FDAnews Device Daily Bulletin

CSI Touts Benefits, Cost-Effectiveness of Diamondback 360 Coronary OAS

Feb. 26, 2014

Cardiovascular Systems said initial data from a pivotal study show the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for treatment of severely calcified lesions lowers stroke and heart attack risks and is cost-effective.

Presenting one-year data from the Orbit II study, CSI said the device had a low Major Adverse Cardiovascular Events rate of 16.4 percent, including 10 percent of patients who had a heart attack and 3 percent who died due to cardiac arrest. The study involved 443 patients at 49 U.S. medical centers.

The device also reduced hospital stays and resulted in fewer readmissions, saving in excess of $4,000 per patient, CSI said. The company discussed the findings at the 2014 Cardiovascular Research Technologies conference in Washington, D.C.

“Coronary arterial calcium is a significantly underserved and problematic condition, often resulting in poor outcomes and higher treatment costs,” said David Martin, CSI CEO. “The results shared at CRT show that our orbital atherectomy technology provides cost-effective and long-term durable outcomes for these difficult-to-treat patients.”

Jeffrey Chambers, Metropolitan Heart and Vascular Institute in Minneapolis, said the device gives physicians a new option to reduce coronary arterial calcium when inserting stents in the difficult-to-treat population.

Since gaining FDA 510(k) clearance in August 2007 for the treatment of peripheral artery disease, CSI has sold over 135,000 Diamondback 360 Coronary OAS. In October, the FDA cleared the system for use in coronary arteries. — Ferdous Al-Faruque

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