Crux Biomedical’s product includes the Crux VCF system, an inferior vena cava (IVC) filter, which is designed for treating patients with pulmonary embolisms (PEs) in whom anticoagulation is contraindicated or ineffective.
The FDA-approved and CE-marked system also features a helical design that self-centers and 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 IVC filter’s retrieval success of 98% with no embolization, migration and fracture.
Under the terms of the agreement, Volcano will pay up to approximately $3.1m in Crux transaction expenses.
Volcano will also pay post-closing cash milestone payment of $3m, upon the US FDA clearance of a 510(k) application submitted by the company on or before 30 June 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.
Volcano said once full-scale manufacturing is implemented at its Rancho Cordova facility in California, US, it will begin commercial sales of Crux products at the end of 2013.
In addition, Volcano is planning to seek regulatory approval to market the Crux VCF system in combination with its intravascular imaging technology.