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FDA approves orbital atherectomy system for calcified coronary lesions
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Cardiovascular Systems, Inc. announced that it has received premarket approval of the Diamondback 360 Coronary Orbital Atherectomy System for the treatment of severely calcified coronary arteries.
The system reduces calcified lesions in the coronary arteries by using an electrically driven 1.25-mm diamond-coated crown, which helps enable successful stent deployment, according to a press release.
Approval of the orbital atherectomy system marks the first new device of its kind in more than 20 years, according to the release.
The approval follows results from the ORBIT II trial, which assessed the safety and efficacy of the device in patients with severely calcified lesions in the coronary artery. The procedure was successful in 89.1% of patients 30 days after treatment, with 89.8% of participants experiencing no major adverse cardiac events. Procedure success was observed in 98.6% of those who did not develop MACE in the hospital, with successful stent delivery in 97.7%. Almost 93% of patients did not experience severe angiographic complications, and researchers reported core lab assessed final procedure residual stenosis of 4.7%.
Gregg W. Stone
A controlled commercial launch of the orbital atherectomy system will begin immediately, with an initial focus on top medical institutions throughout the United States. The company also plans to conduct postmarket analysis of the system in order to obtain additional clinical data, according to the release.
“Coronary calcium is undertreated in the cardiac cath lab,” Gregg W. Stone, MD, director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical Center in New York, stated in the release. “Having a user-friendly device available to effectively treat severe coronary calcium may increase the safety of CAD interventions for this difficult-to-treat population, while improving long-term patient prognoses.”