Cardiovascular Systems Enrolls First Subject in ECLIPSE Coronary Clinical Trial

Cardiovascular Systems Inc. (CSI), in partnership with Cardiovascular Research Foundation (CRF), announces the first subject enrolled in its ECLIPSE clinical trial. The patient was treated by Dr. Richard Shlofmitz, interventional cardiologist and director of the Department of Cardiology at St. Francis Hospital in Roslyn, N.Y. Shlofmitz also treated patients in CSI’s ORBIT II and COAST clinical studies.
 
“Severely calcified coronary lesions have continued to grow in complexity while treating coronary artery disease (CAD),” Shlofmitz said. “The Diamondback 360 Coronary Orbital Atherectomy System (OAS) provides a novel treatment option for these patients compared to conventional angioplasty. Definitive data from the ECLIPSE clinical trial will guide my treatment approach for these difficult-to-treat patients.”
 
ECLIPSE is a prospective, multi-center, randomized clinical trial of approximately 2,000 subjects with severely calcified coronary lesions in the United States. Half the participants will receive orbital atherectomy prior to drug-eluting stent (DES) implantation, while the other half will receive conventional angioplasty, including specialty balloons, followed by DES implantation. The trial is powered to demonstrate differences in the primary endpoints of post-procedural minimal cross-sectional area (assessed by intravascular imaging in a subset of up to 400 patients) as well as in the clinical outcome of target vessel failure at one year. ECLIPSE will also evaluate key health economic outcomes.
 
“Many of us feel that coronary atherectomy is underutilized, particularly given the increasing complexity of lesions and patients seen in current-day interventional practice,” said Dr. Ajay Kirtane, director of the Cardiac Catheterization Laboratories at New York-Presbyterian/Columbia University Irving Medical Center, and one of the principal investigators of the ECLIPSE trial. Approximately 12 percent of coronary lesions are calcified, and current estimates suggest that atherectomy is only used in approximately 3 percent of coronary interventions. Kirtane added, “ECLIPSE is the largest randomized clinical trial to date expressly designed to assess the utility of adjunctive coronary atherectomy for calcific CAD.”
 
“Coronary calcification has been shown to increase procedural difficulty and adverse events following conventional percutaneous coronary intervention (PCI). The use of orbital atherectomy has the ability to significantly modify lesion morphology, enabling successful stent delivery to help optimize stent expansion and apposition,” said Dr. Philippe Généreux, co-principal investigator of the trial, interventional cardiologist at Morristown Medical Center, (New Jersey), and director of the Angiographic Core Laboratory at the CRF Clinical Trials Center. “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 CAD.”
 
“Our commitment to clinical rigor continues to be a cornerstone in advancing our leadership in atherectomy,” said Scott Ward, president and CEO of Cardiovascular Systems. “The ECLIPSE trial is another important scientific step in demonstrating that the Diamondback 360 Coronary OAS will broaden physicians’ ability to safely and effectively treat more challenging CAD patients.”
 
CSI’s Diamondback 360 Coronary OAS is the first and only atherectomy device approved to specifically treat severely calcified coronary arteries. Since U.S. Food and Drug Administration (FDA) approval in October 2013, more than 25,000 devices have been used to treat patients with CAD.
 
CAD is a life-threatening condition and a leading cause of death in American adults. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a PCI. Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).
 
Cardiovascular Systems, based in St. Paul, Minn., develops and commercializes solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The FDA granted the first 510(k) clearance for the use of the Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the Coronary Orbital Atherectomy System. To date, more than 290,000 of CSI’s devices have been sold to U.S. institutions.