Nanostim Leadless Pacemakers Approved for MRI

The St. Jude Medical (SJM; St. Paul, MN, USA) Nanostim leadless pacemaker is just 10% the size of a conventional pacemaker, and is designed to be implanted directly in the heart, reducing or eliminating common complications associated with leads, chest incisions, and surgical pockets. It is implanted via a percutaneous coronary intervention (PCI) through the femoral vein into the heart, using a miniature delivery system, and is designed to be fully retrievable for repositioning throughout the procedure, and later retrieved if necessary.

The device is supported via the proprietary Merlin Programmer, which is also used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs). Eliminating 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, could potentially improve the quality of life for patients and allow most to continue living active, uninhibited lifestyles.

“The Nanostim leadless pacemaker is one of the most important advances in the history of pacemaker technology,” said Mark Carlson, MD, vice president of global clinical affairs and chief medical officer of St. Jude Medical. “The freedom from leads and now the ability for patients with the Nanostim leadless pacemaker to undergo MRI scans are important factors for physicians as they consider treatment options.”

“It’s important that my patients in need of pacemakers also have the freedom to undergo MRI diagnostic scans for other conditions, if needed,” commented cardiologist and electrophysiologist Tom Wong, MD, of Royal Brompton Hospital (London, United Kingdom). “This new labeling provides that flexibility and will be of great benefit to patients to ensure peace of mind for the future.”

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