Angiotech's Option IVC Filter Cleared
June 8, 2009—Angiotech Pharmaceuticals, Inc. (Vancouver, British Columbia, Canada) announced that the US Food and Drug Administration has granted 510(k) marketing clearance for the Option inferior vena cava (IVC) filter for use in both permanent and retrievable indications. Angiotech holds exclusive worldwide rights to market and distribute the Option IVC filter through a license agreement with the device's developer, Rex Medical, LP (Conshohocken, PA).
According to Angiotech, the Option IVC filter is used to prevent recurrent pulmonary embolism (PE). It is designed to be used in both permanent and retrievable indications and has been successfully retrieved at intervals of up to 175 days after implantation in a clinical trial in the United States. The Option IVC filter is specifically designed to facilitate long-term retrieval after device implantation if desired or deemed necessary by the treating physician, and it can be used for pulmonary thromboembolism when anticoagulant therapy is contraindicated, failure of anticoagulant therapy in thromboembolic diseases, emergency treatment after massive PE, and chronic recurrent PE when anticoagulant therapy has failed or is contraindicated. The Option is a nitinol device with a low-profile delivery system. It is designed with struts that direct clot volume into the center of the vessel for maximum dissolution and preservation of blood flow, allowing for capture of clinically significant clot and protection against PE. The self-centering filter facilitates positioning and stability within the IVC.
The company states that at the 2009 Society of Interventional Radiology annual scientific meeting in March, principal investigator Matthew Johnson, MD, presented results from a single-arm, multicenter clinical trial, which enrolled 100 patients with a mean age of 59 years. The trial 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 PE. In the trial, clinical success—defined as successful technical placement 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 36 of 39 (92%) cases in which 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, the company states.