Boston Scientific Launches DIRECTSENSE™ Technology for Enhanced RF Ablation Monitoring

MARLBOROUGH, Mass., June 4, 2020 /PRNewswire/ -- Boston Scientific (NYSE: BSX) announced the U.S. launch of DIRECTSENSE™ Technology, a tool that monitors the efficacy of radiofrequency energy delivery during cardiac ablation procedures. Carried on the RHYTHMIA HDx™ Cardiac Mapping System, DIRECTSENSE Technology received approval from the U.S. Food and Drug Administration in April. It is the only technology capable of monitoring changes in local impedance (resistance) near the tip of the INTELLANAV™ Magnetic Location Microelectrode Irrigated Ablation Catheter, providing physicians with an additional measure of therapeutic effect during ablation.

Ablation is a treatment for patients with arrhythmia, in which physicians use catheters to create lesions and destroy the cardiac tissue responsible for the arrhythmia. Prior to initiating therapy, DIRECTSENSE technology provides data on impedance around the catheter tip to measure the patient’s tissue responsiveness to radiofrequency energy. During ablation, this tool tracks changes in local impedance and integrates them with other measurements, enabling physicians to clearly assess tissue characteristics and the impact of procedural maneuvers on the tissue. These data reflect changes in tissue temperature, thereby helping to reduce the risk of excessive ablation and avoid complications.

“Changes in catheter tip impedance provide us with unique information about local tissue characteristics and the progression of lesion formation,” revealed Dr. David J. Callans, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine (the first medical center in the United States to utilize this new technology). “Unlike existing products on the market, DIRECTSENSE technology helps physicians assess tissue health prior to ablation and provides clearer insight into how procedural maneuvers affect the tissue during the procedure, thereby enabling minimally invasive and predictable ablation.”

A retrospective analysis of the DIRECTSENSE technology presented by Dr. Ignacio Garcia Bolao, Director of Cardiology and Cardiovascular Surgery at the University of Navarra in Pamplona, Spain, at the 2020 Heart Rhythm Society Annual Scientific Sessions, demonstrated that based on long-term data from the LOCALIZE clinical trial, a local impedance drop of ≥16.6 ohms and an inter-lesion distance of ≤6 mm in patients with paroxysmal atrial fibrillation (AF) yielded a positive predictive value of ≥98% for durable pulmonary vein isolation at 3 months.

“Building on the success of DIRECTSENSE technology in Europe, we are honored to introduce this tool to physicians and patients in the United States,” said Dr. Kenneth Stein, Senior Vice President of Rhythm Management and Global Health Policy and Chief Medical Officer at Boston Scientific. “The FDA approval marks an exciting milestone for our expanding electrophysiology portfolio, which enables physicians to gain more intuitive insights into lesion formation and procedural efficiency, thereby ensuring optimal therapeutic outcomes for patients.”

Boston Scientific has been continuously expanding its electrophysiology product portfolio. Recently, the Boston Scientific POLARx™ Cryoablation System received CE marking, prompting the company to plan for its launch and to begin enrolling European patients in a post-market registry study within the coming months. The introduction of this novel single-ablation therapy, complementing its existing products and services, underscores Boston Scientific’s ongoing commitment to delivering meaningful technological innovations for the treatment of atrial fibrillation patients.

Note: This product is not yet available in mainland China.

For more information about the Boston Scientific electrophysiology portfolio, please visit:www.bostonscientific.com/rhythmia

About Boston Scientific

Boston Scientific Corporation is committed to innovating for life. We are dedicated to developing innovative medical solutions that improve the lives of patients worldwide. For more than 40 years, Boston Scientific has been a leader in the global medical technology industry, providing a broad portfolio of high-performance medical solutions to address the urgent therapeutic needs of patients and reduce healthcare costs. For more information, please visit our corporate website:www.bostonscientific.cn

About Boston Scientific in Greater China

Boston Scientific established its China headquarters in Shanghai in 1997 and currently maintains branch offices in Beijing, Shanghai, Guangzhou, Chengdu, Hong Kong, and Taiwan. The company’s core business areas include interventional cardiology, structural heart disease, cardiac rhythm management and electrophysiology, endoscopic interventions, peripheral and oncology interventions, urology and pelvic health, and respiratory products. Upholding its tradition as an innovation leader, Boston Scientific is committed to becoming the most innovative international medical technology company that best meets the needs of Chinese patients and healthcare providers by delivering high-quality medical products and services for prevention, diagnosis, and treatment. For more information, please visit the company’s website:www.bostonscientific.cn

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