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FDA clears CSI to market newest device for treating clogged arteries

Cardiovascular Systems Inc. recently announced that it’s started a limited-market release of its Stealth 360° Orbital PAD System, the latest in the company’s line of catheter-based systems that rub away plaque in clogged arteries in the pelvis or leg. St. Paul, Minnesota-based CSI (NASDAQ:CSII) claims the Stealth 360° has a simpler, more user-friendly design than […]

Cardiovascular Systems Inc. recently announced that it’s started a limited-market release of its Stealth 360° Orbital PAD System, the latest in the company’s line of catheter-based systems that rub away plaque in clogged arteries in the pelvis or leg.

St. Paul, Minnesota-based CSI (NASDAQ:CSII) claims the Stealth 360° has a simpler, more user-friendly design than previous devices in the company’s Orbital PAD System family — the Diamondback 360 and Diamondback Predator 360°.

Click here to watch an animated video about how the Stealth 360° works.

“The new Stealth 360° is as fast and easy to set up as a balloon or stent, but safer and more durable,” Dr. J. Mustapha, an interventional cardiologist at Metro Health Hospital in Grand Rapids, Michigan, said in a Cardiovascular Systems news release.

The release of the Stealth 360° comes after U.S. Food and Drug Administration 510(k) marketing clearance. The limited market release is meant to provide a smooth transition to the new platform, with the company seeking feedback from physicians to establish best practices for device operation.

Cardiovascular Systems doesn’t expect any significant revenue from the Stealth 360° until the company’s fourth quarter, ending June 30.

In CSI’s second-quarter earnings release, David Martin,  the company’s president and CEO, praised the Stealth 360°’s electronic handle. “Elimination of the controller, the capital equipment portion of our current system, will reduce future product cost,” he said.

For the first half of its present fiscal year, Cardiovascular Systems brought in $36.9 million in revenue, a 22 percent increase from the first six months of the previous fiscal year. Losses for the six months ended Dec. 31 were $6.3 million, less than half what they were during the same period a year before.