Cardiovascular Systems recently announced the first patient had enrolled in the company’s ECLIPSE trial, which is evaluating its Diamondback 360 coronary orbital atherectomy system.
Richard Shlofmitz, MD, an interventional cardiologist and the director of the department of cardiology at St. Francis Hospital in Roslyn, New York, treated the first patient.
Since the FDA approved the Diamondback 360 in October 2013, physicians have used more than 25,000 devices to treat patients with coronary artery disease, according to Cardiovascular Systems. The company added that it has sold more than 290,000 devices in the U.S.
During the ECLIPSE trial, the researchers plan on enrolling approximately 2,000 patients with severely calcified coronary lesions. The patients will be randomized in a 1:1 ratio to receive orbital atherectomy before drug-eluting stent implantation or conventional angioplasty following drug-eluting stent implantation.
The study’s primary endpoints are post-procedural minimal cross-sectional area and target vessel failure at one year. Cardiovascular Systems also plans on evaluating health economic outcomes.
Approximately 12 percent of coronary lesions are calcified, according to a company news release. In addition, atherectomy is used in approximately 3 percent of coronary interventions.
“Coronary calcification has been shown to increase procedural difficulty and adverse events following conventional percutaneous coronary intervention (PCI),” Dr. Philippe Généreux, MD, co-principal investigator of the trial, said in a news release. “The use of orbital atherectomy has the ability to significantly modify lesion morphology, enabling successful stent delivery to help optimize stent expansion and apposition. This supports why we are randomizing to conventional angioplasty, toward the goal of ultimately improving PCI outcomes. The value of this trial is that it will inform physicians regarding the most effective treatment protocols and strategies for treating patients with calcific [coronary artery disease].”
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.