First US Patient Receives Nanostim™ Non-Surgical, Leadless Cardiac Pacemaker

St. Jude Medical, Inc. has announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker on its way to U.S. FDA approval.

Background

Cardiac pacemakers are used to treat bradycardia, monitoring the heart and providing electrical stimulation when the heart beats too slowly for each patient’s specific physiological requirements.

Recently acquired by St. Jude, 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, improves 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, allow most to continue living active, uninhibited lifestyles.

The Nanostim device 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, making it a world first of its kind. It can be readily repositioned throughout the implant procedure and later retrieved if necessary.

Physician comments

The implantation was performed at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy, study coordinator of the LEADLESS II trial, who stated; “This clinical research trial will be testing the latest innovative, non-surgical pacemaker option for U.S. patients experiencing heart rhythm issues. 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 believe this pioneering, compact device, which is placed directly inside the heart, may be a true game-changing technology in cardiovascular medicine and may help revolutionize care for patients with arrhythmias. I look forward to the results of the LEADLESS II clinical trial.”

Company comments

“Since the introduction of the first implantable pacemaker in 1958, pacemaker technology has continued to evolve into smaller, more efficient devices,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “Despite this evolution, pacing technology has, until now, required surgery in addition to leads that connect the pacemaker to the heart. The Nanostim leadless pacemaker is the first miniaturized device that removes the need for leads, thus offering less invasive and less complicated procedures for physicians and patients around the world. We believe the innovative nature of this technology will change the future landscape of cardiac rhythm management devices by revolutionizing the delivery methods and design of these life-saving technologies.”

Regulatory status

The Nanostim pacemaker received CE Mark approval in 2013 and is available in select European markets. The device is not available for sale in the U.S.

Source: St.Jude Medical, Inc., Business Wire

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