Approval was based on data from the 1st 30 patients enrolled in its Shield I CE mark trial, the Pleasanton, Calif.-based company said. Data from all 50 patients in the study is slated to be presented later this year, Thoratec said.
“The Shield I clinical experience demonstrated both the performance and ease of use of HeartMate PHP, which was able to safely maintain or improve the hemodynamic profile of severely ill patients undergoing complex revascularizations,” principal investigator Dr. Dariusz Dudek of the Krakow, Poland’s University Hospital said in a press release.
The HeartMate PHP can generate average blood flow of 4 to 5 liters per minute following delivery through a true percutaneous insertion, Thoratec said. The company’s European rollout of the device is planned to run through the balance of 2015 and 2016.
“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,” CEO Keith Grossman said in prepared remarks.
The HeartMate PHP is positioned to go head-to-head against Abiomed‘s (NSDQ:ABMD) Impella 2.5 device, with a U.S. trial comparing the 2 slated to enroll up to 425 patients at up to 60 sites after Thoratec won FDA investigational device exemption approval in May.
The company said it expects to begin enrolling patients in the U.S. trial of the device in the 3rd quarter this year.
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.