Boston Scientific Launches New Implantable Defibrillation Lead In Europe, Asia
October 29, 2012 — Boston Scientific Corporation 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 eight years.
"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 Asia
In 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 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 Europe
In Europe, a market where lead reliability is increasingly becoming a topic of focus, Maurizio Gasparini, M.D., director of electrophysiology and pacing department at Humanitas Hospital in Rozzano, Italy is one of the first implanters and one of the most experienced physicians with this technology.
"Reliance 4-Front, the latest addition to this family, provides consistent outcomes and handles very well during the implantation procedure," said Gasparini.