Along with FDA clearance, the company announced the first-in-human use of the system in a transcatheter aortic valve replacement (TAVR). Designed with standardized workflows, the system improves TAVR temporary pacing efficiency and reduces patient risks.
Dr. Paul Teirstein and Dr. Curtiss Stinis completed the initial cases this month at Scripps Clinic.
“Solo Pace has modernized pacing during TAVR valve deployment. 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,” said Dr. Teirstein. “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 features operator-specific protocols and automated pace capture checks. These help improve procedural efficiency, while an intuitive interface and sterile remote-control operation reduces unnecessary communications errors. Additionally, the system has compatibility with patient cables for all common procedural pacing methods. This makes it easy to integrate into current practice.
“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,” said Dr. David Daniels, Solo Pace Founder and CEO. “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.”
