February 6, 2014 — The first U.S. implant was announced for St. Jude Medical’s LEADLESS II pivotal trial, designed to evaluate the Nanostim leadless pacemaker for U.S. Food and Drug Administration (FDA) approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Vivek Reddy, M.D.
The Nanostim leadless pacemaker is designed to be placed directly in the heart without the visible surgical pocket, scar and leads required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device offers physicians the same pacing therapy through a less-invasive approach as compared to traditional pacemaker procedures that require more extensive surgery. The device is designed to be fully retrievable, so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.
“This clinical research trial will be testing the latest innovative, non-surgical pacemaker option for U.S. patients experiencing heart rhythm issues,” said the study’s co-investigator Dr. Vivek Reddy, director of electrophysiology services at The Mount Sinai Hospital and chairman of the steering committee of the study. “This new-age, tiny pacemaker may ultimately be safer for patients because it doesn’t have leads or have to be inserted under the skin of a patient’s chest, like a traditional cardiac pacemaker. I look forward to the results of the LEADLESS II clinical trial.”
The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and is the least invasive pacing technology available today. The small size of the device and lack of a surgical pocket, coupled with the exclusion of a lead, aims to improve patient comfort and may reduce complications, including device pocket-related infection and lead failure. 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 are routinely put in place in an attempt to prevent 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).
The LEADLESS II pivotal trial is a prospective, non-randomized, multi-center, international clinical research trial designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in patients indicated for the device. It is being conducted under an Investigational Device Exemption (IDE) from FDA, and will enroll approximately 670 patients at 50 centers in Canada, Europe and the United States.
Initial results from the LEADLESS study were presented last year and demonstrated overall device performance comparable to conventional pacemakers. Total implant procedure times averaged 28 minutes. 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 Nanostim pacemaker received CE marking in 2013 and is available in select European markets. The device is not available for sale in the United States.
For more information: www.sjm.com
March 26, 2024 
