Californian device company Nanostim, Inc., has announced the first successful implants of a leadless pacemaker in a series of 11 patients at Homolka Hospital in Prague, Czech Republic. What’s interesting is the fact that Nanostim has thus far operated so far below the radar that it doesn’t even have an active website at this time, so it’s a clear sign of positive developments that it has decided to break cover with this news.
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 utilises 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 a lead.
Nanostim says it’s 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.
The new pacemakers were implanted by Dr. Petr Neuzil, Head of Cardiology at Homolka Hospital, Prague, and Dr. 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, multicentre study that will be conducted in up to eight centers in Europe to gather data in support of CE Mark approval.
St. Jude Medical has an exclusive option to purchase Nanostim upon the completion of certain development milestones as reported last May, here.
Implanting physician Dr. Vivek Reddy said, “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 miniaturisation 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.”
Dr. Neuzil added, “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.”
“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.”
Source: Nanostim, Inc., Business Wire