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.
Financial terms of the agreement were not disclosed.
About the Option(TM) Inferior Vena Cava Filter
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
|SOURCE Angiotech Pharmaceuticals, Inc.|
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