St Jude Medical has received conformité européenne (CE) mark approval for magnetic resonance (MR) conditional labelling for 1.5T scans of its Nanostim leadless pacemaker.
The approval allows existing and new patients implanted with a Nanostim leadless pacemaker to safely undergo full-body MRI diagnostic scans in the future.
The company noted that the latest approval builds upon its portfolio of MRI-compatible products, and furthers patient access to the technological benefits of the Nanostim leadless pacemaker.
Royal Brompton Hospital cardiologist and electrophysiologist Dr Tom Wong said: "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 labelling provides that flexibility and will be of great benefit to patients to ensure peace of mind for the future."
The new pacemaker, which is 10% smaller compared to conventional pacemakers, has been designed to be implanted directly in the heart without the need for a surgical pocket or lead.
St Jude Medical global clinical vice-president and chief medical officer Dr Mark Carlson said: "The Nanostim leadless pacemaker is one of the most important advances in the history of pacemaker technology.
"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."
The Nanostim leadless pacemaker can be implanted through the leadless technology delivery system, as well as readily repositioned throughout the implant procedure, as it is fully retrievable.
Supported by St Jude Medical’s Merlin Programmer, the new pacemaker can also be used to interrogate and programme the company’s other pacemakers and implantable cardioverter defibrillators (ICDs).
In October 2013, the company secured the CE mark for its Nanostim leadless pacemaker, and is currently undergoing a clinical trial in the US under an FDA-approved investigational device exemption.
Last September, St Jude Medical received CE mark approval for its new Infinity Deep Brain Stimulation (DBS) system and directional DBS lead.
Image: St. Jude Medical’s Nanostim leadless pacemaker is now MRI compatible. Photo: courtesy of Business Wire.