Boston Scientific eyes FDA approval for MRI-safe pacer

Boston Scientific is seeking FDA approval for MRI-safe models of its Ingenio pacemaker and Ingevity leads.--Courtesy of Boston Scientific

Boston Scientific ($BSX) is racing to become just the second company with an MRI-safe pacemaker on the U.S. market, kicking off a global study of its ImageReady pacing system designed to win FDA approval.

The company has implanted the system, comprised of the Ingenio pacer and Ingevity leads, in its first U.S. patient, part of a study on up to 363 people at 45 sites in 7 countries. The trial, dubbed SAMURAI, will test how well the pacer-lead combo holds up in an MRI environment, amassing enough data to support FDA approval for the system, the company said.

"Physicians are very limited in device options and therapies labeled for use in the MRI setting," Johns Hopkins investigator Ronald Berger said in a statement. "The availability of a pacing system specifically designed to allow patients with pacemakers to undergo a broad set of MRI scanning conditions will advance the quality of patient care."

Boston Scientific picked up a CE mark for the system in July, but it lags behind Medtronic ($MDT), which won FDA approval for the MRI-friendly Revo in 2011 and the next-gen Advisa in February. Meanwhile, a cadre of cardiac devicemakers is queuing up to follow suit, with Biotronik in January winning the FDA's blessing to study its imaging-safe device in the U.S. and St. Jude Medical ($STJ) in the midst of an approval-minded trial for a similar technology.

But Boston Scientific says its system is more than just an MRI-OK version of old technology. The new leads beat out competitors in handling and fixation, the company said, and Ingenio ships with Boston Scientific's Latitude NXT remote monitoring system, allowing physicians and patients to keep tabs on heart function through a smartphone.

The cardiac rhythm management business has been less than kind to Boston Scientific over the past few years, but, as CEO Mike Mahoney has said, "these are challenging markets, but they are the markets we have to compete in."

Part of Mahoney's plan for getting his struggling company back to revenue growth is rolling out new devices to treat unmet needs, and with just one competitor in the stateside MRI-safe pacer market, FDA approval for the ImageReady system could go a long way toward mending CRM sales.

- read Boston Scientific's announcement