CE Mark Approved for Coherex's WaveCrest LAA Occlusion System

September 3, 2013—Coherex Medical, Inc. (Salt Lake City, UT) announced it has received CE Mark approval for its Coherex WaveCrest left atrial appendage (LAA) occlusion system. The WaveCrest LAA occluder is an implantable device that seals off the LAA opening so clots cannot escape into the bloodstream and cause a stroke. The LAA is recognized as the source of blood clots in approximately 90% of patients who have atrial fibrillation, noted the company.

According to the company, the WaveCrest offers a one-time treatment option for patients who would otherwise be on a lifetime regimen of anticoagulation therapy or who are contraindicated to anticoagulants altogether and would, therefore, be unprotected from the risk of cardio embolism.

Coherex presented results from the WAVECREST I clinical trial in May at EuroPCR 2013, the Paris Course on Revascularization. The company has been conducting a worldwide clinical trial to study the safety and efficacy of the WaveCrest LAA occlusion system.

In related news, Coherex announced that it has entered into an exclusive distribution agreement with Biosense Webster Inc. (Diamond Bar, CA) for the Coherex WaveCrest LAA occlusion system. Coherex will provide exclusive worldwide distribution rights, excluding the United States, to Biosense Webster for the Coherex WaveCrest device. Biosense Webster, along with its affiliated company, Cordis Corporation (Bridgewater, NJ), will promote, train, sell, and support the WaveCrest device. Coherex Medical will manufacture the Coherex WaveCrest LAA Occlusion System at its facility in Salt Lake City. Coherex expects to have a controlled product launch in Europe and plans to conduct additional clinical trials designed to lead to final approval in the United States and Japan.