St. Jude Medical has received CE mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for its Nanostim leadless pacemaker.


The approval allows patients implanted with a Nanostim leadless pacemaker to undergo full-body MRI diagnostic scans.

Nanostim leadless pacemaker, which is 10% less in size compared to conventional pacemaker, 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 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."

Nanostim 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 Nanostim can also be used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs).

In October 2013, the company obtained CE mark approval for Nanostim leadless pacemaker, and is 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.

The Infinity DBS system, which is available in two sizes, is claimed to be the only upgradeable DBS system available to patients combating movement disorders.

Image: St. Jude Medical’s Nanostim leadless pacemaker is now MRI compatible. Photo: courtesy of Business Wire.