Boston Sci gets EU approval for MRI-safe pacemaker

Boston Scientific got European approval for MRI-safe models of the pacemakers Advantio and Ingenio (pictured)--courtesy of Boston Scientific

Boston Scientific ($BSX) has snagged a CE mark for MRI-friendly versions of the pacemakers Ingenio and Advantio, giving the company new marketable products in its flagging cardiac rhythm management unit.

The pacemakers, approved by the FDA in May, were re-outfitted with Boston Sci's Image Ready technology, allowing them to withstand the magnetism in MRI scans without overheating, the company said. The company's Fineline II leads, implanted in more than 1 million patients, are already compatible with MRI procedures.

Many patients with pacemakers suffer from other ailments that require frequent scans, Boston Sci says, and getting MRI-safe models of Ingenio and Advantio represents a significant advance in the company's pacemaker unit.

And Boston Sci could use just that. The company reported a $3.4 billion loss in the second quarter, driven mostly by a goodwill impairment charge but exacerbated by an 8% decline in sales for the cardiac rhythm management unit, which includes pacemakers. However, interim CEO Hank Kucheman told FierceMedicalDevices that Boston Sci is following through on its 2010 restructuring plan and sees a way forward.

"We all know our two biggest businesses are the ones we are facing headwinds, with CRM and [interventional cardiology], but the investment community has not given us a lot of [credit] for being able to grow over time," Kucheman said. "We believe we can get back to flat, to a maybe slightly positive outlook in 2013."

- read Boston Sci's release