FDA OKs Solo Pace’s Temporary Pacing During TAVR

Emerging medtech company Solo Pace has achieved U.S. Food and Drug Administration (FDA) clearance and first-in-human use of its SoloPace control system for temporary pacing in transcatheter aortic valve replacement (TAVR) surgeries.

SoloPace was designed to improve TAVR temporary pacing efficiency and reduce risks.

The first cases were performed this month at Scripps Clinic by Chief of Cardiology, Paul Teirstein, MD and Curtiss Stinis, MD. Dr. Teirstein said SoloPace has modernized pacing during TAVR valve deployment and takes variability out of the surgery by giving the operator full control, while automating ramp-up and back-up algorithms.

“The TAVR procedure is simplified, reducing physician and staff workload,” Dr. Teirstein told the press. “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.”

SoloPace’s operator-specific protocols and automated pace capture checks can improve procedural efficiency, the company believes. Its interface and sterile remote control operation were designed to minimize unnecessary communications errors.

Further, the system is compatible with patient cables for common procedural pacing methods so it can be more easily integrated 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 Solo Pace founder and CEO, David Daniels, MD. “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.”