On 3 September, Coherex Medical announced it has received the CE mark approval for its Coherex WaveCrest LAA Occlusion System. The WaveCrest is an implantable device that seals off the left atrial appendage (LAA) opening so clots cannot escape into the blood stream and cause a stroke.
“The Coherex WaveCrest LAA Occluder provides substantial benefits for patients with atrial fibrillation 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,” said Alex Martin, president and CEO of Coherex.
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. “We are extremely proud of the clinical results to date and anticipate quick adoption of the device in the commercial setting,” said Martin.
The company also announced that it has entered into an exclusive distribution agreement with Biosense Webster for the Coherex WaveCrest LAA Occlusion System.
Under terms of the agreement, Coherex will provide exclusive worldwide distribution rights, excluding the USA, 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.
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.