St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first enrollments in the company’s LEADLESS Pacemaker Observational Study evaluating the Nanostim™ leadless pacing technology. The Nanostim pacemaker received CE Mark in 2013, and post-approval implants have occurred in the UK, Germany, Italy, Czech Republic, France, Spain, and the Netherlands.
The Nanostim leadless pacemaker from St. Jude Medical is less than 10 percent the size of a conventional pacemaker. (Photo: Business Wire)
The LEADLESS Pacemaker Observational Study is a prospective, multi-center, post-market clinical study designed to build additional evidence to support the safety profile of the Nanostim leadless pacemaker in patients indicated for ventricular single chamber pacing. It will provide long-term data about the Nanostim leadless pacemaker and will seek to demonstrate additional information about the long-term performance of the device. The trial is the largest to study leadless pacemakers, and will enroll approximately 1,000 patients in approximately 100 centers in Europe. “This large, European study was uniquely designed to help assess the health benefits associated with the Nanostim leadless pacemaker,” said Dr. Johannes Sperzel, principal investigator (PI) in the study and head of the electrophysiology department at the Kerckhoff Klinik in Bad Nauheim, Germany. “We look forward to adding to the already strong clinical evidence supporting the benefits to patients receiving this revolutionary technology.” About the Nanostim Leadless Pacemaker Unlike conventional pacemakers that require a more invasive surgery, Nanostim is designed to be implanted directly into the heart via a non-surgical procedure. The device is designed to be placed without the visible surgical pocket, scar and insulated wires (called leads) required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device is designed to be fully retrievable so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.