In vitro evidence for PFA device development
Pulsed field ablation (PFA) in vitro testing services.
Our PFA testing services combine parameter optimization, tissue-selectivity assessment and Functional Imaging. We support medical device developers from requirements definition and study design through report delivery and technical questions.
Platform capabilities
| Area | Scope |
|---|---|
| Core testing capabilities | Electroporation threshold determination, cardiomyocyte functional assessment, comparisons of tissue selectivity and evaluation of thermal confounding help build an in vitro evidence package for safety, efficacy and submission-related studies. |
| Functional Imaging | High-speed calcium imaging, voltage imaging and appropriate probe systems track changes in cardiomyocyte function and cell viability following irreversible electroporation (IRE), supporting parameter screening and functional assessment. Optical voltage signals are not direct measurements of absolute membrane potential. |
| Regulatory submission experience | Our experience includes testing associated with research by leading international PFA companies and commissioned studies for multiple Chinese PFA device manufacturers. Technical reports can be prepared in formats aligned with the applicable submission requirements. |
Why include in vitro testing in PFA development?
| Area | Scope |
|---|---|
| Regulatory evidence | In vitro safety and efficacy data provide an important foundation for development and submission of Class III medical devices in the Chinese regulatory context. Applicable evidence requirements are determined for the intended submission jurisdiction. |
| Tissue selectivity | Parallel comparison of cardiomyocytes with esophageal smooth muscle cells, vascular endothelial cells and neurons evaluates selective ablation. |
| Parameter optimization | In vitro screening of pulse amplitude, width and frequency helps streamline preclinical development. |
| Thermal-effect boundaries | Temperature monitoring and supporting thermal-effect studies assess and help exclude nonspecific thermal injury as a confounding factor, improving interpretation of the results. |
Core PFA testing modules
| Module | Scope |
|---|---|
| Electroporation thresholds | Quantify IRE electric-field strength thresholds in different cell types and establish relationships between treatment parameters and the extent of injury. |
| Cardiomyocyte function | Use hiPSC-CMs and animal-derived cardiomyocytes to track functional changes and cell viability after PFA in real time. |
| Comparative tissue selectivity | Compare responses in cardiomyocytes, esophageal smooth muscle cells, vascular endothelial cells and neurons to quantify safety windows and selective injury. |
| Assessment of thermal confounding | High-precision temperature monitoring tests whether exposure remains within the intended nonthermal conditions and helps avoid attributing nonspecific thermal injury to electroporation. |
From requirements to testing and reporting
- Step 1: Requirements discussion
1-3 days to confirm the device type and an initial fixture design.
- Step 2: Study design and quotation
3-5 days to define customized testing modules, cell models and delivery criteria.
- Step 3: Experimental work
4-8 weeks to execute the agreed protocol, with interim progress updates and real-time sharing of raw data.
- Step 4: Report delivery
1-2 weeks for the technical report, statistical analysis and interpretation.
- Step 5: Technical support
Support for technical questions throughout the project and prompt responses to requests for supplementary experiments.
Study delivery and research expertise
| Area | Scope |
|---|---|
| Integrated capabilities | Multicell-type selectivity testing, Functional Imaging and PFA parameter optimization are coordinated within one study program. |
| Regulatory-facing experience | Participation in testing-related research for leading international companies provides practical experience in addressing regulatory evidence needs and technical questions; this is not regulatory endorsement. |
| Efficiency and cost flexibility | A flexible, customized service model offers an alternative to international CRO workflows, with the aim of reducing communication overhead, delivery time and overall project cost. |
| Specialist research team | A PhD-level, multidisciplinary team combines neuroscience and cardiovascular research expertise. Reports are available in English and Chinese. |
