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

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Overlay Init