The pump is being used as part of an FDA-approved early feasibility study, according to a June 7 press release.
Patients with severe coronary artery disease often receive mechanical circulatory support during a catheterization procedure. The duration of the procedure is often short, and patients are ambulatory soon after, so devices with smaller insertion profiles are important to minimize vascular access complications, according to the release.
The study was approved by the FDA to evaluate the safety and feasibility of the Elevate system in providing temporary mechanical circulatory support during high-risk percutaneous coronary intervention procedures.
The debut procedures were performed by cardiologists Samin Sharma, MD, and Richard Shlofmitz, MD.
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