Thoratec Receives CE Mark Approval for its HeartMate PHP™ Pump - Report on Thoratec Corp.

Jul 29, 2015, 09:20 ET from www.aciassociation.com

NEW YORK, July 29, 2015 /PRNewswire/ --

ACI Association has initiated research coverage on Thoratec Corp. (NASDAQ: THOR). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.

Today, membership is open to readers on a complementary basis at the following URL: http://www.aciassociation.com/?c=THOR

Highlights from our THOR Report include:

  • HeartMate PHP Meets Requirements of European Community Directives - In its press release dated July 13, 2015, Thoratec Corporation (Thoratec) reported that its HeartMate PHP (Percutaneous Heart Pump) product has received CE Mark approval, thereby enabling the product's sale in the European Union and other international countries. Thoratec informed that HeartMate PHP is an acute cardiac assist device which is designed to uncouple the traditional relationship between size and flow in catheter-based support devices.
  • Clinical Trial's Primary Objective -As per the Company, the approval was based on data findings from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark trial. The primary objective of the trial was to evaluate the use of PHP to support patients going through from a high-risk PCI (percutaneous coronary intervention) procedure. As per the release, data from all 50 patients enrolled in the study will be presented later in 2015.
  • Commercialization Opportunity - Commenting upon the PHP's commercial acceptance and growth outlook, D. Keith Grossman, President and CEO stated that, "PHP is an entirely new opportunity for Thoratec.  Although the current catheter pump market outside the U.S. is relatively small, we look forward to gaining valuable clinical and commercial experience through a targeted European launch of HeartMate PHP in the coming months." Further, Thoratec intends to roll out HeartMate PHP in target markets through the rest of 2015 and 2016.
  • Other Clinical Trials on Track - On July 13, 2015, Cardiac Interventions Today, reported that Thoratec has recently received unconditional approval from the FDA for SHIELD II United States device exemption clinical trial and is expected to begin enrollment during the third quarter. In its earlier release dated July 6, 2015, Thoratec announced that the first HeartMate 3™ implant had been conducted via mini-thoracotomy. The Company reported that the implant starts a European study that seeks to assess outcomes and complications of using less invasive surgical placement through hemi-sternotomy and left thoracotomy techniques.

To find out how this influences our rating on Thoratec Corp., read the full report in its entirely here: http://www.aciassociation.com/?c=THOR

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