CSI’s Diamondback 360 Orbital Atherectomy System Evaluated in ECLIPSE Trial

April 3, 2023—Cardiovascular Systems, Inc. (CSI) announced the completion of enrollment for the company’s 2,000-patient ECLIPSE trial evaluating the CSI Diamondback 360 coronary orbital atherectomy system (OAS).

According to CSI, ECLIPSE is a United States prospective, multicenter, randomized clinical trial of 2,000 patients with severely calcified coronary lesions. Half of the participants received orbital atherectomy before drug-eluting stent (DES) implantation, while the other half received conventional angioplasty, including specialty balloons, followed by DES implantation.

The trial is powered to demonstrate differences in the primary endpoints of postprocedural in-stent minimal cross-sectional area (assessed by optical coherence tomography imaging in a subset of approximately 400 patients) and the clinical outcome of target vessel failure at 1 year. ECLIPSE will also evaluate key health economic outcomes.

Results from ECLIPSE are expected to be shared in the fall of 2024, advised the company.

CSI, in partnership with the Cardiovascular Research Foundation, announced the commencement of enrollment in the ECLIPSE trial in March 2017.

The Diamondback 360 coronary OAS has received FDA approval and CE Mark approval. It is indicated to facilitate stent delivery in patients with coronary artery disease who are acceptable candidates for percutaneous transluminal coronary angioplasty or stenting because of de novo, severely calcified coronary artery lesions.