Cardiovascular Systems ($CSII) can now add a PMA submission to its aggressively confident 2013. The Minnesota company said it completed a premarket approval application with the FDA for a new device designed to treat calcified coronary arteries.
The company handled its PMA application in three modules, divided between preclinical data, manufacturing/quality systems planning and clinical data. It's a process that started in late 2012--talk about meticulous.
Its ORBIT II clinical study will help shape the FDA's evaluation of Cardiovascular Systems' orbital atherectomy tech. ORBIT II, completed last November, involved 443 patients at 49 medical centers across the U.S. That trial did well for the company, it notes, meeting both primary safety and efficacy endpoints by a wide margin. Data from the test demonstrated close to a 90% rate of no major cardiac problems 30 days after the procedure, and an 89% success rate for the procedure itself.
The study is also the first IDE study to focus on patients with calcified coronary arteries. And the company sees a $1.5 billion underserved market. Surgeons find moderate to severely calcified arteries in up to 40% of patients who have some sort of percutaneous coronary surgery for coronary artery disease, Cardiovascular Systems notes, which can increase the risk of death or other problems.
Cardiovascular Systems booked $25.3 million in revenue during its fiscal 2013 second quarter ending Dec. 31, 2012, up 28% over the same period last year. Losses also grew, but the company has been spending more to support its ORBIT II trial and boost sales and marketing capacity in anticipation of launching its orbital atherectomy tech, and higher sales for its Stealth 360 PAD system.
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