Merit Medical Gets FDA OK for Endovascular Snare System
Posted on December 11, 2012 @ 01:49 pm
South Jordan, Utah-based disposable device maker Merit Medical Systems Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its One Snare endovascular system.
The system is a single-loop snare, as opposed to Merit’s En Snare product that has three interlaced loops and is designed to accurately and effectively manipulate and retrieve foreign bodies from blood vessels.
“This FDA clearance will provide customers the opportunity to buy the single-loop One Snare or the triple-loop En Snare, both of which have distinct clinical uses and benefits,” said Fred P. Lampropoulos, Merit’s chairman and CEO. “We believe we are the only company offering this combination of products.”
According to the company, the One Snare can be used to retrieve inferior vena cava filters, reposition indwelling venous catheters, strip fibrin sheath formation, or assist in central venal access venipuncture. The device is made from Nitinol, which reportedly provides flexibility and kink resistance. Gold-plated tungsten is wrapped around the Nitinol loop to aid in visualization under fluoroscopy. The One Snare is available in multiple configurations to provide retrieval options within a variety of vessel sizes.
Merit Medical Systems develops disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology, and endoscopy.
Photo of One Snare endovascular system courtesy of Merit Medical Systems.
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