Healthcare Industry News:  fractional flow reserve 

Devices Cardiology FDA

 News Release - September 23, 2008

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

WILMINGTON, Massachusetts, September 23 (HSMN NewsFeed) -- Radi Medical Systems Inc. today announced at the VIVA conference in Las Vegas, NV, that it has received regulatory clearance for its PressureWireŽ Certus to measure physiological parameters inside the heart.

PressureWireŽ has previously only been cleared for use in the coronary and peripheral blood vessels. With the new regulatory clearance, PressureWireŽ can be used to assess pressure measurements across heart valves and into various chambers of the heart.

"The availability of PressureWireŽ 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 PressureWireŽ for assessing transvalvular gradients has made a real difference for patient management."

In addition to this new application, PressureWireŽ 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 PressureWireŽ 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.


Source: Radi Medical Systems

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