Angiotech Pharmaceuticals, out of Vancouver, British Columbia, just received FDA clearance for the company’s Option™ IVC Filter, a device indicated for prevention of pulmonary emboli. The Option™ is one of those new types of filters that give the surgeon the opportunity to remove the device at a later time.
From the press release:
The Option IVC Filter is used for the prevention of recurrent pulmonary embolism (PE). The device is implanted, typically by interventional radiologists in a minimally invasive procedure, into the body’s inferior vena cava to prevent PE. Option is specifically designed for use as both a permanent or temporary implant (in temporary, or retrievable, indications, a physician may later perform a second surgical procedure to remove the Option IVC Filter if necessary or where mandated clinically).
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.
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 diseases, emergency treatment following massive PE, and chronic recurrent PE when anticoagulant therapy has failed or is contraindicated. The nitinol, Option™ IVC Filter, with a low profile delivery system, is designed with struts which 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 selfcentering filter facilitates optimal positioning and stability within the inferior vena cava.
Press release: ANGIOTECH PHARMACEUTICALS ANNOUNCES FDA 510(K) CLEARANCE OF THE OPTION™ INFERIOR VENA CAVA FILTER…
Reprinted with permission of Angiotech Pharmaceuticals, Inc
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