Healthcare Industry News: Elan
News Release - November 30, 2015
Boston Scientific Receives FDA Approval And CE Mark For AngioJet(TM) ZelanteDVT(TM) Thrombectomy CatheterCatheter used to treat deep vein thrombosis to be commercialized in U.S. and Europe
MARLBOROUGH, Mass., Nov. 30, 2015 -- (Healthcare Sales & Marketing Network) -- Boston Scientific (BSX) has received United States (U.S.) Food and Drug Administration (FDA) approval and CE Mark for the AngioJet™ ZElanteDVT™ thrombectomy catheter to treat deep vein thrombosis (DVT) in large-diameter upper and lower limb peripheral veins.
The ZElanteDVT catheter is the first AngioJet catheter designed specifically to treat DVT, a challenging condition that may affect up to 2.5 million people in the U.S. and Europe annually, with a majority of cases occurring during or soon after a hospitalization1, 2. Offering four times the thrombus removal power of current market-leading AngioJet catheters, the ZElanteDVT catheter was designed to efficiently remove large venous clot burdens and facilitate rapid restoration of blood flow, potentially decreasing procedural time, quickly relieving symptoms and reducing late complications.
"There has been a clinical need for a stronger thrombectomy catheter to support treatment modalities in addressing challenging cases of deep vein thrombosis," said Mitchell Silver, DO, FACC, Riverside Hospital in Columbus, Ohio. "The unique features of the ZElanteDVT catheter make it well-suited to treat a wide range of thrombotic occlusions thus potentially decreasing bleeding risks and reducing patients' need for intensive care stays."
DVT occurs when a blood clot (or "thrombus") forms in one or more of the deep veins, most often in the legs. Left untreated, DVT can lead to serious and even life-threatening complications. The most serious complication of DVT can occur if part of the clot breaks off and travels through the bloodstream to the lungs, causing a life-threatening blockage called pulmonary embolism (PE). If the clot is not removed, it can also cause permanent damage to the valves in the affected veins, a condition known as post-thrombotic syndrome (PTS). Up to half of all patients with DVT will develop PTS within two years of their diagnosis, causing permanent pain, discomfort and swelling of the affected limb that may require frequent hospital visits3. Early diagnosis and rapid restoration of blood flow may help decrease the risk of these serious complications and reduce the need for future hospitalizations.
"The new features of the ZElanteDVT catheter represent our focus on improving procedural efficiencies and reducing the economic burden associated with this challenging condition," said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. "With this addition to our AngioJet portfolio, we are further evolving the current suite of life-changing therapeutic options available to physicians and their patients with deep vein thrombosis."
About the ZElanteDVT Thrombectomy Set
The ZElanteDVT Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including DVT, from iliofemoral and lower extremity veins greater than or equal to 6.0 mm in diameter, and upper extremity peripheral veins greater than or equal to 6.0 mm in diameter. It is also intended for use with the AngioJet Power Pulse™ technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
About Deep Vein Thrombosis
Deep vein thrombosis (DVT) occurs when a blood clot (or "thrombus") forms in one or more of the deep veins. DVTs can occur anywhere – most often in the legs. Those at the highest risk of developing DVT are older in age, overweight and inactive. Common symptoms of DVT include swelling, pain, tenderness, warm skin and/or discoloration in the affected leg, leg fatigue as well as surface veins can become more visible. Sometimes, no noticeable symptoms occur. The most serious complication of DVT can occur if part of the clot breaks off and travels through the bloodstream to the lungs, causing a blockage called pulmonary embolism (PE). If the clot is large, it can stop blood from reaching the lungs and can be fatal. To treat DVT, doctors may prescribe medications such as blood thinners; or they may perform interventional procedures to remove or break up a clot, place a filter to capture a clot, or other surgical approaches for clot removal.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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1 Gerotziafas GT, et al. Prophylaxis of Venous Thromboembolism in Medical Patients. Curr Opin Pulm Med. 2004; 10:356-365.
2 Cohen AT, et al. Venous Thromboembolism (VTE) in Europe. The Number of VTE Events and Associated Morbidity and Mortality. Thromb Haemost. 2007 Oct;98(4): 756-64.
3 Kahn, SR, et al. Determinants and Time Course of the Postthrombotic Syndrome after Acute Deep Venous Thrombosis. Ann Intern Med. 2008; 149(10): 698-707.
Source: Boston Scientific
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