Cardiovascular implants safety

Because the monkey is the most sensitive species for the effects on complement, we have opted to perform cardiovascular safety studies as part of subchronic study protocols using implanted telemetry units in selected monkeys (two/sex in at least two different treatment groups, including the high dose) to measure ECG, mean arterial pressure, heart rate, and body temperature. These parameters are then recorded at frequent intervals for a 24-hour period prior to treatment to establish circadian fluctuations and normal response to various stimuli encountered during the day. This technique enables us to assess both acute alterations related to complement activation after single doses and chronic safety after repeated administration. 

---