Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), released two-year data from its ORBIT II study of the company’s Diamondback 360® Coronary Orbital Atherectomy System (OAS) in treating severely calcified lesions in a late-breaking presentation at the at the 2015 Cardiovascular Research Technologies (CRT) conference in Washington, D.C.
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 U.S. Food and Drug Administration (FDA) to market its Diamondback 360 Coronary OAS as a treatment for severely calcified coronary arteries.
Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, Minn. highlighted new data that demonstrated low major adverse cardiac events (MACE) rates, 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 reaffirms that CSI’s orbital atherectomy technology is a safe and effective treatment option for severely calcified arteries,” said Dr. Chambers. “Results continue to show the clinical and economic benefits of this device. Furthermore, we now know that using the coronary OAS device prior to stent placement in severely calcified arteries has shown positive long-term results in a complex and problematic patient population.”
Dr. Chambers presented the following two-year data:
MACE (Two Year)* | 19.4% | |||
MI (CK-MB >3x ULN)* | 9.7% | |||
Non Q-wave | 8.8% | |||
Q-wave | 0.9% | |||
Target Vessel/Lesion Revascularization | 8.1% | |||
TVR | 2.9% | |||
TLR | 6.2% | |||
Cardiac Death | 4.3% |
*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
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 $3,100 per patient to the
treating institution.
“The two-year results of the ORBIT II study continue to demonstrate positive results following treatment with the Diamondback 360 device in treating severely calcified arteries and CSI’s commitment to delivering innovative, durable and cost-effective solutions,” said David L. Martin, CSI president and Chief Executive Officer. “Coronary arterial calcium often results in poor clinical outcomes and higher treatment costs, but our two-year results demonstrate significant improvements in both of these areas when our orbital atherectomy technology is employed.”
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 182,000 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.
Product Disclosure
Coronary Product
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
Contacts:
Jack Nielsen, 651-202-4919
j.nielsen@csi360.com
or
PadillaCRT
Matt
Sullivan, 612-455-1709
matt.sullivan@padillacrt.com