Posts Tagged ‘atherectomy’

November 6th, 2013

Perspective On the First New Atherectomy Device in 20 Years

The 2011 ACCF/AHA/SCAI PCI guidelines give rotational atherectomy (RA) a Class IIa LOE C recommendation as reasonable to use in cases where heavily calcified coronary lesions either cannot be crossed by a predilation balloon or if crossed cannot be adequately predilated prior to successful stent delivery. Furthermore, routine use of RA is Class III, contraindicated, […]

October 23rd, 2013

FDA Approves First New Atherectomy Device in 20 Years

The FDA on Tuesday granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS  was the first new coronary atherectomy system to receive FDA approval in two decades. The company said it would begin a controlled launch of […]

December 8th, 2010

The Spin on the Impella Device: PROTECTing Whom?


The PROTECT II study — a prospective, multicenter, randomized, controlled comparison of the Impella cardiac assist device (produced by Abiomed) and the intra-aortic balloon pump (IABP) in patients requiring hemodynamic support during nonemergent, high risk PCI — was stopped early based on a futility determination regarding the primary endpoint at the time of planned interim analysis. What’s […]