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

Shockwave Initiates U.S. Pivotal Study for Coronary Intravascular Lithotripsy
News | Cath Lab | January 16, 2019
Shockwave Medical Inc. has initiated its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE...
National Academy of Engineering, Ohio University Award 2019 Russ Prize
News | Cath Lab | January 03, 2019
Ohio University and the National Academy of Engineering announced the 2019 Fritz J. and Dolores H. Russ Prize will be...
Videos | Cath Lab | January 03, 2019
This is a walk through inside one of the cardiac hybrid cath labs at the...
Videos | Cath Lab | January 03, 2019
This is the newest cardiac cath lab at the ...
Study Finds Effective Treatment for Coronary Slow Flow
News | Cath Lab | December 27, 2018
Patients who arrive at the hospital with heart-attack-like symptoms have had little recourse for their chest pain if...
Shockwave Announces Collaboration With Abiomed on Physician Training
News | Cath Lab | December 14, 2018
Shockwave Medical announced a new investment and collaboration agreement with Abiomed Inc. As outlined by the agreement...
Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Overlay Init