First FDA Clearance of Passive Non-Invasive Technique Could Transform Cardiovascular Medicine.
As one who started out in patient monitoring in 1982, the gold standard for the measurement of blood pressure has been the “invasive line”. I come from the days where I had to set up a “transducer with saline”, and actually teach hemodynamic monitoring during the early days of cardiac outputs. However, there are “issues” with any type of invasive line, hence why the growth of the oscillometric (non-invasive) use. However, this is not as accurate as an invasive line and it also has user issues such as the proper placement of the cuff and the constant inflation and deflation of the actual cuff on the arm. So the fact that Sotera can measure “beat to beat”, not having to inflate and deflate the cuff constantly with it seems with the accuracy of an “invasive” line is pretty well…huge. Again, some may ask, why has this not been done before? Well it may be pretty “disruptive” to a lot of current business models in this space. Then again in the 60/70’s the only way you could measure cardiac output was in the cath-lab using either the Fick or Green Dye method. Then came physicians Jeremy Swan and William Ganz and they figured the way using a thermistor to measure LVEDP and Cardiac Output using the Swan-Ganz catheter. So hat’s off to Sotera to obtaining FDA approval…. this was not just a walk in the park, but had to demonstrate and validate the accuracy and efficacy as compared to long established standards in the industry.
Download New_cNIBP_clearance_PR010-100913Final
