Cardiovascular Systems Receives Coronary FDA Approval

Cardiovascular Systems Inc. (CSI) has been given the go-ahead from the U.S. Food and Drug Administration to market its Diamondback 360 Coronary Orbital Atherectomy System (OAS) treatment device for severely calcified coronary arteries.

“This is a landmark moment for patients suffering from calcified coronary artery disease, their families, our physician operators and everyone at CSI,” President/CEO David L. Martin said. “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 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 approval opens up a large, underserved U.S. market opportunity for CSI, estimated to exceed $1.5 billion annually.

“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,” Martin said. “Securing coronary approval is another key milestone in our mission to provide primary tools for vascular intervention. We’re excited to move forward to help a larger physician population treat these patients.”

“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 Gregg Stone, M.D., 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 in New York, N.Y.

ORBIT II is CSI’s study evaluating the safety and effectiveness of the company’s orbital atherectomy technology in treating the subset of patients with severely calcified coronary lesions. It is the first study in history that sought approval for treating these lesions.

Led by principal investigator Jeffrey Chambers, M.D., of the Metropolitan Heart and Vascular Institute in Minneapolis, Minn., ORBIT II demonstrated that CSI’s 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 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.

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 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.”

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 ultimately helps enable successful stent deployment, which facilitates more favorable patient outcomes.

Martin said the company’s rollout of the OAS will be targeted.

“We will focus on a limited number of the top medical institutions in the United States and continue that strategy for several quarters,” he noted. “During that time, we’ll focus on providing physicians with a quality experience and on driving adoption in those accounts. Additionally, we’ll conduct post-market studies and further build our body of clinical data.”

Coronary Artery Disease (CAD) is a life-threatening condition and leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease.

CAD affects an estimated 16.8 million people in the United States and is the most common form of heart disease. Heart disease claims more than 600,000 lives, or 1 in 4 Americans, in the United States each year. According to estimates, 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 significantly higher occurrence of death and major adverse cardiac events (MACE).

Cardiovascular Systems Inc., based in St. Paul, Minn., developing and commercializing solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified plaque in arterial vessels throughout the leg and heart.