Boston Scientific receives regulatory approval to market RELIANCE 4-FRONT in Europe and Asia

Boston Scientific Corporation (NYSE: BSX) has received regulatory approval to market the RELIANCE® 4-FRONT™ lead, its next generation implantable defibrillation lead now available in Europe and Asia.  Defibrillation leads are insulated wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator to the heart for treatment of heart failure and sudden cardiac arrest.

The RELIANCE 4-FRONT lead is built upon the demonstrated performance and reliability of the RELIANCE lead platform with design enhancements intended to simplify the implant procedure.  With more than 350,000 implants worldwide, RELIANCE leads have demonstrated a 98.9 percent survival probability at 8 years¹.

"Leveraging the RELIANCE platform, we made a series of targeted design enhancements with RELIANCE 4-FRONT to improve and simplify implantation," said Kenneth Stein, M.D., chief medical officer of Boston Scientific's Cardiac Rhythm Management Group.  "RELIANCE 4-FRONT represents our continued dedication to product innovation to meet the needs of patients and physicians."

Features of the new RELIANCE 4-FRONT lead include a modest size reduction in the lead body to improve handling and maneuverability while maintaining insulation thickness and reliability.  IROX, a fractal coating, has been added to enhance electrical properties and lower pacing thresholds.  The RELIANCE 4-FRONT lead also features a secured GORE™ coating, designed to prevent tissue ingrowth into the defibrillation coils.   Adhering the GORE coating to the new lead simplifies implantation by eliminating steps in the current procedure.

RELIANCE 4-FRONT is not available for sale in the United States.

RELIANCE 4-FRONT in AsiaIn Asia, one of the world's fastest-growing ICD markets, the first two implants of the RELIANCE 4-FRONT lead were performed by Razali Bin Omar, M.D. and Azlan Hussin, M.D. at the Institute Jantung Negara Hospital in Kuala Lumpu, Malaysia.

"As a long time user of the RELIANCE family of leads, I am pleased to see that the new lead builds upon the dependability I've come to appreciate with this platform," said Dr. Razali, Director of Clinical Electrophysiology and Pacemaker Service Department of Cardiology at the National Heart Institute in Kuala Lumpur, Malaysia.  "The RELIANCE 4-FRONT lead handles and maneuvers well during implantation, resulting in a smooth and efficient procedure."

RELIANCE 4-FRONT in EuropeIn Europe, a market where lead reliability is increasingly becoming a topic of focus, Boston Scientific is proud to be providing one of the most reliable leads on the market today, while continuing to strive for improvement through new technology.  Maurizio Gasparini, M.D., Director of Electrophysiology and Pacing Department at Humanitas hospital in Rozzano, Italy is one of the first implanters in Europe and one of the most experienced physicians with this technology.

"Boston Scientific has established itself as a leader in lead reliability through the RELIANCE family of leads," said Dr. Gasparini.  "RELIANCE 4-FRONT, the latest addition to this family, provides consistent outcomes and handles very well during the implantation procedure."