Crux Biomedical's commercial products include the FDA-approved and CE-marked inferior vena cava (IVC) filter, designed for treating patients with pulmonary embolisms (PEs) where anticoagulation is contraindicated or ineffective.
Featuring a helical design that self-centres, the Crux VCF system facilitates bi-directional retrieval through either the femoral or jugular veins.
Pivotal studies including RETRIEVE 2, 3 and 4, which enrolled 125 patients at high risk for PE, have demonstrated that the IVC filter has a retrieval success of 98% with no embolisation, migration and fracture.
Under the terms of the agreement, Volcano will pay up to approximately $3.1million in Crux transaction expenses.
Volcano will also pay a post-closing cash milestone payment of $3 million, upon the US FDA clearance of a 510(k) application submitted by the company on or before June 30, 2013, for a retrieval device being developed by Crux.
In addition, based on sales of Crux products following the commercial launch, Volcano is expected to make additional cash payments for up to four years.
Officials for Volcano say once full-scale manufacturing is implemented at its Rancho Cordova facility in California, it will begin commercial sales of Crux products at the end of 2013.
Crux Biomedical chairman Randy Lindholm says; "We believe Volcano is the perfect partner for us and is uniquely positioned to generate widespread adoption of the Crux VCF."
Volcano is also planning to seek regulatory approval to market the Crux VCF system in combination with its intravascular imaging technology.