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News

Radi Medical Systems' PressureWire Certus receives regulatory clearance

Radi Medical Systems : 24 September, 2008  (New Product)
Radi Medical Systems has received regulatory clearance for its PressureWire Certus to measure physiological parameters inside the heart.
PressureWire has previously only been cleared for use in the coronary and peripheral blood vessels. With the new regulatory clearance, PressureWire can be used to assess pressure measurements across heart valves and into various chambers of the heart.

'The availability of PressureWire for use in extra-coronary applications is an important advance,' said Ted Feldman, MD, FSCAI, professor of medicine and director, Cardiac Catheterization Laboratory, Evanston Hospital, Cardiology Division, Evanston, Illinois. 'My own use of PressureWire for assessing transvalvular gradients has made a real difference for patient management.'

In addition to this new application, PressureWire Certus is used in the assessment of Fractional Flow Reserve (FFR). FFR expresses the maximum achievable blood flow in a coronary artery with abnormal stenosis as a fraction of maximum blood flow in the absence of a stenosis.

'Radi continues to make strides to ensure that PressureWire can be used in additional clinical areas as requested by our customers,' commented Jason Rudy, director of marketing of Radi Medical Systems. 'With this additional regulatory clearance, Radi is the only company able to provide a product that can be used in coronary, peripheral and heart pressure measurements via a 0.014inch guidewire.'
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