Medical device firm Cardiovascular Systems (CSI) has started enrollment of patients in its Optimize, peripheral Orbital Atherectomy System (OAS) study.
Optimize is a prospective, randomized, multi-center and post-market pilot study that is using the firm’s peripheral OAS to carry out atherectomy procedures in conjunction with drug coated balloons.
The company has designed Optimize trial to assess the acute and long-term clinical outcomes of orbital atherectomy with adjunctive drug-coated balloon (DCB) angioplasty against DCB angioplasty alone for treatment of peripheral artery disease (PAD).
To be conducted in the Europe, the company has already enrolled first two patients in the Oprimize trial and is planning to enroll up to 50 subjects at 10 study sites in the continent.
The trial will specifically concentrate on patients with calcified below the knee (BTK) lesions. It will also compare the economic outcomes between the patient groups.
CSI president and CEO David Martin said: "Studying the combination of orbital atherectomy and drug-coated balloon angioplasty is an important step in our commitment to minimizing the adverse consequences of PAD for the millions of people afflicted with the disease.
"Our goal is to show that for calcified BTK arteries, pre-treatment with orbital atherectomy followed with DCB, will provide incremental benefits versus DCB angioplasty alone."
In April this year, CSI obtained approval from the US Food and Drug Administration (FDA) for its new 4 French (4 Fr) 1.25 Solid Diamondback 360 Peripheral Orbital Atherectomy System (OAS) to treat peripheral artery disease (PAD).