SoloPace announces US FDA clearance and first-in-human use of TAVI temporary pacing system - Cardiovascular News

Solo Pace’s Temporary Pacing System for TAVR Procedures Cleared by FDA - Cardiac Interventions Today

April 28, 2025—Solo Pace Incorporated recently announced FDA clearance and the first-in-human use of the company’s SoloPace control system for temporary pacing in transcatheter aortic valve replacement (TAVR) procedures. According to the company, the SoloPace control system is engineered to improve TAVR temporary pacing efficiency and reduce patient risks. The device features operator-specific protocols, automated pace capture checks, an intuiti…

SoloPace announces US FDA clearance and first-in-human use of TAVI temporary pacing system - Cardiovascular News

SoloPace Incorporated has announced both US Food and Drug Administration (FDA) clearance and first-in-human use of its SoloPace control system for temporary pacing in transcatheter aortic valve implantation (TAVI) procedures. With standardised workflows, the control system is engineered to improve TAVI temporary pacing efficiency and reduce patient risks, according to a recent company press release. Initial cases were completed this month at Scr…