Johnson & Johnson Targets $34 Billion U.S. Stroke Market with Investigational WaveCrest® Left Atrial Appendage Occlusion System for Atrial Fibrillation Patients

VCBeat (WeChat ID: vcbeat) recently learned that Biosense Webster, a subsidiary of Johnson & Johnson MedTech, is conducting clinical studies to evaluate the safety and efficacy of the WaveCrest® Left Atrial Appendage Occlusion System.This study aims to evaluate the system's efficacy in reducing the risk of stroke among patients with atrial fibrillation who are intolerant to long-term oral anticoagulant (OAC) therapy.。

The first patient has already received treatment from Dr. Larry Chinitz, an electrophysiologist at the NYU Langone Heart Rhythm Center at NYU Langone Health. The research team will subsequently enroll 1,250 patients across approximately 90 hospitals for a clinical trial and follow up with them for five years.

Dr. Chinitz stated, “Most blood clots that cause strokes occur in the left atrial appendage. The WaveCrest® Left Atrial Appendage Occlusion System is designed to enable physicians to close the left atrial appendage, thereby reducing the risk of stroke. For patients with atrial fibrillation seeking alternatives to anticoagulants or blood thinners, this may represent a highly promising option.”

According to the latest 2016 epidemiological report on stroke (stroke and apoplexy refer to the same disease, differing only in terminology), there are currently 70 million stroke patients in China, with 2 million new cases and 1.65 million deaths annually. Approximately three-quarters of survivors experience varying degrees of disability. As population aging intensifies, the number of individuals affected by this disease is expected to rise.

According to data from the American Stroke Association,The United States spends $34 billion annually on stroke-related care., patients with atrial fibrillation have a more than fivefold higher risk of stroke compared to the general population. The U.S. Centers for Disease Control and Prevention (CDC) estimates that 87% of strokes are ischemic, caused by blood clots blocking blood flow to the brain.

Shlomi Nachman, Group Chairman of Johnson & Johnson MedTech’s Cardiovascular and Specialty Solutions group, stated, “There is a significant societal need to prevent and reduce the risk of stroke in patients with atrial fibrillation. We are committed to investing in these meaningful innovations, and if the WaveCrest® Left Atrial Appendage Occlusion System is approved for marketing in the United States, it will benefit more patients.”

Although the system is still in the clinical trial phase in the United States, it has already received CE certification in Europe.

Biosense Webster, a subsidiary of Johnson & Johnson in the United States, is a specialized medical device company dedicated to the research and development of electrophysiology interventional diagnostic and therapeutic products, primarily providing comprehensive solutions for arrhythmia management. It is the inventor of the world’s first steerable catheter.

Guided by the needs of electrophysiology experts and patients, the company has continuously introduced innovative technologies and products for arrhythmia treatment, ranging from the first steerable electrophysiology catheter to the LASSO circular mapping catheter, and ultimately to today’s most advanced three-dimensional electroanatomic mapping system—Carto XP.

The name Biosense Webster has become synonymous with the design and manufacturing of electrophysiology catheters. In 1993, Biosense technology pushed cardiac imaging to new heights, and Biosense Webster is recognized as an industry leader in the field of arrhythmia treatment.

Over the decades of its development in China, Biosense Webster has maintained close collaborations with electrophysiologists and physicians, introduced cutting-edge technologies to the Chinese market, and trained a large cohort of early- and mid-career cardiovascular physicians.