FDA Panel Advises on Leadless Pacing Technology in U.S.

The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has provided feedback to support the adoption of leadless pacing technology in the United States. The feedback follows a panel discussion today on leadless pacing technology that included a broad overview of the clinical experience with St. Paul, Minn.-based St. Jude Medical Inc.’s Nanostim leadless pacemaker.

“As the world’s first commercially-available leadless pacemaker with the industry’s least invasive and smallest delivery system, the Nanostim leadless pacemaker was designed to address a number of issues associated with conventional pacemakers and traditional pacemaker leads,” said Mark Carlson, M.D., vice president of global clinical affairs and chief medical officer at St. Jude Medical, who presented to the FDA panel on behalf of the company. “Leadless pacing technology is a critical advancement for patients in need of a single-chamber ventricular pacemaker, and we are optimistic that today’s discussion is an important step toward offering patients leadless pacing technology in the United States.”

After a presentation on the clinical experience with the Nanostim leadless pacemaker, the FDA’s Circulatory System Devices Panel provided recommendations that were consistent with many of St. Jude Medical’s proposed recommendations related to post approval study design and training for physicians who seek to offer the Nanostim leadless pacemaker to their patients. The panel also provided valuable insight around patient selection and post approval study methodology.

The Nanostim leadless pacemaker operates like a traditional pacemaker, but is 10 percent the size of a conventional pacemaker and is designed to reduce or eliminate complications associated with leads, chest incisions and surgical pockets. The Nanostim leadless pacemaker received CE Mark approval in October 2013. To date, more than 1,000 Nanostim leadless pacemakers have been implanted worldwide.

Recent data from the Leadless II IDE (investigational device exemption) study published in The New England Journal of Medicine confirmed the benefits of the Nanostim leadless pacemaker. The LEADLESS II study also highlighted the retrievability of the Nanostim leadless pacemaker, which allows the Nanostim leadless pacemaker to be repositioned throughout the implant procedure and retrieved even after more than a year implanted in patients when necessary.

“We’re highly appreciative of the FDA’s proactive effort to gain more insight and understanding around leadless pacing technology, and for the opportunity to participate in the dialogue that will help ensure that leadless technology is adopted with patient safety in mind and with successful clinical outcomes as a top priority,” Carlson said.

The Nanostim leadless pacemaker is not approved in the United States and is limited by federal law to investigational use.