Boston Scientific Corp. landed CE Mark approval from the European Union for its new Endotak Reliance 4-Site defibrillation lead system and announced the first human implants of the device in Europe.
The leads, which are insulated wires connecting an implantable defibrillator with the heart, are part of a suite of products the Natick devices giant acquired in its disastrous, $27 billion buyout of Guidant Corp.
The new lead system is designed to accomplish a few things, not least of which is erasing the bad taste lingering in investors’ mouths after the Guidant fiasco. It combines three terminals into a single, integrated connector, with an eye toward reducing the size of the implanted defibrillator.
Patients in Germany and the Netherlands were implanted with the new leads as part of BSC’s phased launch of the system, which will involve monitoring clinical performance.