Cardiovascular Systems receives coronary FDA approval


Cardiovascular Systems announced that it has received 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. 

“Today is a landmark moment for patients suffering from calcified coronary artery disease, their families, our physician operators and everyone at Cardiovascular Systems,” 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.”

According to estimates, significant arterial calcium is present in nearly 40% 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 approval opens up a large US market opportunity for Cardiovascular Systems, estimated to exceed US$1.5 billion annually.

Martin adds, “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.”

“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 coronary artery disease interventions for this difficult-to-treat population, while improving long-term patient prognoses,” says 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, USA.

Clinical data backs systems’ effectiveness

ORBIT II is Cardiovascular Systems’ study evaluating 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 the first study, it states in a company press release, in history that sought approval for treating these lesions.

Led by principal investigator, Jeffrey Chambers, of Metropolitan Heart and Vascular Institute, Minneapolis, ORBIT II demonstrated that Cardiovascular Systems’ technology produced clinical outcomes that 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 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%.

According to Chambers, “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 Cardiovascular Systems’ orbital atherectomy technology is safe and effective. With FDA approval, physicians now have new technology to treat patients with severely calcified coronary lesions.”

The Diamondback 360 Coronary OAS uses an electrically driven 1.25mm diamond-coated crown to safely reduce calcified lesions in coronary blood vessels. This ultimately helps enable successful stent deployment, which facilitates more favourable patient outcomes, it says in the release.