First Patients Enrolled in European OPTIMIZE Study of CSI's Orbital Atherectomy System

October 29, 2015—Cardiovascular Systems, Inc. (CSI) announced that the first two patients have been enrolled in its OPTIMIZE study of the company’s peripheral orbital atherectomy system (OAS), which is being conducted in Europe.

OPTIMIZE is a prospective, randomized, multicenter, postmarket pilot study using CSI’s peripheral OAS to perform atherectomy procedures in conjunction with drug-coated balloons (DCB). Up to 50 patients may be enrolled at up to 10 study sites across Europe.

CSI stated that the study will evaluate the acute and long-term clinical outcomes of the OAS with adjunctive DCB angioplasty versus DCB angioplasty alone for treatment of patients with peripheral artery disease (PAD)—specifically, calcified below-the-knee (BTK) lesions. Additionally, OPTIMIZE will compare the economic outcomes between the patient groups.

Professor Marianne Brodmann, MD, Director of the Division of Angiology at the Medical University of Graz, Austria, performed the first procedure on October 28 together with Hannes Deutschmann, MD, Director of the Vascular and Interventional Department of Radiology at Medical University of Graz, Austria and Franz Hafner, MD.

In CSI’s press release, Dr. Brodmann commented, “We are excited to spearhead the study of CSI’s orbital atherectomy technology in Europe. BTK 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.”

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