EMMS can now offer a solution to help meet the needs of the ICH S7A/S7B guidelines, which recommend in-vitro testing of human pharmaceuticals for effects on cardiac repolarisation and potential arrhythmogenicity. The guidelines focus on torsades de pointes, a potentially fatal arrhythmia in which the electrocardiographic QT interval is prolonged by drugs that block a subtype of potassium channel (HERG, or human ether-á-go-go related gene). Our system monitors the cardiac action potential from cardiac tissue (e.g., isolated Purkinje fibres), and extracts a number of parameters such as maximum rate of depolarisation, action potential durations, diastolic membrane potential, and upstroke amplitude.
- Multiple fibres can be monitored simultaneously
- Fast sample rate, up to 200 kHz
- Optional pulse generator to pace tissue
- Fully customisable display area
- Overlay of incoming action potentials on a reference control trace
- Fully compliant with GLP and FDA Final Rule 21 CFR Part 11, for submission of electronic records and electronic signatures.
- Safety pharmacology
- Evaluation of drug proarrhythmic potential
eDacq recording Cardiac Action Potential