Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) today announced new medical diagnosis and procedure codes for severely calcified coronary arteries. These codes will allow providers to track the costs of treating high-risk patients with severely calcified coronary lesions, which is the first step toward establishing specific reimbursement rates for this unique patient population. Severely calcified coronary lesions are often underestimated, even though they present unique challenges that existing treatment options cannot overcome. These lesions are more difficult to access, resulting in higher procedural complications and suboptimal stent placement. Calcified lesions are also associated with an increased risk of retreatment, heart attacks and even death.

“High-risk coronary patients often require additional resources during treatment. In the past, these and other patients were combined under a single code, which prohibited providers from tracking costs associated with treating patients with more severe disease,” said David L. Martin, CSI president and chief executive officer. “Our goal is to understand and serve this high-risk group, improve outcomes and align reimbursement rates.”

Dr. Jeffrey Chambers, Metropolitan Heart and Vascular Institute, Minneapolis added, “Of the 1.7 million patients treated annually via less invasive and surgical interventions for coronary artery disease, about 10 percent to 20 percent are afflicted with severely calcified arteries. Physicians and hospitals have long known it is more difficult and time consuming to treat patients with severely calcified coronary arteries. These patients also have significantly higher major adverse coronary events when treated with currently available technology. With the use of these new codes, we will have the ability to quantify the additional resources needed to optimality treat these patients.” Dr. Chambers is the principal investigator for ORBIT II, CSI’s pivotal trial for a coronary application.

The ICD-9-CM Coordination Committee of the Department of Health and Human Services activated these new and revised codes:

Procedural Codes
  • Revised: Code 00.66, percutaneous transluminal coronary angioplasty (PTCA)
  • New: Code 17.55, transluminal coronary atherectomy, directional atherectomy, excimer laser atherectomy, rotational atherectomy, that by laser, that by percutaneous approach, that by transluminal extraction

Diagnosis Code
  • New: Code 414.4, coronary atherosclerosis due to calcified coronary lesion; coronary atherosclerosis due to severely calcified coronary lesion, code first coronary atherosclerosis (414.00-414.07)

Inpatient Hospital Procedure Code
  • Revised: Code 00.66 was modified to describe PTCA only instead of PTCA or coronary atherectomy

The new and revised codes are used for submissions related to inpatient hospital procedures on the hospital UB-04 claim form. For more information, visit www.csi360.com.

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 Stealth 360° TM, Diamondback 360 ® and Predator 360 ® PAD 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 360° in August 2007, the Predator 360° in March 2009 and for the Stealth 360° in March 2011. To date, more than 55,000 PAD procedures have been performed using CSI's PAD systems in leading institutions across the United States.

CSI has also commenced its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. 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.

Safe HarborCertain 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, the statement in this press release regarding CSI’s goal to align reimbursement rates with the cost of treating severely calcified coronary lesions is a forward-looking statement. These statements involve risks and uncertainties which could cause results to differ materially from those projected, including but not limited to the establishment of specific reimbursement rates for patients with severely calcified coronary lesions, the activities of physicians in treating these patients, 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.

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