Minnesota based Cardiovascular Systems revealed that it has received a PMA approval from the US Food and Drug Administration for its Diamondback 360 Coronary Orbital Atherectomy System (OAS) as a potential treatment for severely calcified coronary arteries.
The Diamondback 360 Coronary OAS safely reduces calcified lesions in coronary blood vessels with the help of an electrically driven 1.25 mm diamond-coated crown, thereby allowing for successful stent deployment, leading to more favorable patient outcomes.
According to recent studies, over 40 percent of patients who undergo percutaneous coronary intervention (PCI) suffer from significant arterial calcium which leads to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used.
"Severe coronary arterial calcium is an underestimated problem in medicine, with limited options for treatment. The ORBIT II trial proved our Diamondback technology is safe and effective in treating this complex disease. Securing coronary approval is another key milestone in our mission to provide primary tools for vascular intervention. I'm proud of our principal physician investigators and scientific teams. Together, with the CSI team we're excited to move forward to help a larger physician population treat these previously underserved patients", President and CEO of Cardiovascular Systems David L. Martin said.