VANCOUVER, March 13 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. announced today that it has entered into a definitive licensing agreement with privately held Rex Medical, LP (“Rex Medical”) for exclusive worldwide rights to market and distribute the Option(TM) inferior vena cava (IVC) filter, a medical device that is implanted into the body’s inferior vena cava to prevent pulmonary embolism (PE).
According to industry research, the U.S. market for IVC filters in 2007 was approximately $200 million with retrievable filters accounting for approximately two-thirds of this market. The Option(TM) IVC filter, developed by Rex Medical, is an IVC filter specifically designed for long-term retrieval post device implantation and is expected to be approved for both permanent and retrievable indications.
Angiotech and Rex Medical will be exhibiting at the 33rd Annual Meeting of the Society of Interventional Radiology (SIR) to be held in Washington, DC from March 15-18, 2008.
“With product offerings such as the Option(TM) IVC filter and our EnSnare(TM) retrieval device, we are continuing our commitment to offer industry-leading technologies to service the needs of our interventional and endovascular call points. We believe that the Option(TM) IVC filter is a cornerstone technology for our Interventional business and a ‘best-in-class’ product that will be significantly differentiated in the marketplace,” said Dr. William Hunter, President and CEO of Angiotech.
“We are pleased to have entered into this commercial partnership with Angiotech for the Option(TM) IVC filter in such a critical market for the interventional community. We believe that the Option(TM) IVC filter is a superior IVC filter and will significantly improve the clinical management of pulmonary emboli in patients. Clinical data from our international clinical study has shown that the Option(TM) IVC filter can be successfully retrieved in patients for longer than one year. The development of the Option(TM) filter further exemplifies Rex Medical’s commitment to the delivery of ground-breaking medical devices for the interventional community,” said Dr. James F. McGuckin, Co-Founder of Rex Medical.
Rex Medical expects to complete enrolment of its U.S. clinical study for the Option(TM) IVC filter in the treatment of PE by the end of Q2 2008. Rex Medical anticipates that the filing for 510(k) approval with the FDA for the Option(TM) IVC filter will be completed in the near term. Rex Medical has filed for the CE Mark for the Option(TM) IVC filter and is awaiting approval from the European regulatory bodies. Pending regulatory approval, it is expected that the Option(TM) IVC Filter will be available for commercial sale through Angiotech’s Interventional sales force in the U.S. and in the EU by the end of 2008.
“As the Lead Investigator on the Option(TM) IVC Filter clinical trial, I am impressed with the low profile (6Fr OD) delivery system and novel nitinol design. Results to date suggest that it prevents PE as well as any commercially available filter. And despite its remarkable stability, the Option(TM) has been safely and successfully retrieved at long intervals - up to 175 days in the U.S. IDE,” said Dr. Matthew S. Johnson, MD, Professor of Radiology and Surgery at Indiana University School of Medicine/Chief, Vascular and Interventional Radiology, Clarion Health Partners.
The nitinol, Option(TM) IVC Filter, with a low profile 5Fr (6Fr O.D.) delivery system, is designed to be implanted into the inferior vena cava of patients to prevent recurrent PE. The filter is designed with symmetric flared struts to 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. Designed as both a permanent or retrievable IVC filter, the self-centering filter promotes optimal positioning and stability within the inferior vena cava. Its intuitive, easy-to-use design makes the Option(TM) IVC filters’ deployment and retrieval both safe and effective.
About Pulmonary Embolism (PE)
PE is an extremely common and highly lethal condition that is a leading cause of death in all age groups. 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 rarely other foreign material. PE occurs when these clots break loose and embolize to block pulmonary blood vessels in the lungs. PE affects an estimated 600,000 to 1,000,000 people in the US, and its incidence is increasing annually due mainly to the aging population. According to clinical research, if left untreated, PE has a mortality rate of 30% and is a leading cause of in-patient deaths in U.S. hospitals. Emboli dislodgement can be caused by peripheral vascular disease (PVD), severe deep vein thrombosis (DVT), trauma and, prolonged immobilization often following major surgical procedures.
About Angiotech
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,600 dedicated employees in 18 different countries. 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 , please visit www.angiotech.com.
About Rex Medical, LP
Rex Medical, LP, based in Conshohocken, PA, is a privately held medical device company specializing in the development, manufacturing and marketing of minimally invasive medical devices targeted towards the cardiovascular, venous access, endosurgery and oncology markets.
FORWARD-LOOKING STATEMENTS:
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CONTACT: Angiotech Contact: Deirdre Neary, Angiotech Pharmaceuticals, Inc., (604) 222-7056, dneary@angio.com
CONTACT: Angiotech Contact: Deirdre Neary, Angiotech Pharmaceuticals,
Inc., (604) 222-7056, dneary@angio.com
