UPDATED Nov. 27, 2012, with comment from Leerink Swann analyst Danielle Antalffy, closing share price.
The catheter-delivered device uses a diamond-coated crown to remove occlusive material from constricted blood vessels. The Orbit II trial, which the St. Paul, Minn.-based medical device company hopes will back its pre-market approval application with the FDA for treating severely calcified coronary arteries, involved treatment with an earlier, pneumatically powered device and a newer electric model, according to a press release.
Another version of the Diamondback 360 device is already approved for treating peripheral artery disease.
"Completing Orbit II enrollment is a significant milestone in our efforts to secure a coronary indication to treat arterial calcium – a vastly underestimated problem in medicine today," president & CEO David Martin said in prepared remarks.
Patients with calcified coronary arteries showed statistically higher rates of death and major adverse cardiac events in a study of 11,651 patients treated with drug-eluting stents, according to a press release.
Cardiovascular Systems said it’s already submitted the 1st modules for its PMA application, a pre-clinical module and manufacturing/system quality module. The 3rd and final module will include the Orbit II safety and effectiveness data along with proposed labeling.
Leerink Swann analyst Danielle Antalffy told MassDevice.com that the news is in line with CSII’s forecast for approval from the federal watchdog agency by late 2013 or early 2014. Winning the coronary indication would give CSII access to a market potentially worth $1.5 billion, Antalffy told us.
"I think you have to view this coronary indication as upside," she said. "If it gets approved, the question is going to be, ‘How often does it get used?’ We view it as potential upside, but what’s the real market opportunity here? It could be meaningful, but it’s too early to tell."
But even without the coronary indication, Antalffy noted, Cardiovascular Systems would be a natural tuck-in acquisition for a large-cap device maker looking for adjacencies to its cardiology lines.
"These large-cap companies are going to be in a position in which the easiest way to grow is to acquire. The [CSII] technology is very complementary, and the touchpoint is the same – the interventional cardiologist. It’s literally just adding a device into a salesperson’s bag. It would be highly accretive as well. It makes a lot of sense both from a strategic standpoint and from a financial perspective."
CSII shares closed at $11.69 apiece today, up 1.0%.