SALT LAKE CITY--(BUSINESS WIRE)--Coherex Medical, Inc. announced it has received CE Mark approval for its Coherex WaveCrest™ LAA Occlusion System.
“We are extremely proud of the clinical results to date and anticipate quick adoption of the device in the commercial setting.”
Atrial fibrillation (AF) is the most common cardiac arrhythmia in today’s aging population, affecting nearly 6 million individuals in the US alone. AF causes the upper chambers of the heart to beat irregularly, slowing the flow of blood through these chambers and increasing the risk for stroke as this slower blood flow can cause clots to form.
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 (blood thinners) 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 altogether 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 worldwide clinical trial to study the safety and efficacy of the WaveCrest LAA Occlusion System. Added Mr. Martin, “We are extremely proud of the clinical results to date and anticipate quick adoption of the device in the commercial setting.”
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 US, 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.
“I am pleased to report that Coherex has accomplished three major objectives,” said Mr. Martin. “First, we have completed our WAVECREST I clinical trial. Second, we have successfully attained CE Mark clearance for the WaveCrest LAA Occlusion System. And third, we are partnering with Biosense Webster in a distribution agreement to market and sell our WaveCrest implant in many countries throughout the world. Biosense Webster is a market leader in atrial fibrillation with significant global reach and expertise. I am very excited that Coherex is entering into this distribution agreement with Biosense Webster.”
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.
About Coherex Medical
Formed in 2003, Coherex Medical addresses structural heart disease and conditions through the development of innovative medical devices. Please visit www.coherex.com or call 801-433-9900.