Boston Scientific Inc. has said that European Union regulators have approved a new system of wires used in implanted heart devices.
The company said its Endotak Reliance 4-site system has received marketing approval.
Defibrillation leads are insulated wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy defibrillator (CRT-D) to the heart and, when needed, deliver life-saving therapy. The Endotak Reliance 4-site lead system is designed to simplify the implant procedure by combining three terminals into one integrated connector, reducing the required implant area within the body.
This technology allows the world’s smallest, thinnest high-energy ICDs and CRT-Ds to become even smaller. The connector reduces the volume of Teligen and Cognis to 32 cc and 30 cc respectively, while maintaining a thickness of less than 10 mm.
Boston Scientific said its new device is smaller, combining three wire terminals into one connector. It added that the Endotak Reliance 4-site lead system complies with an upcoming international connector standard. Three physicians from Germany and one from the Netherlands performed the human implant of the lead system.
The company is working with physicians to launch the system in several phases with a focus on monitoring clinical performance through robust post-market analysis enhanced by the Latitude Patient Management system. The Latitude Patient Management system is not yet approved in Europe.
