Non-Invasive Central BP Monitoring & Drug Development
Non-Invasive Central BP Monitoring & Drug Development
Non-Invasive Central BP Monitoring: Improving Efficiency and Success of Drug Development (presented at the Drug Information Association Annual Meeting June 2022)
Incorporation of non-invasively monitored central aortic blood pressure (cBP) into the development program provides opportunities to improve key decisions along the development pathway for cardiovascular products (drug and medical device), particularly those targeting hypertension.
The SphygmoCor® XCEL system is a dual arterial pressure monitoring medical device consisting of brachial blood (peripheral) pressure (pBP) and central aortic blood pressures (cBP, using partial cuff inflation to record the outgoing brachial waveform), which can be obtained in the clinic in the same patient session with as little as 10 additional seconds to a typical pBP assessment. The SphygmoCor XCEL is the only FDA cleared medical device for non-invasive central arterial pressure waveform analysis for all adults.
Central pressures directly impact organs and are generally more highly correlated with end-organ damage and clinical outcomes compared to brachial (peripheral) pressures. These can be captured non-invasively through pressure wave form analysis (PWA). PWA transforms the data from peripheral arterial BP waveforms into an evaluation of central aortic pressures. It also corrects for pressure wave amplification in the upper limb.
For products targeting cardiovascular disease, incorporation of central aortic blood pressure measurement and monitoring into clinical trials can improve key decisions during development (go/no go, endpoints, population characteristics, benefit-risk profile, dosing, etc.) and enhance the likelihood of both regulatory and commercial success.
Download the White Paper
Non-Invasive Central BP Monitoring: Improving Efficiency and Success of Drug Development (presented at the Drug Information Association Annual Meeting June 2022)
Incorporation of non-invasively monitored central aortic blood pressure (cBP) into the development program provides opportunities to improve key decisions along the development pathway for cardiovascular products (drug and medical device), particularly those targeting hypertension.
The SphygmoCor® XCEL system is a dual arterial pressure monitoring medical device consisting of brachial blood (peripheral) pressure (pBP) and central aortic blood pressures (cBP, using partial cuff inflation to record the outgoing brachial waveform), which can be obtained in the clinic in the same patient session with as little as 10 additional seconds to a typical pBP assessment. The SphygmoCor XCEL is the only FDA cleared medical device for non-invasive central arterial pressure waveform analysis for all adults.
Central pressures directly impact organs and are generally more highly correlated with end-organ damage and clinical outcomes compared to brachial (peripheral) pressures. These can be captured non-invasively through pressure wave form analysis (PWA). PWA transforms the data from peripheral arterial BP waveforms into an evaluation of central aortic pressures. It also corrects for pressure wave amplification in the upper limb.
For products targeting cardiovascular disease, incorporation of central aortic blood pressure measurement and monitoring into clinical trials can improve key decisions during development (go/no go, endpoints, population characteristics, benefit-risk profile, dosing, etc.) and enhance the likelihood of both regulatory and commercial success.