December 21, 2012 — Nanostim Inc. announced the first successful implants of a leadless pacemaker in a series of 11 patients at Homolka Hospital in Prague, Czech Republic. The leadless pacemakers were implanted by Drs. Petr Neuzil, head of cardiology at Homolka Hospital, and Vivek Reddy, director of electrophysiology at Mount Sinai Hospital in New York. The patients were enrolled in the company’s LEADLESS study, which is designed to examine the safety and effectiveness of the first totally self-contained, leadless pacemaker. The study is a prospective, single-arm, multicenter study that will be conducted in up to eight centers in Europe to gather data in support of CE mark approval.
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 is closed. Nanostim utilizes a catheter-based approach through the femoral vein delivering a self-contained leadless pacemaker directly into the heart without the need for a surgical pocket or lead.
“Nanostim’s leadless cardiac pacemaker represents a paradigm shift in the treatment of bradycardia patients and one of the most significant advances in pacemaker technology in decades. This novel miniaturization of the pacemaker changes the delivery of pacemaker therapy from a surgical procedure with a chest wall incision to a non-surgical percutaneous one. We look forward to offering this important technology to our patients,” said Reddy.
Added Neuzil, “I am impressed with the ease of implantation of the pacemaker and particularly with the intuitive controls on the delivery catheter. The procedural times were short, and the pacemaker performed just like a conventional pacemaker.”
The Nanostim approach is designed to improve patient comfort by giving the physician a simplified, less invasive option, permitting implantation as an outpatient, eliminating the visible lump and scar at a conventional pacemaker’s pectoral implant site, and removing the need for activity restrictions to prevent dislodgement after implantation of a conventional lead. Because this new approach eliminates the surgical pocket and lead, the device has the potential to reduce overall complications, specifically infection and lead failure.
“We’re excited to achieve this important milestone and move closer to offering this innovative technology to patients around the world,” said Drew Hoffmann, CEO of Nanostim Inc. “As we take another step towards commercialization, we continue to value the support of our investors, including St. Jude Medical, a proven global leader in the care of CRM patients.”
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.