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

Wednesday, September 24, 2008 General News J E 4
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WILMINGTON, Massachusetts, September 23 Radi MedicalSystems Inc. today announced at the VIVA conference in Las Vegas, NV, that ithas received regulatory clearance for its PressureWire(R) Certus to measurephysiological parameters inside the heart.

PressureWire(R) has previously only been cleared for use in the coronaryand peripheral blood vessels. With the new regulatory clearance,PressureWire(R) can be used to assess pressure measurements across heartvalves and into various chambers of the heart.

"The availability of PressureWire(R) for use in extra-coronaryapplications 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 ofPressureWire(R) for assessing transvalvular gradients has made a realdifference for patient management."

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

"Radi continues to make strides to ensure that PressureWire(R) can beused in additional clinical areas as requested by our customers," commentedJason Rudy, Director of Marketing of Radi Medical Systems, Inc. "With thisadditional regulatory clearance, Radi is the only company able to provide aproduct that can be used in coronary, peripheral and heart pressuremeasurements via a 0.014" guidewire."

About Radi Medical Systems AB

Radi Medical Systems AB (Radi) develops, manufactures and sells medicaldevices designed to improve patient care. The company's pioneering work inthe field of interventional cardiology has resulted in market-leadingintravascular sensors and hemostasis management and radiology devices. Radiworks closely with medical practitioners to develop solutions that addressclinical needs, as well as provide clinical education support. Founded in1988, Radi employs more than 350 people globally and has representation inmore than 40 countries. The company is based in Uppsala, Sweden, andmaintains a U.S. headquarters in Wilmington, MA.

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

SOURCE Radi Medical Systems AB
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