ST. PAUL, Minn. & SAN DIEGO--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), featured two-year data from its ORBIT II study of the company’s Diamondback 360® Coronary Orbital Atherectomy System (OAS), the only U.S. Food and Drug Administration (FDA) approved Atherectomy Technology indicated for the treatment of severely calcified lesions, in a late-breaking presentation at the 2015 Society for Cardiovascular Angiography and Interventions (SCAI) conference in San Diego.
CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. The pivotal study evaluated the safety and efficacy of the company’s orbital atherectomy technology in treating patients with de novo severely calcified coronary lesions. ORBIT II was the first IDE study in history to evaluate this problematic subset of patients. In October 2013, CSI received PMA approval from the FDA to market its Diamondback 360 Coronary OAS as a treatment for severely calcified coronary arteries to facilitate stent delivery.
Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, highlighted new data that demonstrated a high freedom from major adverse cardiac events (MACE) rate, including target lesion revascularization (TLR) and target vessel revascularization (TVR), at two years for this difficult-to-treat patient population.
“ORBIT II two-year data further demonstrates the safety and efficacy of using CSI’s Diamondback 360 orbital atherectomy system to treat severely calcified coronary arteries,” said Dr. Chambers. “We have witnessed impressive clinical and economic benefits of using this device in a complex patient population that can be challenging to treat with traditional options. We also know now that using the coronary OAS device prior to stent treatment in severely calcified arteries yields durable, long-term results.”
Dr. Chambers presented the following two-year data:
|Two-Year Freedom From:|
|MI (CK-MB >3x ULN)*||90.3%|
*Based on reported CK-MB > 3X ULN
Long-Term Cost Effectiveness
Long-term patient outcomes are critical to understanding rates of hospital readmission when evaluating cost savings for the treating institutions and overall healthcare system. The Diamondback 360 Coronary OAS has been associated with a shorter length of stay for patients when the device was used to treat severely calcified lesions to facilitate stent placement compared to treating without the Diamondback 360. The lower incidence of readmission and shorter length of stay provide an estimated cost savings of up to $4,913 per patient to the treating institution at one year following the procedure.
The OAS device offers value with an incremental cost effectiveness ratio (ICER) of $11,895 per life year gained, which is well under the $50,000 per quality-adjusted life year (QALY) threshold, to be considered “high value.”
Said David L. Martin, CSI president and chief executive officer, “Coronary arterial calcium is traditionally difficult to treat, but the innovative technology of the Diamondback 360 device provides a safe and cost-effective way to remove calcium build up in even the most challenging cases. Our two-year results demonstrate remarkably improved clinical outcomes and one-year economic data demonstrated decreased treatment costs when our orbital atherectomy technology was employed as the primary treatment prior to stent deployment.”
About Coronary Artery Disease
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 percutaneous coronary intervention (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 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. To date, nearly 200,000 of CSI’s devices have been sold to leading institutions across the United States. For more information, visit the company’s website at www.csi360.com.
Indication: 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