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Thoratec Set To Begin U.S. Trial Of Catheter Heart Pump To Assist PCI

FDA has conditionally approved a 425-patient trial, called SHIELD II, comparing Thoratec's HeartMate PHP to Abiomed's Impella 2.5. The company expects the study to begin in the third quarter.

Thoratec Corp. expects its SHIELD II trial testing its HeartMate PHP catheter-based heart-pump in patients undergoing high-risk coronary interventions to begin enrolling patients at up to 60 U.S. sites in the third quarter of 2015.

The company announced May 26 that FDA has conditionally approved an investigational device exemption for SHIELD II and expects FDA to grant final approval in the "coming months pending resolution...

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