Boston Scientific Corporation reports that it has received approval to market the Reliance® 4-Front™ implantable defibrillation lead in Europe and has released the product here (and in parts of Asia).
The medical device industry is universally familiar with ICD leads, but in case you’re new to the subject, they are insulated wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy defibrillator to the heart for treatment of heart failure and sudden cardiac arrest.
Boston Scientific says its new 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.
The Reliance 4-Front lead features 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.
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 Lumpur, 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.”
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.”
“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.”
Reliance 4-Front is not available for sale in the United States.
1 Survival probability is comprised of all Reliance and Reliance G models combined as one population. Data source and data cut off is based on the BSC Q2 2012 Product Performance report. Data and calculations on file.
Source: Boston Scientific Corporation, PR Newswire