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Cardiovascular Solutions won FDA approval for its Diamondback 360 system.–Courtesy of Cardiovascular Solutions

Cardiovascular Systems ($CSII) has won FDA approval to sell its Diamondback 360 device for patients with calcified coronary arteries, a long-awaited signoff that gives the company a chance to serve a large unmet need and significantly expand the market for its technology.

Diamondback 360 is an orbital atherectomy system designed to get rid of arterial calcium buildups in vessels before stenting, improving outcomes for patients and slashing rates of major adverse cardiac events, the company said. The device has been FDA-cleared to treat calcified plaque in arterial vessels throughout the leg and heart since 2007, and now approval for coronary lesions exposes Cardiovascular Systems to a $1.5 billion market dominated by last-generation technologies, CEO David Martin said.

“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,” Martin said in a statement. “Severe coronary arterial calcium is an underestimated problem in medicine, with limited options for treatment.”

In its pivotal trial, Diamondback 360 exceeded its two primary endpoints, charting a procedural success rate of 89.1% and leaving 89.8% of patients free of major adverse cardiac events.

The company has poured millions into the device’s development, and despite growing revenue 26% to $103.9 million last fiscal year, Cardiovascular Systems has yet to turn a profit. Now, with FDA approval in hand for an in-demand technology, Martin and his team have their work cut out for them.

Cardiovascular Systems said it’s planning a phased rollout of the device, targeting the country’s top medical centers over the next few quarters and in the meantime running postmarket studies to affirm Diamondback 360’s value in coronary atherectomy.

– read the announcement

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