PMCF is completed: clinical evidence for a one stop-shop for measurement of flow and pressure
The PMCF was intended to demonstrate that by using our MRWire guide wire it is possible to perform both pressure and flow measurements using CMR. This avoids the need for multiple fluoroscopy studies and radiation exposure.
Twenty-five patients were included in the German heart centre in Munich (DHZM). The study protocol can be downloaded here. Final results were presented on February 3rd at the SCMR 2017 meeting at Gaylord Convention Centre in Washington DC (USA). A mix of pressure measurements was done such as pulmonary artery, right ventricle, right atrium and aortic gradient in patients routinely monitored for the status of their congenital heart disease. The study includes 13 male subjects and 12 female subjects, and was conducted without serious adverse events. Abstracts were presented in Rome (AEPC, 2016) and Washington (SCMR, 2017). Download summary here: ExpertReport-PMCF-MRWire.