Healthcare Industry News:  Cook 

Devices FDA

 News Release - March 19, 2008

Cook Medical Receives FDA 510(k) Clearance for Celect(TM) Vena Cava Filter and Gunther Tulip(TM) Vena Cava Filter Retrieval Set

Clearance Provides More Options for Prevention of Recurrent Pulmonary Embolism

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical, a global leader in the implantable vena cava (IVC) filter market, was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Celect™ Vena Cava Filter. Cook’s Celect Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava and now can be optionally retrieved when clinically indicated.

According to the National Heart Lung and Blood institute, PE is caused by a blockage in a lung artery, and often times is a complication of a condition called deep vein thrombosis (DVT). In DVT, blood clots form in deep veins that can break free and travel to the lung. Each year, at least 100,000 cases of PE occur in the United States and the condition is recognized as the third most common cause of death in hospitalized patients. If left untreated, about 30 percent of patients with PE will not survive and most within the first few hours of the blockage.1

“Receiving an additional indication for retrievability further solidifies Cook’s position as a world authority on IVC filtration and PE prevention,” said Rob Lyles, global vice president and global leader of Cook Medical’s Peripheral Intervention products division. “Our goal at Cook Medical has been to provide more options to prevent this extremely serious condition. With our Bird’s Nest™ permanent filter, the Günther Tulip™ optional filter, and now the newest Celect Filter, we offer physicians a full range of options to treat patients at risk for PE.”

The Celect filter is an implanted 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. Employing a conical shape, the Celect filter has a unique strut design that improves centering in the vessel and reduces in-growth except at the desired attachment points. The Celect filter was cleared for permanent placement in the U.S in 2007. In 2006, the Celect filter was approved for permanent and retrieval indications in Canada, Australia and Europe.

The Günther Tulip Vena Cava Filter was first approved for use in Europe in 1992, and received FDA clearance in October 2000 for permanent placement and in October 2003 for retrievable use. The Günther Tulip is the world’s leading-selling optional filter.

About Cook Medical

Cook Medical was one of the first companies to introduce interventional devices in the United States. Today, the company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes. Cook won the prestigious Medical Device Manufacturer of the Year from Medical Device and Diagnostic Industry magazine. For more information, visit www.Cookmedical.com.

1 http://www.nhlbi.nih.gov/health/dci/Diseases/pe/pe_what.html


Source: Cook Medical

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