Heart Arrhythmia specialist, J&J company, Biosense Webster, Inc. has enrolled the first patient in a study to evaluate the safety and effectiveness of a pioneering Left Atrial Appendage (LAA) closure treatment.
The Biosense Webster, Inc. WaveCrest® Left Atrial Appendage Occlusion (LAAO) System is designed used for closure of the LAA. Ostensibly a safety and effectiveness study, WaveCrest will also evaluate reduction of embolic stroke in atrial fibrillation (AFib) patients who cannot tolerate chronic Oral Anticoagulation Therapy (OAC).
The study is a prospective, multicenter, randomized, active controlled clinical trial of the WaveCrest® Left Atrial Appendage Occlusion System compared to an existing FDA-approved LAA Closure Device for the reduction in risk of embolic stroke in subjects with non-valvular atrial fibrillation.
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 City. The trial will enroll 1,250 patients at approximately 90 hospitals, and follow them for five years.
“The WaveCrest® System is designed to enable physicians to close the heart’s LAA, where most stroke-causing blood clots occur,” said Dr. Chinitz. “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.”
“Preventing and reducing the risk of stroke in AFib patients is a significant unmet need,” said Shlomi Nachman, Company Group Chairman of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. “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.”
Source: Biosense Webster