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Use of PressureWire(R) Yields a More Accurate Assessment of Translesion Pressure Gradients in Peripheral Vasculature, Two New Studies Report
Date:3/28/2008

UPPSALA, Sweden, and WILMINGTON, Mass., March 28 /PRNewswire/ -- Use of a low profile PressureWire yields a more accurate assessment of translesion pressure gradients when compared to catheter-derived pressure gradient (CPG) measurements, according to a paper published in the Journal of Interventional Cardiology (2008; Vol. 20, Issue 1: 63-65).

The authors report that although CPG measurements derived from both a catheter and PressureWire correlated with anatomic stenosis, PressureWire gradient was more accurate in estimating the clinical significance of peripheral arterial lesions, thus reducing the risk of inappropriate intervention. The paper was based on a study of 20 lesions in 16 patients undergoing angiography for peripheral vascular disease.

Entitled "Physiologic Evaluation of Translesion Pressure Gradients in Peripheral Arteries: Comparison of PressureWire and Catheter-Derived Measurements," this study, conducted at the Beth Israel Deaconess Medical Center in Boston, is the first to assess this hypothesis in patients with peripheral arterial occlusive disease.

"We've long suspected that using a 4 or 5 French catheter for measuring pressure gradients would create artifact, simply due to its size relative to the lumen of the vessel," stated Lawrence Garcia, MD, principal investigator. "This study provides confirmation. In 100 percent of the lesions, the PressureWire provided a better physiologic assessment of the pressure gradient, without the interference of the obstruction due to the catheter."

"Due to its small size, just 0.014, and high-fidelity transducer, PressureWire is able to provide results that are far more accurate than those obtained from catheter based systems," said Jim Archetto, Chief Operating Officer for Radi Medical Systems AB. "The Beth Israel study findings are consistent with data from other trials utilizing PressureWire. Once again the data documents PressureWire as the most accurate diagnostic tool for assessing lesion severity."

Using this low profile PressureWire for arterial pressure measurement yields a more accurate assessment of renal artery stenosis (RAS) and translesion pressure gradients (TPG), than other methods, according to a similar study published in the European Heart Journal (2008; Vol. 29, 517-524) and the Journal of Interventional Cardiology (2008; Vol. 20, Issue 1: 63-65).

Entitled "Assessment of renal artery stenosis: side-by-side comparison of angiography and duplex ultrasound with pressure gradient measurements," this study of 56 RAS patients reports that diagnoses based on renal angiography and color duplex ultrasound overestimated the severity of RAS by 38 percent and 55 percent compared with those based on a ratio of distal renal pressure to aortic pressure. The paper, authored by Dr. Benny Drieghe, also concluded that this overestimate was likely the cause of disappointing results of renal angioplasty for renovascular hypertension.

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

Media Contacts:

David Schull or Ian Stone

Russo Partners LLC

+1 212-845-4271

david.schull@russopartnersllc.com

ian.stone@russopartnersllc.com

Jim Archetto

Radi Medical Systems Inc.

+1 877-337-7234 x812

mailto:jim.archetto@radi.se


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SOURCE Radi Medical Systems AB
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