First UK Patient for Tiny Leadless Nanostim™ Pacemaker

St. Jude Medical, Inc. is trumpeting the first post-approval implant of the Nanostim™ leadless pacemaker in the U.K. The world’s first retrievable leadless pacemaker was implanted at St. Bartholomew’s Hospital in London, UK, by Professor Richard Schilling.

Background

Last October we covered the news that St.Jude had acquired the Nanostim leadless and tiny pacemaker. At less than 10 percent the size of a conventional pacemaker, 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 a less-invasive approach and is designed to be fully retrievable so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.

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 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 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).

The recipient of the device was 77 year old persistent atrial fibrillation sufferer, Maureen McCleave, who is reportedly already feeling more energetic and looking forward to a full recovery following the eight minute procedure (rather less than the 28 minute average recorded during the company’s so-called LEADLESS study.

Physician comments

“Nanostim is one of the most significant advancements in cardiology and pacemaker technology,” said Professor Schilling, consultant at Barts Health NHS Trust. “This miniaturized, minimally-invasive cardiac pacemaker offers my patients the potential for reduced complications like infection and aesthetic benefits over conventional pacemakers, in addition to quicker recovery times. We are delighted to have conducted the first implants of this ground-breaking technology at St. Bartholomew’s Hospital in the U.K.”

Company comments

“The first post-approval implant in the U.K. is an important step for this revolutionary technology platform and a proud addition to St. Jude Medical’s strong history in pacing innovation,” said Paul Turner, vice president of St. Jude Medical U.K. “By providing a smaller, leadless pacing technology, physicians will now be able to offer patients a device that upholds the accuracy of conventional pacemaker technology via a minimally invasive procedure. We are pleased to offer this novel cardiac pacing technology to physicians and patients in the U.K.”

Regulatory status

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

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

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