•Key Data on Treating Coronary Patients with Impaired Renal Function Also Featured in Podium Presentation
•Tibiopedal Peripheral Procedure Highlighted in Interactive Case Study

ST. PAUL, Minn.--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSI), announced new one-year data and an economic analysis from its ORBIT II coronary study in a late-breaking presentation at the 2014 European Association of Percutaneous Cardiovascular Interventions (EuroPCR) conference in Paris, which took place May 20-23, 2014.

Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, presented the data that demonstrated freedom from major adverse cardiac events (MACE) of 84 percent and freedom from target lesion revascularization of 95 percent.

Additionally, Dr. Chambers highlighted key economic statistics revealing that patients treated with the Diamondback 360® Coronary Orbital Atherectomy System (OAS) have been associated with shorter lengths of hospital stay and lower readmission rates than those treated with other atherectomy devices or stenting alone, suggesting an estimated cost savings in excess of $4,000 per patient for the treating institutions. The economic statistics are derived from a medical resource utilization analysis for both the index procedure and related readmission within 30 days of discharge from the ORBIT II clinical trial, compared to Medicare data available at that time, MedPAR data with code 414.4 between October 1, 2011, and September 30, 2012.

David L. Martin, CSI president and chief executive officer, said, “One-year results from the ORBIT II study reaffirm that CSI's orbital atherectomy technology is a safe and effective treatment for severely calcified coronary arteries that also results in durable outcomes. This is critical information for physicians to know, so we’re pleased that EuroPCR selected our data for a late-breaking presentation.”

ORBIT II, CSI’s pivotal study, evaluated the safety and effectiveness of the company’s orbital atherectomy technology in coronary arteries. CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. On October 21, 2013, the company received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360 Coronary OAS as a treatment for severely calcified coronary arteries.

Significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention, and contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used. The poor outcomes include a substantially higher occurrence of death and MACE.

Podium Presentation: Treating Severely Calcified Lesions in Patients with Impaired Renal Function
Dr. Chambers, Dr. Stevan I. Himmelstein, the Stern Cardiovascular Center, Memphis, Tenn., and Dr. Arthur Lee, the Cardiac and Vascular Institute, Gainesville, Fla., also presented new ORBIT II data at a EuroPCR podium presentation. The results detail 30-day outcomes in patients with impaired renal function who were treated with the Diamondback 360 Coronary OAS to prepare severely calcified coronary lesions prior to stent deployment. A key finding was that, despite being an older demographic with longer lengths of calcium, patients with impaired renal function who were pretreated with the OAS had similar rates of procedural success (successful stent delivery and less than 50 percent residual stenosis) compared with patients without impaired renal function.

Tibiopedal Interactive Case Study
In March 2014, the FDA cleared CSI’s new Diamondback 360® 60cm Peripheral OAS device for the treatment of peripheral arterial disease (PAD). The clearance expands treatment options for challenging lesions in the lower leg, often associated with Critical Limb Ischemia (CLI). If left untreated, CLI may result in lower limb amputation.

At EuroPCR, Dr. Arthur Lee presented an interactive case study featuring a 75-year old woman with severely calcified multilevel disease, facing possible amputation. He showed that:
• The Diamondback 360 60cm Peripheral OAS device is 4F compatible, allowing treatment of the entire leg from a 4F tibial access point.
• Use of small access sheaths can reduce procedure times, enable quicker patient recovery and have fewer procedural complications from bleeding, providing additional procedural benefits to patients and physicians.

CSI’s Martin said: “The use of smaller access sheaths also reduces radiation exposure for the patient, physician and staff. Tibiopedal access expands treatment options for the estimated 20 percent of below-the-knee occlusions that are unable to be treated from the traditional femoral artery access site.”

Source: Cardiovascular Systems, Inc.