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ST. JUDE MRI SECURES CE MARK COMPATIBILITY APPROVAL.

St. Jude Medical, Inc. has received a CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company's Nanostim leadless pacemaker. With the 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.

More than 4 million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year. The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and designed to be implanted directly in the heart without the need for a surgical pocket or lead. 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.

Implanted via the femoral vein with 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.

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).

In the coming months, St. Jude Medical anticipates updated labeling for many of its existing cardiac rhythm management devices, which will allow more patients the freedom to safely undergo MRI scans.

About the Nanostim Leadless Pacemaker

A pacemaker is a small implantable device that sends electrical pulses to the heart to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. Leadless pacemakers provide the same type of therapy but do so without the traditional leads found in conventional pacemakers.

The Nanostim leadless pacemaker operates like a traditional pacemaker, but is 10 percent the size of a conventional pacemaker and is designed to reduce or eliminate complications associated with leads, chest incisions and surgical pockets. The Nanostim leadless pacemaker received CE Mark approval in October 2013. To date, more than 1,000 Nanostim leadless pacemakers have been implanted worldwide. The Nanostim leadless pacemaker is undergoing a clinical study in the U.S. under an FDA-approved investigational device exemption.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer and is dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world.

Headquartered in St. Paul, Minn., St. Jude Medical has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management, and cardiovascular.

For more information, visit www.sjm.com or call 651/756-4347.
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Publication:Biotech Equipment Update
Date:Mar 31, 2016
Words:558
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