Initial Investment Date: 05/2011
Coherex Medical was founded with the initial goal of developing a PFO closure device that would be a technological advance over historical PFO devices, and be easy for interventional cardiologists to use. The result of that effort is the Coherex FlatStent EF PFO Closure System, the first PFO device approved for sale in Europe that focuses treatment where it belongs: In the PFO tunnel.
Released in late 2009 in conjunction with our distribution partner, Abbott Vascular, the Coherex FlatStent EF provides three distinct closure mechanisms: lateral force exerted by the deployed FlatStent to close the tunnel from within, a foreign body response to the implant to stimulate endothelialization, and a polymer substrate to promote cellular integration within the tunnel. In conjunction with these advances in PFO treatment, complications commonly associated with historical devices were noted to be less frequent with the FlatStent EF in the European trial performed to achieve the CE mark.* The Company is designing a randomized trial to be executed in the USA with the goal of demonstrating safety and efficacy in selected patients with Migraine.
As the PFO program progressed from product development to commercialization, the Company, in response to feedback received from the structural heart community of physicians, initiated its next product development program: Percutaneous Occlusion of the Left Atrial Appendage. This program has completed preclinical testing to support first in man clinical study of the Coherex WaveCrest LAA Occlusion System outside the United States during 2010 and 2011.