Thoratec Set To Begin U.S. Trial Of Catheter Heart Pump To Assist PCI
This article was originally published in The Gray Sheet
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.
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The company plans a targeted roll-out of its heart pump in select European markets following a CE mark for the device, indicated to help stabilize patients during high-risk percutaneous coronary interventions.
The approval, the first for a percutaneous hemodynamic support device, frees Abiomed's hand to market the miniature blood pump to a relatively broad patient population, analysts note.
Thoratec reported a near 10 percent year-over-year decline in revenue in the second quarter; physicians have become more selective about which patients to implant with a HeartMate II ventricular assist device, the firm says. The company is looking to next-generation of HeartMate products as well as the technology it acquired in the Apica deal to help it return to growth.