St. Jude Medical Inc.STJ recently announced the receipt of CE Mark approval for expanded labeling of its Ellipse implantable cardioverter defibrillator (ICD) in Europe. The company also announced the CE Mark receipt for its Assurity MRI and Endurity MRI pacemaker device families, further expanding its MRI-conditional device portfolio in Europe.
In addition to Durata and Optisure defibrillation leads, Ellipse ICD with this CE Mark, will allow existing or future patients to undergo magnetic resonance imaging (MRI) scans without compromising on device performance.
The Ellipse device, designed to offer patients added protection in the event of a life-threatening arrhythmia, is among the smallest and most advanced ICDs today. In addition, St. Jude Medical's Assurity MRI and Endurity MRI devices are the world's smallest, longest-lasting wireless pacemakers available to patients today.
While the Ellipse, Assurity and Endurity devices are proven cardiac rhythm management technologies, St. Jude Medical has made them available in the MRI environment as well. By integrating advanced MRI-compatible technologies into these devices, St. Jude Medical intends to provide patients with cardiac devices access to this important diagnostic tool without compromising on device performance.
In the coming months, St. Jude Medical anticipates updated labeling for many of its existing cardiac rhythm management (CRM) devices, which will allow more patients to safely undergo MRI scans.
Additionally, St. Jude Medical is planning to submit test data in key markets around the world in 2015 for MRI conditional labeling on additional existing high-voltage products including the Fortify Assura ICD, Quadra Assura CRT-D and Quartet LV leads. The launch of several new CRM products in all major markets, including the U.S., Japan and Europe, in the second half of this year will strengthen the company's CRM business.
We believe that St. Jude Medical's expanding and innovative product portfolio will drive growth in 2015. However, as the company increases its exposure to international markets, foreign exchange volatility will weigh on its top line.
We note that per management's latest financial guidance, foreign exchange volatility is expected to negatively impact sales by approximately $125-$135 million in the second quarter of 2015 and by approximately $385-$410 million for full-year 2015.
Stocks to Consider
Currently, St. Jude Medical carries a Zacks Rank #3 (Hold).
Better-ranked stocks in the medical products industry include Bio-Rad Laboratories Inc. BIO , Hospira Inc. HSP and Vascular Solutions Inc. VASC . All the three stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report