A Medical Device Daily
Angiotech Pharmaceuticals (Vancouver) reported it has entered into a licensing agreement with Rex for exclusive worldwide rights to market and distribute the Option inferior vena cava (IVC) filter, made by Rex Medical (Conshohocken, Pennsylvania), a device implanted into the body’s inferior vena cava to prevent pulmonary embolism (PE). Financial terms of the agreement were not disclosed.
The Option IVC filter 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. The company said the IVC can be successfully removed for a much longer time than anything else on the market (Medical Device Daily, Jan. 22, 2007).
“We believe that the Option 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 William Hunter, president/CEO of Angiotech.
“Data from our international clinical study has shown that the Option IVC filter can be successfully retrieved in patients for longer than one year,” said James McGuckin, co-founder of Rex.
Rex said it expects to complete enrollment in its U.S. clinical study for the Option IVC filter in the treatment of PE by the end of the second quarter of this year and anticipates that filing for FDA 510(k) clearance in the “near term”.
Rex filed for the CE Mark for the Option IVC filter and is awaiting response from the European regulatory bodies.
Pending approval, Rex said it expects the filter to be available for sale through Angiotech’s interventional sales force in the U.S. and in the EU by the end of 2008.
The U.S. market for IVC filters in 2007 was estimated at $200 million, with retrievable filters accounting for about two-thirds of this market.