European Post-Approval Trial for St. Jude's Leadless Pacemaker Begins
St. Jude Medical, Inc., 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 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.
The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and is the least invasive pacing technology on the market today. The small size of the device and lack of a surgical pocket, coupled with the exclusion of a lead, improves patient comfort and can reduce traditional pacemaker complications, including device pocket-related infection and lead failure. The device battery is expected to have an average lifespan of more than nine years at 100 percent pacing, or more than 13 years at 50 percent pacing.
The elimination of the visible lump and scar at a conventional pacemaker’s implant site, in addition to the removal of patient activity restrictions that may prevent the dislodgement or damage to a conventional lead, will potentially improve the quality of life for patients with this technology by allowing most to continue living active, uninhibited lifestyles. The device 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 (ICDs).
“Nanostim pacemaker technology is one example of St. Jude Medical’s commitment to helping physicians improve health outcomes across the globe,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “Our European clinical trial aims to further demonstrate how the Nanostim pacemaker improves patient outcomes and implant procedure efficiency through its minimally-invasive design. We are delighted to see this groundbreaking technology enable physicians to improve the lives of patients worldwide.” Cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. More than four million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.
Additional Nanostim Clinical Trials Initial results from the LEADLESS study, a prospective, single-arm, multicenter study evaluating patients with the Nanostim leadless pacemaker, were presented last year and demonstrated overall device performance comparable to conventional pacemakers. Total implant procedure times averaged 28 minutes.
The first U.S. implant in the LEADLESS II pivotal trial, designed to evaluate the Nanostim leadless pacemaker for U.S. Food and Drug Administration (FDA) approval, took place in February 2014. The trial is being conducted under an Investigational Device Exemption (IDE) from the FDA, and will enroll approximately 670 patients at up to 60 centers worldwide with up to 50 sites in the U.S.