St. Jude Medical (NYSE:STJ) today touted the 1st U.S. implant of its Nanostim pacemaker, a leadless device implanted directly into the heart to help regulate abnormal heart rhythms.
The Nanostim pacemaker, which is implanted via the femoral vein with a transcatheter, is close to 10% the size of a normal pacemaker. Unlike standard pacemakers, the Nanostim does not use wire leads to connect its electrical generator with the heart.
The 1st implantation, performed by Dr. Vivek Reddy at the Mount Sinai Hospital in New York, is part of the Leadless II clinical trial, according to a press release.
“I believe this pioneering, compact device, which is placed directly inside the heart, may be a true game-changing technology in cardiovascular medicine that may help revolutionize care for patients with arrhythmias,” said Dr. Reddy, the study’s co-investigator, in a prepared statement. “I look forward to the results of the Leadless II clinical trial. Previous initial research testing of the device already showed overall its performance is comparable to traditional pacemakers.”
Two weeks ago, St. Jude heralded the 1st Nanostim implantation in a U.K. patient. St. Jude bought out Sunnyvale, Calif.-based Nanostim in October 2013 in a deal worth about $189 million, paying $123.5 million up front and putting another $65 million in revenue-based milestones on the table.
“Since the introduction of the first implantable pacemaker in 1958, pacemaker technology has continued to evolve into smaller, more efficient devices,” chief medical officer Dr. Mark Carlson said in prepared remarks. “Despite this evolution, pacing technology has, until now, required surgery in addition to leads that connect the pacemaker to the heart. The Nanostim leadless pacemaker is the first miniaturized device that removes the need for leads, thus offering less invasive and less complicated procedures for physicians and patients around the world. We believe the innovative nature of this technology will change the future landscape of cardiac rhythm management devices by revolutionizing the delivery methods and design of these life-saving technologies.”