Cardiovascular Systems, a US-based medical device company, has obtained a premarket approval from the US Food and Drug Administration (FDA) for its Diamondback 360 coronary orbital atherectomy system (OAS), designed to treat severely calcified coronary arteries.
Using an electrically driven 1.25mm diamond-coated crown, the Diamondback 360 coronary OAS reduces calcified lesions in coronary blood vessels and enables successful stent deployment.
The Diamondback 360 system's effectiveness is backed by the ORBIT II clinical data.
Cardiovascular Systems' ORBIT II study has been designed to assess the safety and effectiveness of its orbital atherectomy technology in treating the problematic subset of patients with severely calcified coronary lesions.
This study showed positive clinical outcomes in meeting primary safety and efficacy endpoints.
The ORBIT II study results at 30 days demonstrated patient freedom from major adverse cardiac events (MACE) was 89.8% and procedural success was 89.1%.
Excluding in-hospital MACE, procedural success was 98.6% with 97.7% of stents successfully delivered.
Additionally, 92.8% of patients were free from severe angiographic complications, and core lab assessed final procedure residual stenosis was 4.7%.
Cardiovascular Systems CEO David L Martin noted today is a landmark moment for: patients suffering from calcified coronary artery disease, their families, physician operators and everyone at CSI.
"FDA approval of our Diamondback 360 Coronary OAS allows us to bring to market the first new coronary atherectomy system in more than two decades.
"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," Martin added.
With the FDA premarket approval, the company will now initiate a controlled commercial launch of the Diamondback 360 Coronary OAS.
Image: Diamondback 360 coronary orbital atherectomy system Photo: Courtesy of Businesswire.
