. The zilver vascular stent is intended for use as an adjunct to percutaneous transluminal angioplasty pta in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 9 mm. We employed a kissing stent technique similar to that used to treat aortic. It is the first drugeluting stent des approved for the treatment of peripheral. Cook medical has completed enrolment in the first clinical study of an iliofemoral venous stent conducted in the usa under an fdaapproved investigational device. A new nitinol stent for use in superior vena cava syndrome.
Venovo and vici or pending approval zilver vena and abre. The high radial force of the stent might be of advantage in these patients with expanding masses around the superior vena cava. Pdf percutaneous endovascular ystenting of a malignant. Following health canada approval, cook medical announced the canadian launch of the zilver vena venous selfexpanding stent at the 2012 annual meeting of the canadian society for vascular surgery. Palliative treatment of superior vena cava syndrome with nitinol. With vena, finance teams have cut cycle times by 75% and reporting times by up to 99%.
Any restrictions on use, including any restrictions on further. The zilver vena venous stent is intended for the treatment of symptomatic iliofemoral venous outflow obstruction. The zilver vena stent appeared to be safe, easy to deploy, and showed good clinical outcome. Cook medical adheres to the mr magnetic resonance safety terminology defined in astm international standard practice f2503. Overview of zilver venatm venous stent in the treatment of. Zilver 635 vascular selfexpanding stent used as an adjunct to percutaneous transluminal angioplasty pta in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm.
This prospective, multicenter study enrolled 35 patients 77. Zilver vena venous selfexpanding stent evaluation of the zilver vena venous stent in the treatment of. The stent is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. Treatment of symptomatic iliofemoral venous outflow obstruction stent diameters 14 and 16 mm stent lengths 60, 100, and 140 mm us caution. This article is free for everyone to access, download and read. According to cook medical, the zilver vena venous selfexpanding stent is the worlds firstever stent designed to specifically treat symptomatic iliofemoral venous outflow obstruction. Cook zilver vena longer bigger maintains radial expansile force over its whole length about 12 patients per week. Early data from venous stent trials very promising cx. October 8, 2012 following health canada approval, cook medical made the zilver vena venous selfexpanding stent available to physicians across canada at the 2012 annual meeting of the canadian society for vascular surgery. Matching the right venous stent to your patient and their. It was concluded that the stent treatment for superior vena cava syndrome is a safe treatment with good clinical effect in patients with superior vena cava syndrome in the terminal phase of malignant disease.
Zilver vena selfexpanding venous stent preliminary. Gerard osullivan, department of radiology, university hospital galway, ireland, presented the results of the vivoeu prospective study of the zilver vena venous stent cook medical in the treatment of symptomatic iliofemoral outflow obstruction at the cardiovascular and interventional radiological society of europe annual meeting cirse. Demographic, procedural, and followup data of 12 patients seven women. The eluvia drugeluting vascular stent system boston scientific shows superior primary patency compared to the zilver ptx drugeluting stent cook medical, concludes the 12month. Interim results from the prospective study of the zilver. Tips and tricks in venous stenting gerry osullivan galway,ie. Double chimney technique using interwoven selfexpanding. The purpose of the cook vivo study is to evaluate the safety and effectiveness of the zilver vena venous stent in the treatment of patients with symptomatic.
Radiation free and getting much faster easier to miss calcification on mr. Good clinical effect with resolution of superior vena cava syndrome was achieved in 11 of the 12 patients 92%. Oneyear results of the vivoeu study showed treatment with the zilver vena venous selfexpanding stent resulted in 87. Zilver vena venous stent placement resulted in a greater than 100% luminal diameter improvement immediately postprocedure based on interim analysis, venous clinical symptoms improved following treatment, suggesting that the stent is beneficial to patients major adverse events days postprocedure.
Medtronic, gore, ab medica, intact, abbott vascular. The fda today approved cook medicals zilver ptx stent. Which medical device expert independent opinion home videos about editorial board authors manufacturer info register free. April 11, 20cook medical bloomington, in announced the launch of the vivo clinical research study to evaluate the safety and effectiveness of the zilver vena venous selfexpanding stent in the treatment of symptomatic iliofemoral venous outflow obstruction. Internet explorer is no longer supported by microsoft since the end of 2015. Cook medicals zilver vena venous selfexpanding stent.
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