Medtronic (NYSE:MDT) said the 1st patient in a clinical trial of its its Micra pacemaker was implanted with the vitamin-sized device, which does not use wires threaded through blood vessels to regulate heart rhythm.
The 780-patient trial, a single-arm study, is expected to deliver 3-month data from the 1st 60 patients during the 2nd half of the year, according to a press release.
The Micra pacemaker is delivered via catheter to the heart, where it is attached to the heart wall with small tines. Pacing impulses are delivered from an electrode on the end of the device, rather than via leads threaded into the heart from a pulse generator inserted into a pocket in the chest wall.
Dr. Larry Chinitz of the NYU Langone Medical Center in New York performed the procedure, according to the release.
"With its small size and minimally invasive procedure, this technology represents the future of pacing," Chinitz said in prepared remarks. "Eliminating the need for a lead and pocket has the potential to reduce complications and recovery times compared to traditional pacemaker implants, which would be a major benefit to patients."
"Micra TPS is an example of the significant investment we have made in disruptive technology, specifically the miniaturization of implantable cardiac devices," added Medtronic cardiac rhythm disease management president Pat Mackin. "Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency. The FDA’s interactive review with CRDM was a key part of the IDE application approval process, and through our global Micra TPS clinical trial, we intend to generate robust evidence of these benefits to patients and clinicians throughout the world."
Fridley, Minn.-based Medtronic hopes that the Micra device will help it gain share in the cardiac rhythm management market.
"The key about that product is that its insertion mechanism is much easier and it’s much more targeted as a therapy. We think that, from an overall procedure basis, this will lead to greater efficiency in the system and probably expand access, because especially outside the U.S., where a greater number of physicians can probably do the procedure, where there’s an issue of the availability of such solutions. So we see that as a fairly fundamental change in the way pacing will be done in the future over the long term," chairman & CEO Omar Ishrak told analysts during a conference call earlier this week.
Medtronic is chasing cross-town rival St. Jude Medical (NYSE:STJ) and its Nanostim device in the race to get a leadless pacemaker on the market. St. Jude, which in October 2013 acquired Nanostim in a deal worth about $189 million, touted its own debut U.S. implantation earlier this month; Nanostim is already on the market in Europe under a CE Mark approval.
The 3rd member of the cardiac rhythm management triumvirate, Boston Scientific (NYSE:BSX), jump-started the minimally invasive CRM game with the 2012 acquisition of Cameron Health and its S-ICD defibrillator. The S-ICD device, although not a truly "leadless" pacemaker, uses wires tunneled under the chest muscles that deliver pacing impulses through the sternum.
