The device continued to demonstrate long-term safety and effectiveness in treating coronary blockages and the treatment generated more than $4,000 per patient in cost-savings thanks to shorter hospital stays and a lower rate of readmissions, researchers said.
The 443-patient study was the 1st of its kind to examine orbital atherectomy, a relatively new atherectomy procedure, in patients with severe blockages in the coronary arteries. The study closed enrollment in November 2012.
"Patients with severe coronary calcium are more likely to experience major adverse events, or even death, and treatment of severely calcified coronary arteries remains a challenge," Metropolitan Heart & Vascular Institute’s Dr. Jeffrey Chambers said on behalf of the company. "However, one-year results from the ORBIT II study reaffirm what we learned from the 30-day data: CSI’s orbital atherectomy technology is a practical treatment that continues to demonstrate durable outcomes. Physicians have a new option to treat severe coronary calcium."
Researchers reported a 16.4% rate of major adverse cardiovascular events at 1 year, including a 9.7% rate of heart attack, 5.9% rate of target vessel/lesion revascularization and 3% rate of cardiac death. The results were presented during this month’s Cardiovascular Research Technologies in Washington, D.C.
The Diamondback 360 device has been on the U.S. market since landing FDA premarket approval in October 2013. The company has been on a roll since then, raising nearly $85 million through an underwritten public offering and releasing Q2 earnings that beat expectations.
The company has a big market to tap, with an estimated 16.3 million patients in the U.S. diagnosed with coronary artery disease, according to a CSI statement. In its most recent outlook, CSI said that it expects sales growth of 25%-30% for its fiscal 3rd quarter, projecting losses of -$9.2 million to -$10.1 million, or -31¢ to -34¢ per share, on sales of $33.0 million to $34.5 million.
CSII shares dropped 3.5% today, trading at $35 as of about 1:50 p.m. The stock has gained 1.7% since the start of the year.