Credit: Shutterstock photoThoratec Corp.THOR recently announced the start of patient enrollment in the SHIELD II U.S. clinical trial, which aims at exploring the use of HeartMate PHP in patients undergoing high-risk percutaneous coronary intervention (PCI).
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 new clinical study will enroll 425 patients at about 60 sites across the country. The patients will then be treated at random with HeartMate PHP and Impella 2.5 pump in a 2:1 ratio. The primary endpoint will determine non-inferiority based on a range of undesirable events at 90 days of follow-up.
It is to be noted that in July, Thoratec received the CE Mark approval for the product which allows the company to sell the product in the EU and other countries. The approval was based on data gathered from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark trial.
The start of SHIELD II clinical study underscores a series of positive developments within the company's flagship HeartMate product line.
Earlier in July, Thoratec had announced that the first HeartMate III implant had been conducted via mini-thoracotomy. The company reported that the implant was undertaken as part of a European study that seeks to assess outcomes and complications of using less-invasive surgical placement through hemi-sternotomy and left thoracotomy techniques.
In Apr 2015, the ROADMAP study affirmed the benefits of Thoratec's HeartMate II LVAD in ambulatory heart failure patients. The company also presented positive data on its HeartMate II device from the ENDURANCE destination therapy trial.
Earlier in April, Thoratec received FDA approval to increase enrollment for its HeartMate III U.S. IDE clinical trial, which was initiated in September last year. With this approval, Thoratec can now expand the trial at up to cover 60 sites across the U.S. from the initial limited enrollment phase at 5 sites.
We feel positive clinical data from HeartMate II, HeartMate III and HeartMate PHP will drive substantial growth at Thoratec in the near future.
Zacks Rank & Other Key Picks
Currently, Thoratec sports a Zacks Rank #1 (Strong Buy). Other well-placed stocks in the medical sector include Masimo MASI , NuVasive NUVA and Cyberonics CYBX . All the stocks have a Zacks Rank #1.
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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.
