Leadless Pacemaker Trial at Mercy

June 9, 2014

ST. LOUIS - For patients with heart rhythm issues, pacemakers are lifesavers. When the heart rate slows, pacemakers provide electrical stimulation to keep the heart pumping at an adequate rate.

Mercy Hospital St. Louis is the first and only in Missouri to implant the Nanostim™ leadless pacemaker as part of the LEADLESS II Clinical Trial. The device is the world’s first retrievable, non-surgical pacing technology. Developed for patients with bradycardia – a heart rate that is too slow – the Nanostim device is designed to be placed directly in a patient’s heart without the visible lump, scar and insulated wires (called leads) required for conventional pacemakers. 

The LEADLESS II pivotal trial is a prospective, non-randomized, multi-center, international clinical study designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in qualifying U.S. patients. The study is expected to enroll approximately 670 patients at 50 centers.

“The Nanostim is a huge development for patients with rhythm disorders,” said Amit Doshi, MD, Mercy Clinic Heart and Vascular electrophyiologist and principal investigator for the trial at Mercy. “It will eliminate many of the typical activity restrictions and ultimately allow our patients to get back to a more active life.”  

Implanted via the femoral vein with a steerable catheter, the Nanostim leadless pacemaker offers physicians at Mercy a less-invasive approach compared to traditional pacemaker procedures that require more extensive surgery. The small device is designed to be fully retrievable so it can be readily repositioned during the implant procedure and later retrieved, if necessary.

Dr. Doshi added, “Nanostim will serve a wide range of patient populations but will be especially helpful for patients who have had infection issues, have trouble with veins - like dialysis patients - and those who don’t need pacemakers with several different wires.”

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 size of the device along with the lack of a surgical pocket and wiring, improves patient comfort and can reduce complications, including device pocket-related infection and lead failure. 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).

Cardiac pacemakers monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. More than 4 million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.

The Nanostim leadless pacemaker received CE Mark approval in 2013 and is now available in select European markets. The device is not available for sale in the U.S. and is currently being implanted the U.S. by the FDA approved investigational study.

For more additional information on Nanostim pacemaker technology, visit sjm.com/leadlesspacing. Interested patients should call Mercy Cardiovascular Research at 314-251-3920.

HEC-TV Innovations takes a look at the new Nanostim technology.

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