Thoratec receives conditional FDA approval for the SHILED II US clinical trial for HeartMate PHP

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The US Food and Drug Administration (FDA) has granted conditional approval for a US investigational device exemption clinical trial to examine the use of Thoratec’s HeartMate PHP acute catheter-based heart pump in patients undergoing a high-risk percutaneous coronary intervention.

The SHIELD II (Supporting patients undergoing high-risk PCI using a high-flow percutaneous left ventricular support device) clinical trial will randomise up to 425 patients at up to 60 sites against the Impella 2.5 at a 2:1 ratio. Individual sites may immediately begin randomisation after performing a series of up to three HeartMate PHP procedures for purposes of training and familiarity. The primary endpoint will measure non-inferiority based on a composite of adverse events at 90 days of follow-up. Final FDA approval is expected in the coming months pending resolution of certain routine technical questions.

HeartMate PHP is an acute cardiac assist device designed to disrupt the traditional relationship between size and flow in catheter-based support devices. The proprietary expandable catheter technology of HeartMate PHP is capable of generating average blood flow of four to five litres per minute following delivery through a true percutaneous insertion. The device has also been designed for haemocompatibility, with operating RPMs of 17,000–20,000.

 

While conditional FDA approval allows for immediate start of the HeartMate PHP US clinical trial, enrolment is expected to begin during the third quarter of 2015 following site selection and training. Thoratec is also expecting CE mark approval for HeartMate PHP during the third quarter of 2015.

HeartMate PHP was featured in a live high-risk PCI case presented at the recent EuroPCR 2015 conference (19–22 May, Paris, France). “The HeartMate PHP demonstrated ease of deployment with an ability to provide stable haemodynamic support during this complex cardiac case. This exciting new technology has the potential to provide improved clinical outcomes to a large population of patients in need of acute circulatory assistance,” said Nicolas van Mieghem, the HeartMate PHP CE mark trial investigator who performed the case at Erasmus Medical Center in Rotterdam, Netherlands for live transmission to EuroPCR attendees.

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