Number To Know…2,000
Up to 2,000 patients will be enrolled in Cardiovascular Systems' US pivotal study of its artherectomy system.
2,000 is the number of patients Cardiovascular Systems plans to enroll in its ECLIPSE Coronary Clinical Trial utilizing the Diamondback 360 Coronary Orbital Artherectomy System (OAS). The ECLIPSE study recently enrolled its first subject at St. Francis Hospital in Roslyn, New York. Half the participants will receive orbital atherectomy prior to DES implantation, while the other half will receive conventional angioplasty, including specialty balloons, followed by DES implantation. The trial is powered to demonstrate differences in the primary endpoints of post-procedural minimal cross-sectional area (assessed by intravascular imaging in a subset of up to 400 patients) as well as in the clinical outcome of target vessel failure at one year. ECLIPSE will also evaluate key health economic outcomes.
Meddevicetracker subscribers can access a full analysis of Cardiovascular System's product portfolio including the clinical and regulatory status of the Diamondback 360 Coronary Orbital Artherectomy System here.
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