Cardiovascular Systems announced that the US Food and Drug Administration (FDA) has approved the Diamondback 360 Coronary orbital atherectomy system (OAS) Micro Crown system to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
The Diamondback 360 Coronary OAS Micro Crown retains the novel mechanism of action of the Diamondback 360 Coronary OAS Classic Crown.
Both systems allow treatment of multiple vessel sizes with one device while providing continuous flow of blood during treatment, which is important for both acute and long-term success.
The OAS Micro Crown is the only device incorporating a diamond-coated tip to immediately engage and pilot through tight, severely calcified lesions that would otherwise be difficult to access, while also treating up to 4mm vessels with the same device.
The increased mass of the sanding crown allows for lower rotational speeds, while maintaining the same orbit diameter as the OAS Classic Crown.
“We are committed to continued advancement of CSI’s proven OAS technology focused on severe coronary arterial calcium, which is an underserved problem in vascular medicine,” said Scott Ward, Chairman, President and Chief Executive Officer of CSI.
“Patients with severely calcified coronary lesions are some of the most difficult to treat, leading to worse clinical and economic outcomes. The ORBIT II and COAST studies demonstrated that orbital atherectomy technology is safe and effective in treating patients with severely calcified lesions.”
COAST was a Harmonization-By-Doing clinical study for the OAS Micro Crown conducted in both the United States and Japan under the regulations of both governments.
COAST was led by U.S. National Principal Investigator, Gregg W. Stone, MD, of New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY, and Japan National Principal Investigator, Dr. Shigeru Saito, of Shonan Kamakura General Hospital, Kamakura City, Japan.
CSI’s Diamondback 360 Coronary OAS Classic Crown and Micro Crown are the first and only atherectomy devices approved in the U.S. to specifically treat severely calcified coronary arteries.
Since FDA approval of the OAS Classic Crown in October 2013, over 25,000 devices have been used to treat patients with CAD. The OAS Micro Crown will supplement the existing OAS Classic Crown product line offering in the U.S. A limited release of the OAS Micro Crown is expected to begin in the U.S. later this summer.
CAD is a life-threatening condition and a leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow.