Diamondback 360 atherectomy system gains CE mark

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Diamondback 360 Coronary Orbital Atherectomy System (Cardiovascular Systems)

Cardiovascular Systems has received the CE mark for its Diamondback 360 coronary orbital atherectomy system (OAS) and ViperWire Advance coronary guide wire with flex tip (ViperWire Advance with Flex Tip).

Diamondback combines differential sanding and pulsatile forces to treat all calcium modalities, including nodular, eccentric (irregular) and concentric (ring-shaped). This device also features GlideAssist, which allows for tracking, easier removal and smoother repositioning of the device—particularly in challenging anatomies.

Michael Haude, Stadtische Kliniken, Neuss, Germany, EAPCI past-president and former PCR Board member, said: “Interventional cardiologists are increasingly treating older patients with more complex coronary disease. 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.”

Nicolas Van Mieghem, Director of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands, 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 optimise 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.”

Scott Ward, Chairman, President and Chief Executive Officer of Cardiovascular Systems, concluded: “Europe represents a large, underpenetrated market where coronary atherectomy is currently underutilised for the treatment of complex cardiovascular disease. We look forward to collaborating with European physicians to expand the treatment options for patients with severely calcified coronary artery disease.”


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