The 1,250-patient study is designed to assess the safety and efficacy of the WaveCrest left atrial appendage occlusion system as a way to reduce the risk of embolic stroke in atrial fibrillation patients.
“The WaveCrest System is designed to enable physicians to close the heart’s LAA, where most stroke-causing blood clots occur,” Dr. Larry Chinitz, who treated the first patient in the trial at New York University Hospital, said in prepared remarks. “For patients with AFib seeking an alternative to anticoagulants or blood thinners, this may be an important procedural option that could reduce the risk of stroke and save lives.”
Irvine, Calif.-based Biosense Webster acquired the WaveCrest system when it bought Coherex Medical for an undisclosed amount in Nov. 2015.
“Preventing and reducing the risk of stroke in AFib patients is a significant unmet need,” Shlomi Nachman, chairman of Johnson & Johnson’s medical devices cardiovascular & specialty solutions business, added. “We are committed to investing in meaningful innovation and are excited by the prospect of bringing the WaveCrest System to the U.S. market so that more patients can benefit.”
The WaveCrest device won CE Mark clearance in the European Union in Sept. 2013, but is not yet approved for use in the U.S.