Cardiovascular Systems has announced that the first patient in Europe has been treated with its Diamondback 360 coronary orbital atherectomy system (OAS).
Nicolas Van Mieghem, director of interventional cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands, who successfully treated the first European patient, said: “Patients with calcific coronary artery disease have poor clinical results. Diamondback 360 coronary OAS streamlines treatment with a unique mechanism to successfully modify severe calcium and optimise stent performance. I’m confident European physicians will like this fascinating technology to help treat their patients with calcific coronary artery disease.”
Orbital atherectomy has demonstrated clinical advantages compared to historical rotational atherectomy data, including lower rates of target lesion revascularisation and persistent slow flow/no reflow. CSI’s ORBIT II and COAST clinical studies demonstrated that OAS is safe and effective in treating patients with de novo severely calcified coronary lesions. Two real-world studies with approximately 1000 patients have reinforced Diamondback’s safety, high procedural success and long term clinical success.
CSI received CE mark for the Diamondback 360 Coronary OAS in January 2021. Diamondback is US Food and Drug Administration (FDA) approved and has been sold in the USA since 2013.
Scott Ward, chairman, president and chief executive officer of CSI, said: “We are excited to announce the first commercial use of the Diamondback 360 coronary OAS in Europe. The introduction of this device gives physicians in Europe an effective treatment option for this difficult-to-treat patient population. We are prepared to launch the product leveraging streaming platforms to train and support physicians and their cath lab teams remotely until travel may resume.”