News | Atherectomy Devices | November 03, 2015

Cardiovascular Systems Enrolls First Patients in OPTIMIZE Study

Study to assess acute and long-term clinical results of peripheral orbital atherectomy with adjunctive drug-coated balloon angioplasty versus drug-coated balloon angioplasty alone

CSI, OPTIMIZE study, peripheral orbital atherectomy system, peripheral artery disease, PAD

Diamondback 360 orbital atherectomy system. Image courtesy of Cardiovascular Systems Inc.


November 3, 2015 — Cardiovascular Systems Inc. (CSI) announced last week that the first two patients have been enrolled in its OPTIMIZE, peripheral Orbital Atherectomy System (OAS) 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 (PAD). Specifically, the study will look at patients with calcified below the knee (BTK) lesions. OPTIMIZE also will compare the economic outcomes between the patient groups.

Prof. Marianne Brodmann, M.D., director of the Division of Angiology, Medical University of Graz, Austria, performed the first procedure on Oct. 28 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 CSI’s orbital atherectomy technology in Europe,” said Brodmann. “Below-the-knee 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.”

OPTIMIZE is a prospective, randomized, multi-center, post-market pilot study using CSI’s peripheral OAS 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 PAD may benefit from treatment with orbital atherectomy utilizing the peripheral OAS, minimally invasive catheter systems developed and manufactured by CSI. 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. 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.

The national principal investigators for OPTIMIZE are Brodmann; Prof. Gunnar Tepe, M.D., Klinikum Rosenheim, Germany; and Prof. Thomas Zeller, M.D., Herz-Zentrum Bad Krozingen, Germany.

For more information: www.csi360.com


Related Content

News | Atherectomy Devices

Medtronic recently announced results from two studies evaluating the utility of atherectomy for peripheral endovascular ...

Home November 08, 2024
Home
News | Atherectomy Devices

February 15, 2023 — Abbott and Cardiovascular Systems, Inc. (CSI), announced a definitive agreement for Abbott to ...

Home February 15, 2023
Home
News | Atherectomy Devices

July 28, 2022 — Northeast Scientific Inc., pioneers in reprocessing single use peripheral vascular catheters, announced ...

Home July 28, 2022
Home
News | Atherectomy Devices

March 9, 2022 — Medtronic is recalling (correcting) the TurboHawk Plus Directional Atherectomy System due to design ...

Home March 09, 2022
Home
News | Atherectomy Devices

January, 24, 2022 — Medtronic Inc. is recalling its HawkOne Directional Atherectomy System product due to the risk of ...

Home January 24, 2022
Home
News | Atherectomy Devices

January 10, 2022 — Cardiovascular Systems Inc. (CSI) is recalling the Wirion atherectomy embolic protection device ...

Home January 10, 2022
Home
News | Atherectomy Devices

July 20, 2020 – BD (Becton, Dickinson and Company) recently completed the acquisition of Straub Medical AG, a privately ...

Home July 20, 2020
Home
News | Atherectomy Devices

February 13, 2020 — The U.S. Food and Drug Administration (FDA) has issued its final guidance on "Peripheral Vascular ...

Home February 13, 2020
Home
News | Atherectomy Devices

November 7, 2019 — The REVEAL FDA investigational device exemption (IDE) trial confirmed a favorable safety and ...

Home November 11, 2019
Home
News | Atherectomy Devices

November 7, 2019 — There was no difference between drug-coated balloons (DCB) vs. plain old balloon angioplasty (POBA) ...

Home November 07, 2019
Home
Subscribe Now