Cardiovascular Systems, Inc. announced that Samin K. Sharma, M.D., Director of Clinical and Interventional Cardiology at The Mount Sinai Medical Center, New York, N.Y., is the first physician in the United States to treat severely calcified coronary lesions using the revolutionary, new Diamondback 360 ® Coronary Orbital Atherectomy System (OAS). The Diamondback 360 Coronary OAS uses a patented combination of differential sanding and centrifugal force to reduce arterial calcium that can cause complications when treating coronary artery disease (CAD). The system gained U.S. Food and Drug Administration (FDA) approval on October 21, 2013, and is the first and only technology approved for the treatment of severely calcified coronary lesions.
Cardiovascular Systems’ revolutionary, new Diamondback 360(R) Coronary Orbital Atherectomy System was recently approved by the U.S. Food and Drug Administration to treat severely calcified lesions in coronary arteries. (Photo: Business Wire) “Finally, there is a technology on the market to specifically address the challenge we face in treating severely calcified coronary lesions,” said Sharma. “The ease of performing orbital atherectomy with the Diamondback device should help to treat patients with severe coronary calcium that might have otherwise been overlooked due to the complexity of other technologies. I believe Orbital Atherectomy could potentially be used in at least 10 percent of PCI patients going forward.” The Diamondback 360 Coronary OAS is an eccentrically mounted 1.25-millimeter diamond-coated crown that sands away calcium in coronary arteries, enabling stent deployment. As the crown rotates and orbit increases, centrifugal force presses the crown against the lesion, reducing arterial calcium.
Thirty-day data from CSI’s ORBIT II clinical study demonstrated that the Diamondback 360 Coronary OAS technology produced clinical outcomes that exceeded the trial’s two primary endpoints (safety and efficacy) by a significant margin. The 30-day freedom from major adverse cardiac events (MACE) rate was 89.6 percent and the primary effectiveness was 88.9 percent, including MACE. Furthermore, 97.7 percent of stents were successfully delivered and core lab assessed final procedure residual stenosis was 4.7 percent. The study included 443 patients at 49 U.S. medical centers and supported CSI’s Premarket Application (PMA) submission. ORBIT II was the first Investigational Device Exemption (IDE) study in history to support approval for treating severely calcified coronary lesions.
“CSI’s OAS technology is extremely promising, the unique orbital mechanism of action prepares the severely calcified coronary lesions for successful stent deployment,” said Sharma. “In addition to the impressive results of the ORBIT II study, data from the ORBIT I pilot study demonstrated positive results for the treatment of calcified coronary lesions.” Approximately 16.3 million Americans suffer from Coronary Artery Disease (CAD). Arterial calcium is a common occurrence and can lead to significant complications. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention.
The Diamondback 360 ® Coronary OAS is approved by the FDA. For more information, please visit www.csi360.com or call 877-274-0901.
