FDA OKs PMA for Cardiovascular Systems’ System to Treat Calcified Coronary Artery Disease

Cardiovascular Systems Inc. received premarket approval from the U.S. Food and Drug Administration (FDA) for 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 CSI,” said David L. Martin, president and CEO of St. Paul, Minn.-based 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 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, which company officials estimate is in excess of $1.5 billion annually.

“Severe coronary arterial calcium is an underestimated problem in medicine, with limited options for treatment,” Martin added. “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.”

“Coronary calcium is undertreated in the cardiac cath[ether] 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 at Columbia University and director of Cardiovascular Research and Education Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical Center, and co-director of The Cardiovascular Research Foundation New York, N.Y.

ORBIT II was a 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 in history that sought approval for treating these lesions, according to company officials.

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. In addition, 92.8 percent of patients were free from severe angiographic complications, and core lab assessed final procedure residual blockage was 4.7 percent.

“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,” Chambers said. “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-millimeter diamond-coated crown to safely reduce calcified lesions in coronary blood vessels.

CSI will begin a controlled launch of the system immediately immediately.

“Our initial coronary rollout will be very targeted,” Martin said. “With a dedicated team of coronary sales specialists, we will focus on a limited number of the top medical institutions in the United States and continue that strategy for several quarters. 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 to enhance our product offering 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 one out of four people 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. 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. 

Cardiovascular Systems’ Orbital Atherectomy Systems treat calcified plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The FDA granted 510(k) clearance for the use of the Diamondback 360 Orbital Atherectomy System in August 2007 used to treat peripheral artery disease within the major and branch arteries of the leg.