Solo Pace Inc.
Solo Pace Inc. provides temporary pacing technology designed exclusively for transcatheter heart valve (THV) procedures. Its SoloPace FUSION™ System integrates guide wire functionality, left-ventricular pacing, and patient grounding into a single sterile kit, eliminating the need for additional venous access or improvised pacing setups. The system is FDA 510(k) cleared and commercially available in the US, with Merit Medical serving as the exclusive US distributor.
- Medical Devices
- Healthcare Technology
- Hardware
Funding
Founders
Founder details are not available yet.
Product
Problem
Transcatheter heart valve (THV) procedures require temporary pacing during valve deployment, but conventional pacing approaches lack precision and integration, increasing procedural complexity and patient risk. Conventional right-ventricular pacing leads require additional venous access, while improvised left-ventricular pacing setups rely on ad-hoc clip assemblies, subcutaneous needles, and exposed wire connections that are sources of inconsistent pace capture and workflow variability.
Solution
Solo Pace offers temporary pacing technology engineered exclusively for THV procedures, combining precise control with innovative product design to modernize pacing during valve deployment. The SoloPace FUSION™ System is a fully integrated sterile kit that combines guide wire functionality, left-ventricular pacing, and patient grounding in one device, streamlining the THV device delivery and temporary intracardiac pacing workflow. The system includes a specialized pacing wire designed to balance valve alignment and deployment mechanics with the electrical demands of a unipolar pacing circuit, an integration cable that ensures proper polarity, a grounding pad that replaces subcutaneous needles and alligator clips, and a single-use remote control module that allows operators to initiate, adjust, and terminate rapid LV pacing directly from the sterile field. The system works with the SoloPace CONTROL™ external pulse generator, which provides customizable, automated rapid and backup pacing workflows, automated continuity and pace capture checks, and programmable profiles for multiple operators.
Target Audience
Primary users are interventional cardiologists and structural heart teams performing transcatheter aortic valve replacement (TAVR) and other THV procedures in hospital catheterization laboratories, along with cath lab teams and hospital stakeholders focused on procedural efficiency, safety, and standardization.
Features
- Fully integrated sterile kit combining THV device delivery and temporary intracardiac pacing in one system, eliminating the need for RV lead placement and additional venous access
- Purpose-built pacing guide wire (0.034 inch outer diameter, 275 cm length) with PTFE and proprietary insulative shaft coating, designed specifically for LV pacing during valve deployment
- Validated unipolar pacing circuit with integration cable and grounding pad, replacing improvised clip assemblies, subcutaneous needles, and exposed wire connections
- Single-use remote control module (RCM) enabling operator control of the external pulse generator from the sterile field via Bluetooth, minimizing communication burden
- SoloPace CONTROL™ external pulse generator with programmable operator profiles, automated continuity and pace capture checks, customizable pacing algorithms, and compatibility with patient cables for all common procedural pacing methods
- FDA 510(k) cleared and commercially released in the US, with Merit Medical as exclusive US distributor