The Shield II trial is slated to enroll up to 425 patients at up to 60 sites, randomized against the Impella device at a 2:1 ratio. The trial’s primary endpoint is non-inferiority based on a composite of adverse events at 90 days. It’s being led by co-principal investigators Dr. Ulrich Jorde of New York’s Montefiore Medical Center, Dr. David Kandzari of Atlanta’s Piedmont Heart Institute and Dr. Navin Kapur of Boston’s Tufts University Medical Center.
HeartMate PHP won CE Mark approval in the European Union in July, based on data from the 1st 30 patients enrolled in its Shield I trial. Thoratec said its special sauce is a proprietary expandable catheter “capable of generating average blood flow of 4 to 5 liters per minute following delivery through a true percutaneous insertion.”
“Shield II marks the beginning of our clinical experience with PHP in the large and important U.S. market,” president & CEO Keith Grossman said in prepared remarks. “We look forward to the significant clinical data expected from Shield II and the ultimate commercialization of PHP in the U.S.”
Abiomed won pre-market approval from the FDA for its flagship Impella 2.5 in March, after the FDA’s Circulatory Devices panel recommended in late 2012 that percutaneous cardiac assist devices be subject to the FDA’s most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA’s less-stringent 510(k) clearance protocol.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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