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 Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPI)(TSX:ANP) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Option(TM) Inferior Vena Cava (IVC) Filter in the United States, for use in both permanent and retrievable indications. Angiotech holds exclusive worldwide rights to market and distribute the Option IVC Filter, which it obtained in a license agreement with privately held Rex Medical, LP (Rex Medical), as previously announced in March 2008.
News about the implantable device to prevent pulmonary embolism sent its shares up Monday morning. The device will be sold in the United States for use in both permanent and retrievable indications. Pulmonary embolism occurs when there is a sudden blockage in a lung artery.
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).
"This important FDA clearance of the Option IVC Filter continues Angiotech's mission of offering the most highly innovative technology solutions to our physician customers and their patients," said Dr. William Hunter, President and CEO of Angiotech. "We are excited to commence commercial sales of Option through our dedicated Interventional Sales Team in the very near future. We believe the flexibility to use the Option IVC Filter in both permanent and retrievable indications, with clinical study data indicating 92% retrieval success, and a retrieval at up to 175 days post-implantation, provides Option the opportunity to be the market leading product in PE prevention."
According to market analysis conducted by Millennium Research Group, the U.S. market for IVC filters was approximately $200 million in 2007 (with approximately 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 diseases, emergency treatment following massive PE, and chronic recurrent PE when anticoagulant therapy has failed or is contraindicated. The nitinol, Option(TM) 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 self-centering filter facilitates optimal positioning and stability within the inferior vena cava.
About Pulmonary Embolism (PE)
PE is an extremely common and highly lethal condition. PE is the sudden blocking of an artery of the lung (pulmonary artery) by a collection of solid material brought through the bloodstream (embolus) - usually a blood clot (thrombus) or other foreign material. PE occurs when these clots break loose and "embolize" to block pulmonary blood vessels in the lungs. According to clinical research, if left untreated, PE has a mortality rate of 30%. Emboli dislodgement can be caused by peripheral vascular disease (PVD), severe deep vein thrombosis (DVT), trauma and, prolonged immobilization often following a major surgical procedure.
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