Synecor — LATAM Clinical Studies for Next-Gen Cardiac Pacing
Synecor developed innovative leadless cardiac pacing technology aimed at eliminating the complications associated with traditional pacemaker leads. bioaccess® supported clinical studies in Latin America.
Study facts
- Sponsor / company: Synecor
- Indication / area: Cardiac Rhythm Management
- Country: Colombia, Brazil
- Study type: Early Feasibility Study (EFS)
Key metrics
- Trial Type: EFS
- Countries: 2
- Innovation: Leadless
- Outcome: Design validated
The challenge
Traditional pacemaker leads are responsible for significant complications including infection, lead fracture, and venous occlusion. Synecor needed early feasibility data in humans to validate their leadless approach before committing to a full pivotal trial.
bioaccess® solution
bioaccess® managed early feasibility studies across electrophysiology centers in Colombia and Brazil, coordinating device implantation procedures, pacing threshold measurements, and long-term device performance monitoring aligned with cardiac rhythm management regulatory standards.
Results
- Early feasibility implantations completed successfully
- Pacing thresholds and sensing parameters met design specifications
- Leadless design validated as safe in human cardiac anatomy
- Data supported further development investment
- No lead-related complications—validating the core value proposition
Frequently asked
- What did bioaccess® do for Synecor?
- bioaccess® managed early feasibility studies across electrophysiology centers in Colombia and Brazil, coordinating device implantation procedures, pacing threshold measurements, and long-term device performance monitoring aligned with cardiac rhythm management regulatory standards.
- Where was the Synecor Early Feasibility Study (EFS) study run?
- The Synecor Early Feasibility Study (EFS) study was executed in Colombia, Brazil by bioaccess® in the cardiac rhythm management area.
- What was the outcome of the Synecor study?
- Reported outcomes for Synecor's device: Early feasibility implantations completed successfully; Pacing thresholds and sensing parameters met design specifications; Leadless design validated as safe in human cardiac anatomy.
Run a similar trial: Clinical trials in Colombia · Clinical trials in Brazil
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