St. Jude Medical Inc. recently announced the receipt of CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for its Nanostim leadless pacemaker.
The approval will allow patients with a Nanostim leadless pacemaker in Europe to go through full-body MRI diagnostic scans in a more secure way. Notably, Nanostim pacemaker had obtained CE Mark approval in 2013.
The device is supported by the St. Jude Medical Merlin Programmer, used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs).
Globally, over 4 million people possess an implanted pacemaker or other cardiac rhythm management device, while 700,000 patients get the device each year. In a scenario like this, we feel the recent CE Mark will help St. Jude gain significant market traction. This will eventually bode well for the company’s top line.
Furthermore, the new approval expands the company’s portfolio of MRI compatible products. In December last year, St. Jude announced the CE Mark approval for magnetic resonance imaging (MRI) compatibility on its Quadra Assura Cardiac Resynchronization Therapy Defibrillator (CRT-D). Notably, the company gained CE Mark approval for the Quadra Assura MP CRT-D and Quadra Assura CRT-D in 2013 and 2012, respectively.
Last year, St. Jude received CE Mark approval for MRI conditional labeling for the company’s Prodigy MRI chronic pain system with select leads. Additionally, the company recieved CE Mark for expanded labeling of its Ellipse implantable cardioverter defibrillator, Assurity MRI and Endurity MRI pacemaker device families.
Zacks Rank & Key Picks
Currently, St. Jude has a Zacks Rank #4 (Sell). Better-ranked stocks in the medical instruments space are Abiomed (ABMD - Free Report) , CryoLife (CRY - Free Report) and Luminex (LMNX - Free Report) . All the stocks sport a Zacks Rank #1 (Strong Buy).
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