MRI Compatibility CE Mark for St. Jude Medical Nanostim Leadless Pacemaker

With a new CE mark approval, St. Jude Medical, Inc. has now added magnetic resonance (MR) conditional labeling for 1.5 T scans for its Nanostim™ leadless pacemaker.

Background

MRI compatibility, or rather conditionality, is fast becoming a must for new implantable electronic devices. Now St. Jude Medical has achieved the milestone for its tiny Nanostim device, which is implanted via the femoral vein, using the smallest available leadless technology delivery system. The Nanostim leadless pacemaker offers a less-invasive approach for physicians compared to traditional pacemaker procedures that require more invasive 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.

With the new approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.

The latest approval builds upon the company’s portfolio of MRI compatible products, and furthers patient access to the technological benefits of the Nanostim leadless pacemaker, the world’s first commercially available retrievable leadless pacemaker.

Physician comments

“Providing my patients access to a highly advanced pacemaker that can undergo an MRI scan is a notable step forward in treatment options,” said Dr. Johannes Sperzel, head of the electrophysiology department at the Kerckhoff Klinik in Bad Nauheim, Germany.

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

Company comments

“The Nanostim leadless pacemaker is one of the most important advances in the history of pacemaker technology,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at 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.”

Source: St. Jude Medical, Inc

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