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 that focuses treatment where it belongs: In the PFO tunnel. Released in late 2009 in conjunction with our distribution partner, Abbott Vascular, the 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 completed preclinical testing to support first in man clinical study outside the United States during the latter half of 2010.
Coherex Medical - Dedicated to evolving clinical therapies addressing structural heart disease. Dedicated to finding Structural Heart Solutions.
* Data on file at Coherex Medical
Thank you for visiting the Coherex OUS (Outside United States) website. This website is intended for people residing outside of the United States of America.
This OUS site may contain information on products or uses of those products not approved in certain countries or regions.
If you are a resident of the USA, please return to www.coherex.com and choose the Coherex USA website.
PHYSICIAN TRAINING
Coherex is scheduling training sessions for OUS physicians interested in learning the in-tunnel method. To learn how to use The Coherex FlatStent™ EF PFO Closure System, please contact us at (801) 433-9900 or (800) 390-9107 or email: info@coherex.com
Notice: The Coherex FlatStent EF PFO Closure System has been CE Marked and is currently distributed outside the U.S.A. and Japan by Abbott Vascular. It is not available for investigational use or for commercial distribution at this time in the U.S.A.
