Cardiovascular Systems enrols first patients in OPTIMIZE study

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The first two patients have been enrolled in Cardiovascular Systems’ OPTIMIZE peripheral orbital atherectomy system 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.

Specifically, the study will look at patients with calcified below-the-knee lesions. OPTIMIZE will also compare the economic outcomes between the patient groups. Marianne Brodmann, director of the Division of Angiology, Medical University of Graz, Austria, performed the first procedure on 28 October together with Hannes Deutschmann, director of the Vascular and Interventional Department of Radiology, Medical University of Graz, Austria, and Franz Hafner.

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

OPTIMIZE is a prospective, randomised, multicentre, post-market pilot study using the peripheral orbital atherectomy system 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 peripheral arterial disease may benefit from treatment with orbital atherectomy utilising the peripheral orbital atherectomy system, minimally invasive catheter systems developed and manufactured by Cardiovascular Systems. 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. According to a Cardiovascular Systems press release, 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 minimising the adverse consequences of peripheral arterial disease for the millions of people afflicted with the disease,” said David L Martin, Cardiovascular Systems president and chief executive officer. “Our goal is to show that for calcified below-the-knee arteries, pre-treatment with orbital atherectomy followed with DCB, will provide incremental benefits versus DCB angioplasty alone.”