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 | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major
TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...