Boston Scientific (NYSE:BSX) said it won CE Mark approval in the European Union for its Ingevity pacemaker leads, designed to be safe during MRI scans.
The Natick, Mass.-based medical device company said it’s already launched the Ingevity leads in countries that recognize the CE Mark.
The leads are part of Boston Scientific’s ImageReady MR-conditional pacemaker family, which includes the Vitalio MRI, Formio MRI, Advantio MRI and Ingenio MRI pulse generators, according to a press release.
Back in December 2012, BSX launched a clinical trial of the Ingevity leads to back its approval bids in the U.S. and Europe. More than 1,600 patients have been implanted with the leads, which are classed as investigational devices in the U.S., according to the release.
"The Ingevity MRI pacing leads platform represents a significant milestone in our bradycardia technology and CRM lead portfolio," Michael Onuscheck, president of Boston Scientific Europe, said in prepared remarks. "We are proud to offer multiple, new and innovative CRM leads engineered for superior long-term clinical performance, including Ingevity MRI pacing leads, Reliance 4-Front defibrillation leads, and the Acuity X4 CRT family of leads."
