CSI Presents Late-Breaking CONFIRM Series Data at VIVA 2012

ST. PAUL, Minn. & LAS VEGAS--(BUSINESS WIRE)--Data presented yesterday from Cardiovascular Systems’ (CSI) (NASDAQ: CSII) CONFIRM study series demonstrate that CSI’s minimally invasive orbital atherectomy system is an effective treatment for peripheral arterial disease (PAD). CSI’s technology protects healthy vessel tissue while removing even the most difficult-to-treat plaque throughout the leg with fewer complications. The study titled “Procedural Effectiveness of Orbital Technology in More Than 3,100 Patients with Infra-inguinal Disease: Results from the CONFIRM Series” was part of a late-breaking presentation at the 2012 Vascular Interventional Advances (VIVA) conference.

“Procedural Effectiveness of Orbital Technology in More Than 3,100 Patients with Infra-inguinal Disease: Results from the CONFIRM Series”

Presenter Dr. Tony Das, Cardiology and Interventional Associates, Dallas, Texas, said: “The CONFIRM series data shows that CSI’s orbital atherectomy system safely removes plaque in calcified lesions. This results in low bail out stent usage, low procedural event rates and improved lesion compliance as measured by low inflation pressures of PTA balloons. Additionally, results may indicate improved long-term outcomes and vessel durability – and we plan to study this further.”

David L. Martin, CSI president and chief executive officer said: “The dataset presented today is the largest ever for PAD. We achieved outstanding clinical results, reinforcing the safety and effectiveness of our orbital atherectomy system in 'real world patients.' Moreover, CONFIRM shows consistent, repeatable results – underscored by safety – across numerous interventional physicians. CONFIRM demonstrates that our technology is an effective PAD treatment for patients and gives physicians the confidence to adopt our system.”

The CONFIRM series consisted of three studies that enrolled more than 3,100 patients with 4,700 lesions at 350 sites across the United States from 2009 to 2011. A majority of the lesions had moderate to severe calcium. During the initial study, physicians treated lesions to maximize the luminal gain, while the second and third study focused on removing calcium to change vessel compliance. Each study utilized a progressively smaller crown which reduced slow flow, vessel closure and spasms.

Results demonstrated that vessel preparation with CSI’s orbital atherectomy system enables low pressure adjunctive balloon angioplasty across the studies, with low procedural events and bail-out stents – which preserve treatment options in the future.

In addition, the use of orbital atherectomy in an office-based lab (OBL) setting produced equally successful results to those in hospital settings. A sub-analysis of 75 patients and 108 lesions treated in four offices produced a final residual stenosis of 11 percent versus 83 percent at baseline. There were no flow-limiting dissections, perforations, distal embolization, or slow flow seen in OBL patients.

Overall Procedural Outcomes


Per Lesion	CONFIRM I n=1,146	CONFIRM II n=1,734	CONFIRM III n=1,886
Mean Inflation	5.7 atms	5.3 atms	5.9 atms
Bail-out Stent (due to dissections)	3.8%	5.8%	5.2%
Perforation	0.9%	0.6%	0.7%
Distal Embolization	n/a	2.2%	2.2%
Vessel Closure	2.1%	1.2%	1.4%

Concluded Martin, “CONFIRM is just one of our 13 peripheral clinical trials. We are an industry leader in clinical data support for our physician customers and we’re dedicated to providing physicians with data to make sound treatment decisions for their patients.”

For more information, visit CSI at VIVA at booth #106, 9:30 a.m. – 4 p.m. on Thursday, Oct. 11.

About Peripheral Arterial Disease

PAD is a life-threatening condition where a fatty material called plaque builds up on the inside walls of the blood vessels that carry blood from the heart to legs and arms. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow to the legs. The risk of PAD increases if a person has one or several of the following: high blood pressure, abnormal cholesterol levels, diabetes, or personal history of heart disease, heart attack or stroke. PAD affects an estimated 8-12 million people in the United States. The disease prevalence increases with age and 12-20 percent of Americans age 65 and older suffer from PAD symptoms. As the U.S. population ages, the prevalence range could reach 16 million in those age 65 and older and 19 million overall by 2050.

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 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, nearly 100,000 of CSI’s devices have been sold to 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 Stealth 360°^® PAD System, Diamondback 360^® PAD System and Predator 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.