CSI’s Diamondback 360 Coronary Orbital Atherectomy System Approved in Europe

January 18, 2021—Cardiovascular Systems, Inc. (CSI) announced today that it has received European CE Mark approval for its Diamondback 360 coronary orbital atherectomy system (OAS) and ViperWire Advance coronary guidewire with Flex Tip.

According to CSI, the Diamondback 360 coronary OAS combines differential sanding and pulsatile forces to treat all calcium modalities, including nodular, eccentric, and concentric. The device features CSI’s GlideAssist, which allows for tracking, easier removal, and smoother repositioning of the device, particularly in challenging anatomies.

In the United States, the percutaneous Diamondback 360 coronary OAS has received FDA approval and is indicated to facilitate stent delivery in patients with coronary artery disease who are acceptable candidates for percutaneous transluminal coronary angioplasty or stenting due to de novo, severely calcified coronary artery lesions.

“Interventional cardiologists are increasingly treating older patients with more complex coronary disease,” commented Professor Michael Haude, MD, Director of Medical Clinic, Stadtische Kliniken in Neuss, Germany, in CSI’s announcement. “Calcific coronary disease is more prevalent in older patients and those who are smokers or have diabetes or renal dysfunction. We estimate 12% of percutaneous coronary intervention (PCI) patients present with significant calcific coronary disease. For those patients, PCI is associated with a higher risk of procedural complications, as well as poorer long-term results. As clinicians, we are eager to adopt new tools that can improve treatment and outcomes for these patients.”

Professor Nicolas Van Mieghem, MD, added, “Calcific coronary artery disease creates a significant challenge to achieving the optimal stent placement needed for best PCI outcomes. By treating all types of calcium, including superficial and deep calcium, the Diamondback 360 coronary OAS provides one unique solution to optimize stent delivery, expansion, and wall apposition to safely support procedural outcomes and ensure long-term clinical results, also in highly complex anatomies. I am excited to add orbital atherectomy to the treatment options for my patients.” Prof. Van Mieghem is Director of Interventional Cardiology at Thoraxcenter, Erasmus University Medical Center in Rotterdam, The Netherlands.