Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter
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.
According to market analysis conducted by Millennium Research Group, the U.S. market for IVC filters was approximately
The results of a recently concluded clinical trial for the Option IVC Filter were presented by the study’s Principle Investigator, Dr.
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.
Forward Looking Statements --------------------------
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Given these uncertainties, assumptions and risk factors, readers are cautioned not to place undue reliance on such forward-looking statements. Except as required by law, we disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained in this press release to reflect future results, events or developments.
About Angiotech Pharmaceuticals
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech (NASDAQ: ANPI, TSX: ANP), please visit our website at www.angiotech.com.
About Rex Medical, LP
Rex Medical, LP, based in
Option(TM) is a trademark of Rex Medical, LP, used under license by Angiotech.
SOURCE Angiotech Pharmaceuticals, Inc.