FDA Approves CSI's Diamondback 360 Coronary Orbital Atherectomy System

October 22, 2013—Cardiovascular Systems, Inc. (CSI; St. Paul, MN) announced that it has received premarket approval from the US Food and Drug Administration (FDA) to market its Diamondback 360 coronary orbital atherectomy system (OAS) as a treatment for severely calcified coronary arteries. CSI will begin a controlled commercial launch of the device immediately. The company also noted it will conduct postmarket studies of the device.

According to CSI, the Diamondback 360 coronary OAS uses an electrically driven, 1.25-mm, diamond-coated crown to safely reduce calcified lesions in coronary blood vessels. This helps enable successful stent deployment during percutaneous coronary interventions to facilitate more favorable patient outcomes.

In the company's press release, Gregg Stone, MD, commented, “Coronary calcium is undertreated in the cardiac cath lab. Having a user-friendly device available to effectively treat severe coronary calcium may increase the safety of CAD interventions for this difficult-to-treat population while improving long-term patient prognoses.” Dr. Stone is co-director of the Cardiovascular Research Foundation in New York, New York.

FDA approval of the Diamondback 360 OAS was supported by the company's ORBIT II trial, which demonstrated the Diamondback technology is safe and effective in treating severely calcified coronary arteries.

The company stated that ORBIT II's clinical outcomes exceeded the trial's two primary safety and efficacy endpoints by a significant margin—within one of the most challenging patient populations. At 30 days, ORBIT II results showed patient freedom from major adverse cardiac events (MACE) was 89.8% and procedural success was 89.1%. Excluding in-hospital MACE, procedural success was 98.6%, with 97.7% of stents successfully delivered. Moreover, 92.8% of patients were free from severe angiographic complications, and core-lab-assessed final procedure residual stenosis was 4.7%.

ORBIT II Principal Investigator Jeffrey Chambers, MD, presented the pivotal 30-day data in March 2013 at the 62nd annual scientific session of the American College of Cardiology in San Francisco, California. Dr. Chambers is affiliated with the Metropolitan Heart and Vascular Institute in Minneapolis, Minnesota.

In the company's announcement of FDA approval, Dr. Chambers commented, “Patients who suffer from severely calcified coronary lesions are one of the toughest-to-treat populations—and previous studies have shown these patients have worse outcomes. Thirty-day ORBIT II results demonstrate that CSI's orbital atherectomy technology is safe and effective. With FDA's approval, physicians now have new technology to treat patients with severely calcified coronary lesions.” In August 2007, the FDA cleared CSI's Diamondback peripheral orbital atherectomy system to treat calcified and fibrotic plaque in arterial vessels throughout the leg.