Cardiovascular Systems (NSDQ:CSII) is flying high today after announcing FDA approval for its Diamondback 360 atherectomy device for clearing calcium deposits from blood vessels. The company plans to launch commercial efforts right away.
The FDA win marks the 1st coronary atherectomy system approved in years, giving Cardiovascular Systems access to a market estimated at more than $1.5 billion per year, according to the company. CSII shares jumped 18.2%, trading at $26.86 as of about 2 p.m. today.
"Today is a landmark moment for: patients suffering from calcified coronary artery disease, their families, our physician operators and everyone at CSI," president & CEO David Martin said in prepared remarks. "FDA approval of our Diamondback 360 Coronary OAS allows us to bring to market the 1st new coronary atherectomy system in more than 2 decades."
Approval was supported by data from the company’s ORBIT II clinical trial, the 1st study of all time to focus on "the problematic subset of patients with severely calcified coronary lesions," according to a press release. Study results exceeded both safety and efficacy goals by a wide margin, with a procedural success rate of about 89% and about 90% freedom from major adverse cardiac events at 30 days.
The Diamondback device was approved for use in clearing coronary arteries, a significant milestone that the company hopes to use as a launching pad to breaching the larger vascular interventions market.
Cardiovascular Systems has been on a roll, with shares up more than 112% since the start of this year. Wall Street rewarded the device maker just last month, with CSII stock up 10% in the days following the company’s 4th-quarter earnings report.
Cardiovascular Systems reported losses of $6.8 million, or 28¢ per share, on sales of $28.8 million during the 3 months ended June 30, 2013. Analysts had predicted losses of about 39¢ per share for the quarter. The Q4 2013 results compare with losses of $4.6 million, or 24¢ per share, on sales of $22.9 million during the same period last year.