St. Jude Medical Continues Leadless Pacemaker Push

St. Jude Medical Inc. has announced the first European enrollments in its Nanostim Leadless Pacemaker Observational Study as it moves forward with efforts to commercialize next-generation pacemaker technology.The Leadless Pacemaker Observational Study is a prospective, multicenter, postmarket clinical study, St. Jude Medical said Tuesday. This European clinical trial is intended to build evidence supporting the safety profile and performance of St. Jude Medical's Nanostim. It will enroll approximately 1000 patients in approximately 100 centers in Europe.

The trial will provide data about the long-term performance of the device. Johannes Sperzel, MD, principal investigator in the study and head of the electrophysiology department at the Kerckhoff Klinik (Bad Nauheim, Germany) said, "We look forward to adding to the already strong clinical evidence supporting the benefits to patients receiving this revolutionary technology."Meanwhile in the United States, the Leadless II pivotal trial is designed to evaluate the Nanostim leadless pacemaker for FDA approval. This study's first U.S. implant took place in February. This trial is being conducted under an Investigational Device Exemption (IDE) and will enroll approximately 670 patients at up to 60 centers worldwide, with up to 50 sites in the United States. St. Jude Medical, which first invested in Nanostim (Milpitas, CA) in 2011, bought the company last October for $123.5 million just after the company received the CE Mark for its device. As part of the deal, St. Jude Medical also agreed to pay an additional $65 million if regulatory and sales milestones were hit.Competitors include Medtronic, which is moving forward with studies on its own leadless pacemaker, the horse pill-sized Micra Transcatheter Pacing System that is only one-tenth the size of a standard pacemaker.

The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker. St. Jude Medical says it is the least invasive pacing technology available today, yet Nanostim offers physicians the same pacing therapy as a conventional pacemaker. Pacemakers are typically implanted in patients with bradycardia, where the heart beats too slowly. The device is said to have a nine-year lifespan at a 100-percent duty cycle, or more than 13 years at 50 percent pacing. The Nanostim device is implanted, without conventional surgery, via the femoral vein with a steerable catheter. This is a less-invasive approach than traditional pacemaker procedures that require more extensive surgery. Nanostim is designed to be fully retrievable, so it can be repositioned throughout the implant procedure and later retrieved if necessary. It is supported by the St. Jude Medical Merlin Programmer, which is also used to interrogate and program the company's other pacemakers and implantable cardioverter defibrillators.

Stephen Levy is a contributor to Qmed and MPMN.