Cardiovascular Systems launches combined Diamondback 360, DES trial

Cardiovascular Systems (NSDQ:CSII) said today it enrolled the 1st patient in the Eclipse clinical trial of its Diamondback 360 coronary orbital atherectomy system. The St. Paul, Minn.-based company is looking to enroll 2,000 patients in the trial which aims to explore the use of the Diamondback 360 device for treating patients with severely calcified coronary lesions prior to drug-eluting stent placement. A control group will consist of patients treated with conventional angioplasty, including specialty balloons, prior to DES placement, the comapny said. The trial’s primary endpoint will be post-procedural minimal cross-sectional area as well as target vessel failure at 1 year, Cardiovascular Systems said. “Many of us feel that coronary atherectomy is underutilized, particularly given the increasing complexity of lesions and patients seen in current-day interventional practice. Eclipse is the largest randomized clinical trial to date expressly designed to assess the utility of adjunctive coronary atherectomy for calcific CAD,” principal investigators Dr. Ajay Kirtane of the New York-Presbyterian/Columbia University Irving Medical Center said in a prepared statement. “Coronary calcification has been shown to increase procedural difficulty and adverse events following conventional percutaneous coronary intervention. The use of orbital atherectomy has the ability to significantly modify lesion morphology, enabling successful stent delivery to help optim...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Catheters Clinical Trials Cardiovascular Systems Inc. Source Type: news