Coherex Medical Announces CE Mark for WaveCrest LAA Occlusion System
Exclusive Distribution Agreement with Biosense Webster
SALT LAKE CITY – September 3, 2013 - Coherex Medical, Inc. announced it has received CE Mark approval for its Coherex WaveCrest™ LAA Occlusion System.
The Left Atrial Appendage (LAA) is a pouch like cul-de-sac attached to the left atrium, which is recognized as the source of blood clots in approximately 90% of patients who have AF. Historically, patients who are at increased risk for stroke due to other medical conditions have had to take anticoagulants to help prevent these clots from forming. These anticoagulant medications have many side effects, and in many patients may not be tolerated over the long term. The WaveCrest LAA Occluder is an implantable device that seals off the LAA opening so clots cannot escape into the blood stream and cause a stroke.
According to Coherex President and CEO Alex Martin, “The Coherex WaveCrest LAA Occluder provides substantial benefits for patients with AF who are at high risk for stroke. The WaveCrest is a one-time treatment option for patients who would otherwise be on a lifetime regimen of anticoagulation therapy or who are contraindicated to anticoagulants all together and would therefore, be unprotected from the risk of cardio embolism.”
Coherex recently presented results from the WAVECREST I clinical trial at the Paris Course on Revascularization (PCR). The company has been conducting a world-wide clinical trial to study the safety and efficacy of the WaveCrest LAA Occlusion System.
The company also announced today that it has entered into an exclusive distribution agreement with Biosense Webster Inc. for the Coherex WaveCrest LAA Occlusion System.
Under terms of the agreement, Coherex will provide exclusive worldwide distribution rights, excluding the U.S., to Biosense Webster for the CE-marked Coherex WaveCrest Device. Biosense Webster, along with its affiliated company, Cordis Corporation, 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.
The company expects to have a controlled product launch in Europe. Coherex plans to conduct additional clinical trials designed to lead to final approval in the USA and Japan.
Please visit www.coherex.com or call 801-433-9900.