Cardiovascular Systems Inc. (NSDQ:CSII) is starting a limited-market release of its Stealth 360 Orbital PAD System, the latest in its line of catheter-based systems that rub away plaque in clogged arteries in the pelvis or leg.
St. Paul, Minn.-based CSI 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 release of the Stealth 360 comes after the FDA granted 510(k) 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.
Cardiovascular Systems doesn’t expect any significant revenue from the Stealth 360 until its fourth quarter, which ends June 30.
President and CEO David Martin praised the Stealth 360’s electronic handle in CSI’s second-quarter earnings release
“Elimination of the controller, the capital equipment portion of our current system, will reduce future product cost,” Martin said.
For the first half of the fiscal year, Cardiovascular Systems brought in $36.9 million in revenue, a 22 percent increase from the first six months of the previous 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.