Cardiovascular Systems Unveils New Data from CONFIRM Study Series at the New Cardiovascular Horizons

Cardiovascular Systems Unveils New Data from CONFIRM Study Series at the New Cardiovascular Horizons Conference

Subanalysis of CONFIRM Data Highlights Orbital Atherectomy's Safety in Treating PAD within Claudicant, CLI, and Renal Disease Patient Populations

• Plaque modification with orbital atherectomy resulted in similar low procedural complication rates for both patients with and without renal disease

• Both claudicants and critical limb ischemia patient groups had low rates of procedural events, regardless of arterial calcium burden

ST. PAUL, Minn.--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSI) (NAS: CSII) , unveiled new data from its CONFIRM study series in three poster presentations at the 2013 New Cardiovascular Horizons (NCVH) conference in New Orleans.

The CONFIRM study series evaluated the use of CSI's orbital atherectomy system as a treatment for peripheral arterial disease (PAD)—in above- and below-the-knee lesions—in a real world population of patients (with no exclusions).

Eighty-one percent of the lesions treated had severe or moderate calcification—historically considered a difficult patient population to treat. Patients studied included those suffering from renal disease, claudication (painful circulatory problems), and/or critical limb ischemia (CLI) (the worst form of PAD, caused by chronic inflammation in lower extremities).

CSI posters include:

Pooled Analysis of the CONFIRM Registries: Outcomes in Patients with Renal Disease Treated for Peripheral Arterial Disease with Orbital Atherectomy

Dr. Michael Lee, UCLA Medical Center, Los Angeles, shared data from "Pooled Analysis of the CONFIRM Registries: Outcomes in Patients with Renal Disease Treated for Peripheral Arterial Disease with Orbital Atherectomy." Results show that plaque modification with CSI's orbital atherectomy system resulted in similar low procedural complication rates for patients with renal disease, compared to those without, despite having more unfavorable baseline clinical and lesion characteristics.

"Calcified lesions are difficult to treat, and patients with renal disease could have increased complications after peripheral intervention. These hard-to-treat patients have historically been excluded from clinical trials," said Dr. Lee. "Treatment with CSI's orbital atherectomy system resulted in low procedural complication rates, whether patients suffered from renal disease or not—indicating that orbital atherectomy is an effective tool for treating PAD, despite the severity of lesion characteristics."

Orbital Atherectomy Outcomes of the Critical Limb Ischemia Patient Population within the CONFIRM Series

"Orbital Atherectomy Outcomes of the Critical Limb Ischemia Patient Population within the CONFIRM Series," by Dr. Tony Das, Cardiology and Interventional Vascular Associates, Dallas, Texas, was also shared at NCVH. Approximately 44 percent of patients in the CONFIRM series suffered from CLI, yet the occurrence of procedural complications was low after treatment with CSI's orbital atherectomy system, regardless of arterial calcium burden.

Orbital Atherectomy Outcomes of the Claudicant Patient Population within the CONFIRM Series

Dr. George Adams, Rex Health Care, Raleigh, N.C., shared data from "Orbital Atherectomy Outcomes of the Claudicant Patient Population within the CONFIRM Series." Claudicant patients represented 56 percent of patients in the CONFIRM study series, and of those patients, 81 percent had moderate to severely calcified lesions. Orbital atherectomy proved to be a safe tool for restoring blood flow in claudicant patients, regardless of the calcium severity.

"The majority of claudicant patients suffered from moderate-to-severe calcification, yet the occurrence of procedural complications was low after treatment with CSI's orbital atherectomy system," said Dr. Adams. "The favorable results demonstrate that orbital atherectomy can effectively treat PAD in claudicant patients, regardless of calcium burden."

About Peripheral Arterial Disease

As many as 8 million to 12 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing faster than the rest of the population.

Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Stealth 360° and Diamondback 360°, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue — a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.

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, nearly 110,000 of CSI's devices have been sold to leading institutions across the United States. CSI has also completed 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.

Cardiovascular Systems, Inc.
Investor Relations, 651-259-2800
investorrelations@csi360.com
or
Sarah Wozniak, 651-259-1636
swozniak@csi360.com
or
Padilla Speer Beardsley Inc.
Matt Sullivan, 612-455-1709
msullivan@padillaspeer.com
or
Dave Folkens, 612-455-1741
dfolkens@padillaspeer.com

KEYWORDS: United States North America Louisiana Minnesota

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