Cardiovascular Systems Completes PMA Submission of Orbital Atherectomy
System for Coronary Artery Disease Treatment
Modular Application Includes ORBIT II Data that Surpassed the Trial’s Primary
ST. PAUL, Minn. -- March 15, 2013
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), announced today that it has
submitted its Premarket Approval (PMA) application to the U.S. Food and Drug
Administration (FDA) for its orbital atherectomy system, used to treat
calcified coronary arteries.
The completed PMA application marks another major coronary milestone for CSI,
following the release of ORBIT II pivotal trial results at the recent 2013
American College of Cardiology (ACC) conference. CSI’s technology produced
clinical outcomes that exceeded the trial’s two primary safety and efficacy
endpoints by a significant margin—within one of the most challenging patient
“Coronary arterial calcium is a vastly underestimated problem in medicine
today, and there is a pressing need for a solution,” said David L. Martin,
president and CEO of Cardiovascular Systems. “The ORBIT II results we shared
at ACC show that our orbital atherectomy technology may be a viable treatment
option for calcified coronary arteries. We look forward to working with the
FDA on a potential coronary indication for this most challenging, underserved
The company completed ORBIT II enrollment of 443 patients at 49 U.S. medical
centers in November 2012. ORBIT II is evaluating the safety and effectiveness
of the company’s orbital atherectomy technology in treating patients with
severely calcified coronary lesions. This is the first Investigational Device
Exemption study in history to evaluate this problematic subset of patients. At
ACC, Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute,
Minneapolis, presented data that showed a 30-day freedom from MACE (major
adverse cardiac events) rate of 89.8 percent and procedural success of 89.1
percent (including in-hospital MACE).
According to estimates, moderate to severe arterial calcium is present in
nearly 40 percent of patients undergoing a percutaneous coronary intervention.
Moderate-to-severe 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 MACE. Coronary approval would
open up a large, underserved market opportunity for CSI, estimated to exceed
$1.5 billion annually in the United States.
The FDA agreed to a modular PMA process that allowed CSI to submit the first
two modules covering preclinical data and manufacturing/quality systems, while
still collecting, compiling and analyzing the clinical data. CSI has now
submitted the third and final PMA application module, as well as responses to
FDA comments on the first two modules, which were submitted in late 2012.
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 several of the following: high blood pressure, abnormal cholesterol
levels, diabetes, or family history of early heart disease. CAD affects an
estimated 16.8 million people in the United States and is 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.
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 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 100,000
of CSI’s devices have been sold to leading institutions across the United
States. The coronary system is limited by federal law to investigational use
and is currently not commercially available in the United States.
For more information, visit the company’s website at www.csi360.com.
Cardiovascular Systems, Inc.
Investor Relations, 651-259-2800
Sarah Wozniak, 651-259-1636
Padilla Speer Beardsley Inc.
Matt Sullivan, 612-455-1709
Dave Folkens, 612-455-1741
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