Healthcare Industry News:  cell therapy 

Devices Interventional FDA

 News Release - July 30, 2007

Cook Medical Receives FDA Clearance for Celect(TM) Vena Cava Filter

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical, already a proven leader in the IVC filter market, has received clearance from the U.S. Food and Drug Administration (FDA) for a permanent indication for its newest vena cava filter. Cook has developed the latest medical advancement in pulmonary embolism (PE) prevention - the Celect(TM) Vena Cava Filter.


"Building on the successes of Cook's earlier Bird's Nest and Gunther Tulip vena cava filters, the Cook Celect filter offers physicians a new choice for minimizing the risk of blood clots and pulmonary embolism in their patients," said Rob Lyles, global leader of Cook Medical's Peripheral Intervention products division. "All of us at Cook Medical are extremely pleased to offer this product and the improvement in patient care it can bring to physicians and patients in the U.S."

The Celect filter is an implanted expandable metal device used to capture hazardous blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. The Celect filter employs a conical shape with a unique strut design that improves centering in the vessel and reduces in-growth except at the desired end points.

The Celect filter is currently cleared for permanent placement in patients in the U.S. In 2006, the Celect filter was approved for permanent and retrieval indications in Canada, Australia and Europe. Trials are currently being conducted with the Celect filter to study other aspects of the device, including retrievability.

"Cook's continuing goal is to improve the lives of patients by constantly offering them state-of-the-art technology in our products. The Celect is a great example of putting that philosophy into practice," added Lyles.

About Cook Medical

Cook Medical was among the first companies to introduce interventional devices in the United States. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook won the prestigious Medical Device Manufacturer of the Year Award for 2006 from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.


Source: Cook Medical

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