Radi Medical Systems Inc. Announces Regulatory Clearance of PressureWire(R) Certus for Physiological Parameter Measurements Inside the Heart



    WILMINGTON, MA, Sept. 23 /CNW/ - Radi Medical Systems Inc. today
announced at the VIVA conference in Las Vegas, NV, that it has received
regulatory clearance for its PressureWire(R) Certus to measure physiological
parameters inside the heart.
    PressureWire(R) has previously only been cleared for use in the coronary
and peripheral blood vessels. With the new regulatory clearance,
PressureWire(R) can be used to assess pressure measurements across heart
valves and into various chambers of the heart.
    "The availability of PressureWire(R) for use in extra-coronary
applications is an important advance," said Ted Feldman, M.D., FSCAI,
Professor of Medicine and Director, Cardiac Catheterization Laboratory,
Evanston Hospital, Cardiology Division, Evanston, IL. "My own use of
PressureWire(R) for assessing transvalvular gradients has made a real
difference for patient management."
    In addition to this new application, PressureWire(R) 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(R) can be
used in additional clinical areas as requested by our customers," commented
Jason Rudy, Director of Marketing of Radi Medical Systems, Inc. "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 0.014" guidewire."

    About Radi Medical Systems AB

    Radi Medical Systems AB (Radi) develops, manufactures and sells medical
devices designed to improve patient care. The company's pioneering work in the
field of interventional cardiology has resulted in market-leading
intravascular sensors and hemostasis management and radiology devices. Radi
works closely with medical practitioners to develop solutions that address
clinical needs, as well as provide clinical education support. Founded in
1988, Radi employs more than 350 people globally and has representation in
more than 40 countries. The company is based in Uppsala, Sweden, and maintains
a U.S. headquarters in Wilmington, MA.

    For more information, visit http://www.radi.se.





For further information:

For further information: Media Contacts: Jason Rudy, Radi Medical
Systems Inc., (877) 337-7234 x828, jason.rudy@radi.se; Ian Stone, Russo
Partners LLC, (619) 814-3510, ian.stone@russopartnersllc.com

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RADI MEDICAL SYSTEMS AB

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