Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena C...(tely 160000 IVC filters implanted). This...)

Date:6/8/2009

tely 160,000 IVC filters implanted). This market is predicted to grow to $300 million by 2012. IVC filters can be permanent or retrievable (where a physician can remove them when the patients no longer require them). Retrievable filters accounted for approximately two-thirds of the market in 2007. The Option IVC Filter is designed to be used in both permanent and retrievable indications and has been successfully retrieved at long intervals - up to 175 days post-implantation in the U.S. clinical trial.

The results of a recently concluded clinical trial for the Option IVC Filter were presented by the study's Principle Investigator, Dr. Matthew Johnson, at the 34th Annual Scientific Meeting of the Society of Interventional Radiology in March of 2009. The single-arm, multicenter clinical trial, which enrolled 100 patients with a mean age of 59 years, was designed to evaluate the safety and efficacy of the Option IVC filter when used both as a permanent and temporary filter in patients at increased risk for pulmonary embolism. In the trial, clinical success, defined as placement technical success without subsequent PE, significant filter migration or embolization, symptomatic thrombosis or other complications requiring filter removal or intervention, was achieved in 88% of subjects. Retrieval success was achieved in 92% (36/39) of cases where retrieval was attempted, with a mean implantation time in those cases of 67 days. The safety profile of the Option IVC Filter was consistent with other currently marketed IVC filters.

About the Option(TM) Inferior Vena Cava Filter

The Option IVC filter, developed by Rex Medical, is specifically designed to facilitate long-term retrieval post device implantation if desired or deemed necessary by the treating physician, and can be used in the following conditions: pulmonary thromboembolism when anticoagulant therapy is contraindicated, failure of anticoagulant therapy in thromboembolic disease
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SOURCE Angiotech Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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