Cardiovascular Systems Enrolls First Patients In OPTIMIZE Study

ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), announced that the first two patients have been enrolled in its OPTIMIZE, peripheral Orbital Atherectomy System (OAS) study. Taking place in Europe, OPTIMIZE will evaluate the acute and long-term clinical outcomes of orbital atherectomy with adjunctive drug-coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD). Specifically, the study will look at patients with calcified below the knee (BTK) lesions. OPTIMIZE also will compare the economic outcomes between the patient groups. Professor Marianne Brodmann, MD, Director of the Division of Angiology, Medical University of Graz, Austria, performed the first procedure on October 28 together with Hannes Deutschmann, Director of the Vascular and Interventional Department of Radiology, Medical University of Graz, Austria and Dr. Franz Hafner.

“Studying the combination of orbital atherectomy and drug-coated balloon angioplasty is an important step in our commitment to minimizing the adverse consequences of PAD for the millions of people afflicted with the disease”

“We are excited to spearhead the study of CSI’s orbital atherectomy technology in Europe,” said Dr. Brodmann. “Below the knee PAD is associated with a higher prevalence of calcium than above the knee PAD. We look forward to evaluating the potential outcome benefit of using CSI’s orbital atherectomy system to remove calcified plaque prior to DCB angioplasty in this high-risk patient population.”

OPTIMIZE is a prospective, randomized, multi-center, post-market pilot study using CSI’s peripheral OAS to perform atherectomy procedures in conjunction with drug coated balloons. Up to 50 subjects may be enrolled at up to 10 study sites throughout the continent.

Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the peripheral OAS, minimally invasive catheter systems developed and manufactured by CSI. The orbital atherectomy 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 may lead to vessel damage and suboptimal results.

“Studying the combination of orbital atherectomy and drug-coated balloon angioplasty is an important step in our commitment to minimizing the adverse consequences of PAD for the millions of people afflicted with the disease,” said David L. Martin, CSI president and chief executive officer. “Our goal is to show that for calcified BTK arteries, pre-treatment with orbital atherectomy followed with DCB, will provide incremental benefits versus DCB angioplasty alone.”

The national principal investigators for OPTIMIZE are Dr. Brodmann; Professor Gunnar Tepe, MD, Klinikum Rosenheim, Germany; and Professor Thomas Zeller, MD, Herz-Zentrum Bad Krozingen, Germany.

About Peripheral Arterial Disease (PAD)
As many as 18 million Americans, most over age 65, suffer from PAD, which is caused by plaque accumulation 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 continues to grow.

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. The Stealth 360® Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. To date, over 220,000 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.

Safe Harbor
Certain 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, statements in this press release regarding the OPTIMIZE trial, including the number of subjects expected to be enrolled and the number of sites and the expected outcomes of the trial,, are forward-looking statements. These statements involve risks and uncertainties which could cause results to differ materially from those projected, including but not limited to the effectiveness of the peripheral OAS; actual clinical trial and study results; government clearances and approvals; 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.

Peripheral Product Disclosures
The Stealth 360® PAD System and Diamondback 360® PAD System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.