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St. Jude Medical Presents Positive HeartMate PHP Trial Data

St. Jude Medical Inc.STJ recently announced positive results from the SHIELD I clinical study. The trial data affirmed the benefits of HeartMate PHP percutaneous Heart Pump for patients undergoing high-risk percutaneous coronary intervention (PCI). HeartMate PHP became part of St. Jude's portfolio following the recent buyout of Thoratec.

HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. Its expandable catheter technology can generate average blood flow of four to five liters in a minute.

The clinical trial met both endpoints for primary performance (freedom from hemodynamic compromise during PCI) and safety (a combination of major undesirable events). The SHIELD I study exhibited that HeartMate PHP is capable of maintaining steady hemodynamics during revascularization. In addition, researchers have pointed out that HeartMate PHP can be implanted in an extremely efficient and user-friendly way.

It is to be noted that HeartMate PHP has already gained CE Mark, on the back of encouraging data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark trial. In the U.S., benefits of the device are currently being assessed in the SHIELD II IDE clinical trial.

Recently, St. Jude received CE Mark for HeartMate 3 Left Ventricular Assist System (LVAS). The company will initially commercialize the product in limited markets, while an expanded launch is planned in 2016. Meanwhile, the clinical trial of 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 under the HeartMate III U.S. IDE clinical trial, which had commenced in Sep 2014.

Rollout of HeartMate 3 in European markets is expected to help St. Jude achieve greater traction, while positive HeartMate 3 and HeartMate PHP clinical data in the U.S. will open up additional 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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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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