Cardiologist-founded startup announces FDA clearance, first uses of new TAVR pacing system
Solo Pace Incorporated, a San Francisco medtech company, has received U.S. Food and Drug Administration (FDA) clearance for its new technology that delivers temporary pacing during transcatheter aortic valve replacement (TAVR).
The SoloPace Control System was designed to boost the efficiency of TAVR procedures, improving communication through the use of operator-specific protocols and automated pace capture checks. According to Solo Pace, it is compatible with “all common procedural pacing methods,” allowing users to integrate it into their normal workflow without implementing significant changes.
"Precise pacing is essential for safe TAVR procedures, yet today’s devices are not purpose-built for TAVR, offer no standard pre-sets, and require inefficient verbal commands,” interventional cardiologist David Daniels, MD, Solo Pace’s founder and CEO, said in a statement. “FDA clearance and the use of our technology in patients are both significant milestones for the Company and first steps on our journey to advance transcatheter heart valve pacing solutions.”
Cardiologists perform first-in-human procedures using SoloPace Control System
Interventional cardiologists Paul Teirstein, MD, and Curtiss Stinis, MD, of Scripps Health performed the first TAVR procedures using this new technology.
“Solo Pace has modernized pacing during TAVR valve deployment,” Teirstein said in the same statement. “The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms. The TAVR procedure is simplified, reducing physician and staff workload. We pre-program pacer settings to reliably deliver the same procedure every time. This allows us to focus on the patient and free up resources, especially at centers where nurses and technologists currently control the pacemaker generator.”
The SoloPace Control System will be distributed by Merit Medical.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.