Pdf palliative treatment of superior vena cava syndrome. Opencell stents have incomplete connections between the stent struts that increase the stents flexibility, and they can be used in vessel segments with extensive carotid bifurcation angulation or tortuosity. We describe a case of a 67yearold gentleman with metastatic gastric neuroendocrine tumour. Incidence 1 300,000 new dvts per annum in europe say iliofemoral 100,000 if dvts p. 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. The purpose of this study was to evaluate a single quaternary centres early and midterm outcomes following endovascular reconstruction of the axillosubclavian vein using dedicated venous stents in patients. Luminal diameter improvement at procedure greater than 100% improvement by site. Iatrogenic occlusion of bilateral jugular veins, subclavian.
Zilver vena venous selfexpanding stent nitinol 7 0. Selfexpanding stents for cas include two main types. Complex iliocaval reconstruction with selfexpending nitinol stents. Polymerfree paclitaxelcoated zilver ptx stentsevaluation of pharmacokinetics and comparative safety in porcine arteries. Ultrasound accelerated catheter directed thrombolysis uacdt is used for acute occlusions in the arterial system, deep vein thrombosis dvt, and pulmonary embolism. Self expanding stent an overview sciencedirect topics. This is an open access article which appeared in a journal. Cooks zilver ptx drugeluting stent for peripheral disease. Used in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Nov 15, 2012 the fda today approved cook medicals zilver ptx stent. S selfexpanding stents company name product name material used introducer size f. Stent deployment is controlled by retraction of the handle while holding the metal cannula stationary. 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. 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. 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. Vascular response after zilver ptx stent implantation for. Stent in the treatment of symptomatic iliofemoral venous outflow obstruction. Palliative treatment of superior vena cava syndrome with nitinol stents. An arnoldchiari malformation is a congenital central nervous system defect. Fda approves zilver ptx drugeluting stent for peripheral. Zilver vena was developed to address a challenging clinical issue, the need to establish and maintain blood flow in obstructed iliofemoral veins.
Zilver vena venous selfexpanding stent cook medical. Outcomes of endovascular reconstruction of the inferior vena cava with selfexpanding nitinol stents. Cook medicals zilver stent approved for vascular use in canada. Possible advantages of uacdt over the use of a normal thrombolysis catheter are shortened. Ivc filter lawsuits arise from the high failure rate and severe injuries the ring of fire duration.
Between december 2004 and may 2011, 78 consecutive patients 54 men and 24 women with a mean age of 64. Zilver vena venous selfexpanding stent product status. Cook medicals zilver biliary stent is the first stent of its kind made of flexible lasercut nitinol tubing. It is very precise, shows zero foreshortening, has 30% higher radial force than the cook zilver, and the results of the vivo eu study have been encouraging. Demographic, procedural, and followup data of 12 patients seven women. The zilver vena stent appeared to be safe, easy to deploy, and showed good clinical. Zilver stent cook, bloomingdale, in, usa to revascularise the occludediliac vein alongwith the adjunctsofsplit skingrafting to the ulcer and long term bilateral compressiontherapy. Optimed, the vici boston scientific, the abre medtronic, and zilver vena cook stents. It is the first drugeluting stent des approved for the treatment of peripheral arterial disease pad in the superficial femoral and. The optimal method to treat any residual venous scarring however remains unclear. The fda today approved cook medicals zilver ptx stent. As the only device of its kind available in canada, zilver vena gives physicians a new treatment option for stenting diseased veins.
Cooks zilver vascular stent is indicated for use in the treatment of symptomatic vascular disease of the iliac arteries with a reference vessel diameter of 6 mm or larger. Oneyear results of the vivoeu study showed treatment with the zilver vena venous selfexpanding stent resulted in 87. Built on cooks established line of zilver stents, the zilver vena stent is a flexible, selfexpanding stent made with shape memory nitinol. Patients involved in the study will be followed after their procedure to monitor complication rates and improvement of symptoms. Vivoeu is the worlds first prospective, nonrandomized, multicenter study of a venous stent in the treatment of symptomatic iliofemoral outflow obstruction. The stent may be used to treat lesions up to 100 mm in length, according to the approved indications. Cook medical launches zilver vena venous selfexpanding stent. Intended for improvement of luminal diameter in the treatment of symptomatic iliofemoral outflow obstruction. Intended for improvement of luminal diameter in the treatment of symptomatic iliofemoral outflow obstruction purpose. Midterm results of a novel dedicated venous stent for the. B the cook zilver vena venous stent has an open cell design. Patency and clinical outcomes of a dedicated, selfexpanding. Overview of zilver venatm venous stent in the treatment of.
Biba medical, europe 526 fulham road, fulham, london, sw6 5nr tel. A the boston scientific wallstent endoprosthesis has an elgiloy braided construction. Zilver vena is currently available in 14 and 16 mm diameters and 60, 100 and 140 mm lengths to enable precise placement, and is compatible with 7 fr sheaths and 9 fr guiding catheters. It was concluded that the stent treatment for superior vena cava syndrome is a safe. Endovascular recanalisation of chronic iliofemoral obstructions. Diagnosis and management of right external iliac vein. Surgical venous bypass is an effective treatment option in the management of benign superior vena caval obstruction. Patients should be suitable candidates for pta andor stent treatment.
A variety of nitinol stents were placed, the most common being the zilver vena 30% cook medical, bloomington. Iliocaval obstruction is a substantial contributor to chronic venous insufficiency and is increasingly being treated endovascularly with angioplasty and stent placement. Phlegmasia cerulean dolens pcd is an uncommon and severe manifestation of massive proximal venous thrombosis of the lower extremities associated with a high degree of morbidity and mortality. Zilver vena selfexpanding venous stent preliminary european. Stented cormatrix conduit to bypass benign superior vena. Evaluation of the zilver vena venous stent vivo eu the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Aug 30, 2017 surgical venous bypass is an effective treatment option in the management of benign superior vena caval obstruction. Cooks zilver biliary stent compares favorably to boston sci.
The study has reached full enrolment, with final followup anticipated in summer. Double chimney technique using interwoven selfexpanding. Endovascular treatment in a case of phelgmasia cerulean doleans a b s t r a c t. Endovascular stent placement for chronic postthrombotic. Evaluation of the zilver vena venous stent full text view. Shortterm clinical experience with a dedicated venous. We describe a patient with iatrogenic occlusion of bilateral jugular veins, subclavian vein, and superior vena cava resulting from repeated central venous cannulations. Cook medical launches zilver vena venous selfexpanding stent in canada bloomington, ind. Zilver vena selfexpanding venous stent preliminary. Identifying the dominant inflow by ivus is probably the key step to this case 6. The aim of the study was to assess the early clinical experience with the zilver vena stent in treating patients with malignant superior vena cava syndrome.
Surgical management of venous thoracic outlet syndrome vtos is based upon resection of the first rib. Treatment of symptomatic iliofemoral venous outflow obstruction stent diameters 14 and 16 mm stent lengths 60, 100, and 140 mm us caution. The purpose of this study was to evaluate a single quaternary centres early and midterm outcomes following endovascular reconstruction of the axillosubclavian vein using dedicated venous. Initial clinical experience article pdf available in the journal of cardiovascular surgery 566 july 2015 with 7 reads. Pdf a new nitinol stent for use in superior vena cava. Evaluation of the zilver vena venous stent full text. View or download all content the institution has subscribed to. Unlike many studies of iliofemoral venous stent placement, short and longterm patient outcomes are reported herein according to cause, ie, iliac vein compression syndrome, acute deep vein thrombosis, and chronic postthrombotic occlusion. Article information, pdf download for double chimney technique. D, after 2 days of catheterdirected thrombosis in addition to mechanical thrombectomy using the angiojet solent omni catheter, there is a significant reduction in the volume of clot in the right proximal femoral veindistal external. Raised intracranial pressure is commonly observed, and posterior decompression neurosurgery is the treatment of choice. Cook medical launches zilver vena venous selfexpanding.
The stent is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The zilver ptx drugeluting peripheral stent is intended. This is the first metaanalysis of stent placement for the treatment of iliofemoral venous outflow obstruction. Early data from venous stent trials very promising cx. Following health canada approval, cook medical made the zilver vena venous selfexpanding stent available to physicians across canada at the 2012 annual. August 10, 20 cook medical of bloomington, indiana is once again shipping its zilver ptx drugeluting stent for use in treating peripheral artery disease. A new nitinol stent for use in superior vena cava syndrome. Jan 28, 2016 the cook zilver vena is an opencell, lasercut nitinol, selfexpanding stent on a 6f0. Pdf palliative treatment of superior vena cava syndrome with. A comparison of stent strut thickness between the orsiro stent, pictured, and the marketleading stents on the u. Use of anticoagulation therapy post deep venous stenting for. Nitinol, which is inherently kinkresistant, allows zilver to conform to the ductal.
Safety and effectiveness of stent placement for iliofemoral. Zilver vena venous stent has been commercially available in europe since 2010. Jul 18, 2019 surgical management of venous thoracic outlet syndrome vtos is based upon resection of the first rib. Evaluation of the zilver vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
We analyzed the radial resistive force, the chronic outward force, as well as the crush. Mar 05, 2007 cooks zilver vascular stent is indicated for use in the treatment of symptomatic vascular disease of the iliac arteries with a reference vessel diameter of 6 mm or larger. Biba medical, europe 526 fulham road, fulham, london, sw6 5nr. Indications for use the zilver vascular stent is intended for use as an adjunct to percutaneous. Endovascular treatment in a case of phelgmasia cerulean. The company reports that the fda has approved their fix of the catheter tip separation problem that prompted cooks voluntary recall in april, followed by an fda class i recall a month later. The anatomical positions of the right common iliac artery, inferior vena cava ivc, and.
As the only device of its kind available in canada, zilver vena gives physicians a new. C the boston scientific veniti vici venous stent has a closed cell design. Different test methods may yield different results. Linc 2018 live case guide leipzig interventional course. 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. Utilization of an appropriate stent for treatment is pivotal. This product line is serviced by the following clinical divisions.
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