ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), in partnership with Cardiovascular Research Foundation (CRF), announces the first subject enrolled in its ECLIPSE clinical trial. The subject was treated by Dr. Richard Shlofmitz, interventional cardiologist and the Director of the Department of Cardiology at St. Francis Hospital, Roslyn, NY. Dr. Shlofmitz also treated subjects 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)," Dr. 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 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, the 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. Dr. Kirtane added, “ECLIPSE is the largest randomized clinical trial to date expressly designed to assess the utility of adjunctive coronary atherectomy for calcific CAD.”
Said Dr. Philippe Généreux, co-principal investigator of the trial, interventional cardiologist at Morristown Medical Center, NJ, and the Director of the Angiographic Core Laboratory at the CRF Clinical Trials Center, “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. 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 FDA approval on October 21, 2013, over 25,000 devices have been used to treat patients with CAD.
Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding the ECLIPSE clinical trial are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, the potential for unanticipated delays in enrolling medical centers and patients for the ECLIPSE clinical trial, actual clinical trial results, and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.
About Coronary Artery Disease (CAD)
CAD is a life-threatening condition and a leading cause of death in men and women in the United States. 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).
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative 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 U.S. 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, over 290,000 of CSI’s devices have been sold to leading institutions across the United States.
Indications: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Contraindications: The OAS is contraindicated when the ViperWire guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated. See the instructions for use before performing Diamondback 360 Coronary OAS procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
For more information, visit the company’s website at www.csi360.com.