First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

It didn’t take long for Cardiovascular Systems Inc.’s (CSI) orbital atherectomy technology to find its way to the operating room.

Mere weeks after receiving the CE Mark, the company’s Diamondback 360 Coronary Orbital Atherectomy System (OAS) was used by a doctor in The Netherlands to treat the first patient on the continent.  
 
“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 optimize stent performance. I’m confident European physicians will like this fascinating technology to help treat their patients with calcific coronary artery disease,” said Professor Nicolas Van Mieghem, director of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands, who successfully treated the first European patient.
 
Orbital atherectomy has demonstrated clinical advantages compared to historical rotational atherectomy data, including lower rates of target lesion revascularization 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 mid-January. Diamondback is approved by the U.S. Food and Drug Administration and has been sold in the United States since 2013.
 
Scott Ward, Chairman, president and CEO 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.”
 
Cardiovascular Systems Inc. is a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease.