UPDATE: Cardiovascular Systems closes enrollment in Diamondback trial
Cardiovascular Systems closes enrollment in a clinical trial of its Diamondback 360 Orbital atherectomy device for clearing calcium from clogged coronary arteries.
The catheter-delivered device uses a diamond-coated crown to remove occlusive material from constricted blood vessels. The Orbit II trial, which the St. Paul, Minn.-based medical device company hopes will back its pre-market approval application with the FDA for treating severely calcified coronary arteries, involved treatment with an earlier, pneumatically powered device and a newer electric model, according to a press release.
Another version of the Diamondback 360 device is already approved for treating peripheral artery disease.