CARDIOVASCULAR SYSTEMS’ DATA FOR TREATMENT OF PERIPHERAL ARTERIAL DISEASE IN OFFICE-BASED LAB SETTINGS PRESENTED AT SOCIETY FOR INTERVENTIONAL RADIOLOGY MEETING

Results show the acute safety and efficacy of the Diamondback^TM Orbital Atherectomy System in a non-hospital setting:

§  Patient acute safety and clinical outcomes equal to hospital setting

§  No cases of flow limiting dissections or perforations

§  Procedure treatment run times, number of devices per lesions and other parameters are consistent with hospital-based procedures

St. Paul, Minn. – March 29, 2012 – Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), today announced results from a study of patients treated for peripheral arterial disease (PAD) with CSI’s Diamondback™ Orbital Atherectomy System in a non-hospital setting. 

In this prospective, single-center study, 100 consecutive procedures were performed on 84 patients (157 vessels) over a nine-month period by Dr.William Julien, chief executive officer of South Florida Vascular Associates. Of these patients, 64.9 percent had claudication and 35.1 percent had critical limbischemia. The mean atherectomy run time was only 55 seconds. Low-pressure adjunctive angioplasty was performed in all cases. The average pre-procedure vessel stenosis was 78 percent; after treatment, mean vessel stenosis was 11 percent. The dissection rate was only 2.8 percent, none of which were flow limiting, and no perforations were reported. All patients were discharged to their homes, with no hospital transfers. There were no cases of hospital admission or major adverse events within 24 hours.    

“With today’s growing economic pressures, office-based endovascular suites are becoming more common as physicians look for opportunities to assert more control over the patient care process and enhance practice productivity,” said Dr. Julien. “These data show that CSI’s Diamondback Orbital Atherectomy System can be safely used for treating calcified lesions in the OBL setting, with the positive patient outcomes consistent with those seen in the hospital environment.”

David L. Martin, CSI president and chief executive officer, added: “This study demonstrates that patients with moderate to severe calcium can receive excellent clinical outcomes in hospital and non-hospital settings. We are excited to show that patients, physicians and payors can benefit from CSI’s clinically proven product – in both settings.”

About Peripheral Arterial Disease

As many as 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 at double-digit rates.

Millions of patients with PAD may benefit from treatment with the Diamondback Orbital Atherectomy System, a minimally invasive catheter system developed and manufactured by CSI. This system uses a diamond-coated crown, attached to a guide wire, which sands away plaque while preserving healthy vessel tissue, or medial integrity — 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 Diamondback Orbital Atherectomy System treats calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and addresses 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, more than 61,000 PAD procedures have been performed using CSI’s technology 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.

Product Disclosure

The Diamondback Orbital Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The system is 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.

Ground-Breaking South Florida Interventional Radiologist Achieves Excellent Patient Outcomes With Continuum of Care Model of Delivery

William Julien, MD, is a Leading Expert in the Development of Office-Based Clinical Endovascular Practices

Coconut Creek, Fl- South Florida Vascular Associates Medical Director William Julien, M.D., is one of only a few interventional radiologists in the nation to have an office-based clinical practice where he provides pre- to post-operative care to his patients suffering from vascular diseases. His practice is unique because, unlike most interventional radiologists, Dr. Julien sees his own patients and treats 95% of them in his office in a sophisticated endovascular suite, one of the first of its kind in the country. Recently, Dr. Julien opened an 8,000-sq.-ft. facility equipped with three state-of-the-art operating suites coupled with a team of the region's most highly skilled medical staff, offering patients a unique and convenient continuum of care compared to a traditional hospital setting where traditional interventional radiologists typically see and treat their patients.

South Florida Vascular Associates' medical staff treats a variety of vascular conditions, including peripheral artery disease, abdominal aortic aneurysm, varicose veins, deep vein thrombosis and carotid artery disease.

Each year the practice's physicians perform more than 1,000 image-guided endovascular procedures in their office-based setting utilizing the latest cutting-edge technology, which is implemented by specialty-trained vascular medical professionals. Office-based procedures are easier on the patient because the patients are in a relaxed environment, there is little to no wait time for surgery, the procedures are performed under IV sedation as opposed to general anesthesia, and there is a comfortable waiting area for the families. In-office endovascular procedures are also less expensive than hospital procedures for insurance carriers.

"Our endovascular practice focuses on the continuity of patient care from our first meeting until the patient is fully recovered," said Dr. Julien. "I have the opportunity to know each of my patients personally and patient outcomes are excellent with this advanced model of delivering vascular care. We emphasize the importance of patient education, offering patients clear explanations of their diagnosis and treatment plan, including providing the most comprehensive endovascular services in a fully-equipped, private, comfortable setting."

Unlike vascular surgery, which treats vascular disease with open surgery, endovascular surgery is a branch of medicine that treats disease processes through the vascular system, using catheter-based image-guided techniques. Endovascular procedures are minimally invasive, require less or no hospital time, have fewer complications, result in reduced cost, and faster recovery time for the patient.

Dr. Julien and his staff also provide angioplasty, stenting, atherectomy, bypass surgery, embolization and many other vascular treatments.

What is an Interventional Radiologist?
 Interventional radiologists are physicians who specialize in minimally invasive, targeted treatments, offering the most in-depth knowledge of the least invasive treatments available coupled with diagnostic and clinical experience across all specialties. They use X-ray, MRI and other imaging to advance a catheter in the body, such as in an artery, to treat at the source of the disease internally. As the inventors of angioplasty and the catheter-delivered stent, which were first used in the legs to treat peripheral arterial disease, interventional radiologist’s pioneered minimally invasive modern medicine. Many conditions that once required surgery can be treated less invasively by interventional radiologists.

About South Florida Vascular Associates
William H. Julien, MD, is the medical director of South Florida Vascular Associates and is one of few interventional radiologists in the nation to offer a clinical-based practice. His philosophy is to treat the patient as a whole person and he does much of his own testing and procedures in his state-of-the-art facility equipped with three in-office operating suites, allowing patients to feel more comfortable in a non-hospital setting. His highly skilled staff provides one-on-one attention to each patient focusing on his/her needs and care. To learn more about Dr. Julien and South Florida Vascular Associates, call (954) 725-4141 or visit www.southfloridvascular.com.