St. Mary Medical Center Enrolls First Patient in Pennsylvania in National Coronary Clinical Device Trial - Archived
Study investigates effectiveness of ORBIT II Device to treat calcified coronary arteries
LANGHORNE, Pa., September 13, 2011 – St. Mary Medical Center is the first hospital in the tri-state area to treat a patient as part of a national clinical trial of a device that sands away calcified coronary artery plaque. Known as the ORBIT II Trial, it is an Investigational Device Exemption (IDE) clinical trial to evaluate the safety and effectiveness of the Diamondback 360® Coronary System (Cardiovascular Systems, Inc., St. Paul, Minn.) in treating calcified coronary arteries.
“Severely calcified coronary lesions have frequently been excluded from other clinical studies over the past decade because they are a clinical challenge for coronary interventions,” says Rakesh Shah, MD, who treated the first patient. “This study is one of the first steps in helping us determine if this device will be another treatment option we can offer patients with coronary artery disease.”
Coronary artery disease (CAD) is the most common form of heart disease in the U.S., affecting more than 16 million people. Patients with severely calcified CAD may benefit from treatment with the Diamondback 360°, which sands away the calcified (or hardened) plaque blocking the artery. Removing the hardened plaque may make it safer and easier for the physician to place a stent and thus restore blood flow to the heart. In some patients, this treatment may take the place of heart bypass surgery, an open-heart procedure.
The ORBIT II Trial IDE clinical trial will evaluate the safety and effectiveness of the Diamondback 360° Coronary System. Up to 429 patients will be enrolled in the study, which advances CSI’s progress toward US regulatory approval for a coronary application of the device. Patients that qualify for the study will have severely calcified coronary blockages that have not previously been treated.
The coronary system was previously tested in coronary arteries in the ORBIT I first-in-human feasibility study of 50 patients in India. ORBIT I took place in 2008 and showed that the Diamondback 360° was successful in 98 percent of patients with calcified coronary lesions, with an acute procedural success rate of 94 percent. These results demonstrating safety and efficacy of the device were among the data the FDA considered in granting approval to proceed with the ORBIT II IDE study.
In addition to using the in the device in the ORBIT II clinical trial, Rakesh Shah, MD has extensive experience in treating patients using the Diamondback 360° System for peripheral arterial disease (PAD). More than 35,000 patients nationwide have been treated with the peripheral version of the System since it was released to market in the fall of 2007.
For more information about the ORBIT II clinical trial, contact Marci Campbell, RN, BSN, CCRP at 215-710-4586.