Shares of St. Jude Medical Inc.STJ rose nearly 2.2% yesterday, following the CE Mark approval for HeartMate 3 Left Ventricular Assist System (LVAS) in Europe. The company will start to commercialize the product in limited markets for now, while it will be launched in additional markets in 2016.
HeartMate 3 is a next-generation continuous-flow left ventricular assist device (LVAD) based fully on magnetically levitated technology. The product became part of St. Jude's portfolio after the acquisition of Thoratec, which also brought in products and technologies like HeartMate 2 and HeartMate PHP.
HeartMate 3 received the CE Mark following positive data from the clinical trial. Results from the clinical study demonstrated six month survival rate of 92%, which is the highest to be recognized in an LVAD CE Mark clinical study till date.
It has to be noted that clinical trial for the product is being carried out in the U.S. In April this year, Thoratec received the final approval from the FDA to broaden enrollment of the HeartMate III U.S. IDE clinical trial, which commenced in Sep 2014.
Clinical trial in U.S. for HeartMate PHP has also been initiated last month. The SHIELD II U.S. clinical trial aims at exploring the use of HeartMate PHP in patients undergoing high-risk percutaneous coronary intervention (PCI). The product is already available in the European markets.
Rollout of HeartMate 3 in the European markets is expected to help St. Jude achieve greater market penetration, while positive clinical data for HeartMate 3 and HeartMate PHP in the U.S. will open up additional growth opportunities for St. Jude.
Zacks Rank and Key Picks
Currently, St. Jude carries a Zacks Rank #2 (Buy). Other favorably ranked stocks in the medical sector are Masimo MASI , Mazor Robotics MZOR and NuVasive NUVA . All the stocks sport a Zacks Rank #1 (Strong Buy).
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