ST. PAUL, Minn. & WASHINGTON--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), released one-year data from its ORBIT II study of the company’s Diamondback 360® Coronary Orbital Atherectomy System in treating severely calcified lesions at the 2014 Cardiovascular Research Technologies (CRT) conference in Washington, D.C. Results were presented as part of CRT’s iMPACT Trials, which are innovative reports that provide the latest breakthroughs in clinical science. The studies selected for the iMPACT Trials session at CRT highlight new improvements for quality of patient care, and significantly impact the field of interventional cardiology.
CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. The pivotal study evaluated the safety and effectiveness of the company’s orbital atherectomy technology in treating patients with severely calcified coronary lesions. ORBIT II is the first study in history to evaluate this problematic subset of patients. In October 2013, CSI received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360 Coronary Orbital Atherectomy System as a treatment for severely calcified coronary arteries.
Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, highlighted new data that demonstrates low MACE rates, including target lesion revascularization (TLR) and target vessel revascularization (TVR), at one year versus historical data for this difficult-to-treat patient population.
“Patients with severe coronary calcium are more likely to experience major adverse events, or even death, and treatment of severely calcified coronary arteries remains a challenge,” said Dr. Chambers. “However, one-year results from the ORBIT II study reaffirm what we learned from the 30-day data: CSI's orbital atherectomy technology is a practical treatment that continues to demonstrate durable outcomes. Physicians have a new option to treat severe coronary calcium.”
Dr. Chambers presented the following one-year data:
|
MACE (One Year) |
16.4% | |
| MI (CK-MB >3x ULN | 9.7% | |
| Non Q-wave | 8.8% | |
| Q-wave | 0.9% | |
| Target Vessel/Lesion Revascularization | 5.9% | |
| TVR | 1.9% | |
| TLR | 4.7% | |
| Cardiac Death | 3.0% |
Demonstrating Cost Effectiveness
The ORBIT II one-year data continues to demonstrate low target lesion revascularization (TLR) and target vessel revascularization (TVR) versus historical data for this difficult-to-treat patient population. 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 lower length of stay for patients when the device was used to treat severely calcified lesions compared to treating without the Diamondback 360. A lower incidence of readmission and lower length of stay provide an estimated cost savings in excess of $4,000 per patient to the treating institution.
“The ORBIT II results demonstrate CSI's commitment to delivering innovative and cost-effective solutions to treat calcified arterial disease,” said David L. Martin, CSI president and Chief Executive Officer. “Coronary arterial calcium is a significantly underserved and problematic condition, often resulting in poor outcomes and higher treatment costs. The results shared at CRT show that our orbital atherectomy technology provides cost-effective and long-term durable outcomes for these difficult-to-treat patients.”
About Coronary Artery Disease
Coronary Artery Disease (CAD) is a life-threatening condition and 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, or 1 in 4 Americans, 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 August 2007. To date, over 135,000 of CSI’s devices have been sold to leading institutions across the United States. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. For more information, visit the company’s website at www.csi360.com.
Product Disclosure
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 percent has not been evaluated.
See the instructions for use before performing Diamondback 360 coronary orbital atherectomy 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.
