Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII), has received Food and
Drug Administration (FDA) conditional Investigational Device Exemption
(IDE) approval to evaluate the safety and effectiveness of its
Diamondback 360® System in the treatment of calcified
coronary lesions. With this conditional approval, CSI is authorized to
begin its pivotal trial, ORBIT II, in early 2010 and initially enroll up
to 100 patients at as many as 50 U.S. sites. Dr. Jeffrey Chambers, an
interventional cardiologist with Metropolitan Cardiovascular
Consultants, Minneapolis, is the principal investigator for ORBIT II.
The Diamondback 360° is a minimally invasive catheter, which received
FDA 510(k) marketing clearance in 2007 for the treatment of peripheral
arterial disease.
“We have seen the advantages of using the Diamondback 360° in removing
calcified coronary plaque prior to using stents or angioplasty”
“The U.S. market for coronary interventions is currently estimated at
more than $4 billion, representing 1.3 million procedures each year,”
said David L. Martin, president and CEO of Cardiovascular Systems. “A
complementary tool to stents and angioplasty, we expect our Diamondback
360° to play a significant role in this market by removing the calcified
or fibrocalcific disease to increase the effectiveness of the other
therapies. We are optimistic that the success of the Diamondback 360° in
treating peripheral arterial disease — as confirmed in our landmark
OASIS study and in more than 20,000 patients to date — can be repeated
in the treatment of coronary disease.”
In 2008, CSI completed the first in-human ORBIT I coronary trial, a
feasibility study which enrolled 50 patients in India. The Diamondback
360° was shown successful in 98 percent of patients, and the acute
procedural success rate was 94 percent. These results met the company’s
safety and efficacy endpoints and were among the data the FDA considered
in granting conditional IDE approval.