Boston Scientific Earns FDA Approval for MR-Conditional Pacing System

FDA approved Boston Scientific's MR-conditional pacing system on Monday, a move that also gives the company the first passive fixation pacing lead for MR scans in the United States.

The approval of the ImageReady MR-Conditional Pacing System covers Boston Scientific's Accolade MRI and Essentio MRI pacemakers and the Ingevity MRI pacing leads in both active and passive fixation offerings, according to a company release. This technology allows pacemaker patients to undergo 1.5 T full-body MR scans. The system can also be used with the company's Latitude NXT Patient Management System, which allows remote daily patient monitoring. 

"With a pacing system specifically designed with automatic remote monitoring that also allows patients to undergo MR scans, we are further advancing the quality of patient care," Kenneth Stein, MD, chief medical officer of Boston Scientific's Rhythm Management business, said in the company release.

In an email, Stein elaborated on the importance of the passive fixation lead approval. "Passive fixation leads are often used in patients with thinner cardiac walls to minimize risk of perforation or other implant complications," he wrote. "This approval gives physicians the option to use an active or passive fixation lead that is also deemed safe for use in an MRI environment based on the patient's individual needs. Historically, passive fixation leads have made up 10-15% of bradycardia lead implants."

The company studied the safety and effectiveness of the Ingevity leads with its 1036-patient, prospective, non-randomized INGEVITY trial. The prospective, randomized SAMURAI trial studied the safety and effectiveness of the ImageReady System for pacemaker patients undergoing an MR scan.

The announcement comes just days after rival St. Jude Medical said its MR-conditional Assurity pacemaker is delayed at FDA as both CDRH and CDER are reviewing the company's PMA submission.

Boston Scientific joins Medtronic in offering an MR-conditional pacemaker. In addition, Boston Scientific plans to gain FDA approval of an MR-conditional Emblem S-ICD in the third quarter of 2016 and a U.S. approval of an MR-conditional ICD in the second or third quarter of 2017, according to management commentary on the company's February earnings call.

Stein noted that the ImageReady System was launched upon approval and implants are expected later this week.

[Image courtesy of BOSTON SCIENTIFIC]