FDA Approves First Coronary Orbital Atherectomy Device for Over 20 Years

A year ago we were reporting enrollment completion in its pivotal study. Now Cardiovascular Systems, Inc. (CSI) has received FDA PMA approval for its Diamondback 360® Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries.

Background

According to CSI’s press release, estimates suggest significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a substantially higher occurrence of death and major adverse cardiac events (MACE).

This is the unmet need at which CSI is pitching its Diamondback 360 Coronary OAS, with its electrically driven 1.25 mm diamond-coated crown which, it says, safely reduces calcified lesions in coronary blood vessels. This ultimately helps enable successful stent deployment, which facilitates more favorable patient outcomes.

FDA approval was based on CSI’s ORBIT II study, which evaluated the safety and effectiveness of the company’s orbital atherectomy technology in treating the problematic subset of patients with severely calcified coronary lesions. It is apparently the first study in history that sought approval for treating these lesions.

Led by Principal Investigator, Jeffrey Chambers, MD, of Metropolitan Heart and Vascular Institute, Minneapolis, the study delivered clinical outcomes that exceeded the trial’s two primary safety and efficacy endpoints by a significant margin—all within one of the most challenging patient populations.

At 30 days, ORBIT II results showed patient freedom from MACE was 89.8 percent and procedural success was 89.1 percent. Excluding in-hospital MACE, procedural success was 98.6 percent with 97.7 percent of stents successfully delivered. Moreover, 92.8 percent of patients were free from severe angiographic complications, and core lab assessed final procedure residual stenosis was 4.7 percent.

CSI will begin a controlled commercial launch of its Diamondback 360 Coronary OAS immediately.

Physician comments

“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,” said Dr. Gregg Stone, Professor of Medicine, Columbia University, Director of Cardiovascular Research and Education Center for Interventional Vascular Therapy New York Presbyterian Hospital/Columbia University Medical Center and Co-Director of The Cardiovascular Research Foundation New York, N.Y.

ORBIT II study Investigator Jeffrey Chambers said “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.”

Company comments

“Today is a landmark moment for patients suffering from calcified coronary artery disease, their families, our physician operators and everyone at CSI,” said David L. Martin, President and Chief Executive Officer of Cardiovascular Systems. “FDA approval of our Diamondback 360 Coronary OAS allows us to bring to market the first new coronary atherectomy system in more than two decades.”

“Severe coronary arterial calcium is an underestimated problem in medicine, with limited options for treatment. The ORBIT II trial proved our Diamondback technology is safe and effective in treating this complex disease. Securing coronary approval is another key milestone in our mission to provide primary tools for vascular intervention. I’m proud of our principal physician investigators and scientific teams. Together, with the CSI team we’re excited to move forward to help a larger physician population treat these previously underserved patients.”

Source: Cardiovascular Systems, Inc., Business Wire