SUNNYVALE, Calif.–(BUSINESS WIRE)–May 10, 2013–Nanostim, Inc., a privately-owned developer of miniaturized, leadless cardiac pacemakers (LCP), today announced preliminary results from its LEADLESS study during the late breaking clinical trial presentations at Heart Rhythm 2013, the Heart Rhythm Society’s 34 th Annual Scientific Sessions in Denver. Early findings from the study of the world’s first self-contained, leadless cardiac pacemaker demonstrated overall device performance comparable to conventional pacemakers.
The LEADLESS study is a prospective, single-arm, multicenter study evaluating more than 30 patients. Initial findings from the study, which follow device performance and assess patient outcomes through 90 days of follow-up, demonstrate pacing thresholds (0.51 volts) and sensing thresholds (10.6 mV), which measure the minimum level that must be reached for an effect to be produced, are equivalent to those found in conventional pacemakers. Total procedural times averaged 28 minutes.
“These initial findings give us significant insight into the feasibility of this pioneering technology,” said Dr. Vivek Reddy, director of electrophysiology at Mount Sinai Hospital, N.Y. “The device’s ease of delivery, coupled with its ability to be acutely repositioned and later retrieved if necessary, gives physicians a less-invasive option that may ultimately revolutionize the delivery of pacemaker therapy.” There were no significant device-related adverse events and one significant procedure-related adverse event (perforation). This event rate is comparable with adverse event rates associated with conventional pacemakers. Because this minimally-invasive approach eliminates the surgical pocket and lead, the device has the potential to reduce overall complications, specifically infection and lead failure. There was no failure to sense, pace or communicate with the pacemaker and no infections in these early data.
The small size of the device, less than 10 percent the size of a conventional pacemaker, allows for percutaneous placement through the femoral vein with a steerable catheter. Even with miniaturization, initial results indicate battery longevity is comparable to conventional pacemakers, with an average lifespan of 8.5 years at 100 percent pacing.
The study is being conducted in Europe to gather data in support of CE Mark approval. Devices were implanted at Homolka Hospital, Prague, Czech Republic; Academic Medical Center (AMC) Hospital in Amsterdam, the Netherlands; and Institute for Clinical and Experimental Medicine (IKEM) Hospital in Prague, Czech Republic. The study’s principal investigator is Dr. Johannes Sperzel, at the Kerckhoff Klinic in Bad Nauheim, Germany.
“We are looking forward to the potential benefits this technology will be able to offer our patients,” said Dr. Petr Neuzil, head of cardiology at Homolka Hospital in Prague, Czech Republic. “The elimination of the surgical pocket and lead has the potential to reduce long-term patient complications.” In a conventional pacemaker procedure, an incision is made in the upper chest and one or more leads are guided through a vein into the heart. The pacemaker is then connected to the lead(s) and inserted beneath the skin and the incision closed. Nanostim’s leadless pacemakers are implanted via a percutaneous, catheter-based procedure. The devices are placed directly into the heart and are designed without the requirement for a lead or surgical pocket.
The Nanostim approach is designed to improve patient comfort by giving the physician a less-invasive option, permitting implantation as an outpatient and eliminating the visible lump and scar at a conventional pacemaker’s pectoral implant site. Because of the elimination of the lead, the device is inherently MRI compatible and also removes the need for activity restrictions to prevent dislodgement after implantation of a conventional lead.
“We’re excited with these outstanding preliminary results,” said Drew Hoffmann, chief executive officer of Nanostim, Inc. “We remain confident that the LEADLESS study will further our understanding of the benefits of this innovative, minimally-invasive technology and look forward to making this important technology available to patients and physicians worldwide.” Nanostim is an emerging medical device manufacturer that is developing a self-contained leadless cardiac pacemaker system. The company is backed by InterWest Partners, US Venture Partners, Emergent Medical Partners, Life Science Angels and St. Jude Medical, which has an exclusive option to purchase Nanostim upon the completion of certain development milestones.
