IDE Clinical Trial Begins for BioSense Webster's WaveCrest LAAO Device
January 11, 2018—Johnson & Johnson Medical Devices Companies announced that the first patient was enrolled in the WaveCrest investigational device exemption trial of the WaveCrest device from Biosense Webster, Inc., a Johnson & Johnson company that focuses on the diagnosis and treatment of heart arrhythmias. The first patient was treated at New York University (NYU) Hospital by Larry Chinitz, MD, a Cardiac Electrophysiologist and Director of NYU Langone's Heart Rhythm Center in New York, New York.
According to the company, the trial will evaluate the safety and effectiveness of the WaveCrest left atrial appendage occlusion (LAAO) system in closure of the left atrial appendage (LAA) and evaluate the reduction of embolic stroke in atrial fibrillation patients who cannot tolerate chronic oral anticoagulation therapy. Investigators will enroll 1,250 patients at approximately 90 hospitals and follow them for 5 years.
In the company's announcement, Dr. Chinitz commented, "The WaveCrest system is designed to enable physicians to close the heart's LAA, where most stroke-causing blood clots occur. For patients with atrial fibrillation 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."
The study is a prospective, multicenter, randomized, active controlled clinical trial of the WaveCrest LAAO system compared to an existing US Food and Drug Administration-approved LAA closure device for the reduction in risk of embolic stroke in patients with nonvalvular atrial fibrillation.
The WaveCrest device has received CE Mark approval and is commercially available in Europe. In the United States, it is under clinical study and not approved for use.