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Use of PressureWire(R) Yields a More Accurate Assessment of Translesion Pressure Gradients in Peripheral Vasculature, Two New Studies Report

Saturday, March 29, 2008 General News J E 4
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UPPSALA, Sweden, and WILMINGTON, Mass., March 28 Use of alow profile PressureWire yields a more accurate assessment of translesionpressure gradients when compared to catheter-derived pressure gradient (CPG)measurements, according to a paper published in the Journal of InterventionalCardiology (2008; Vol. 20, Issue 1: 63-65).

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

Entitled "Physiologic Evaluation of Translesion Pressure Gradients inPeripheral Arteries: Comparison of PressureWire and Catheter-DerivedMeasurements," this study, conducted at the Beth Israel Deaconess MedicalCenter in Boston, is the first to assess this hypothesis in patients withperipheral arterial occlusive disease.

"We've long suspected that using a 4 or 5 French catheter for measuringpressure gradients would create artifact, simply due to its size relative tothe lumen of the vessel," stated Lawrence Garcia, MD, principal investigator."This study provides confirmation. In 100 percent of the lesions, thePressureWire provided a better physiologic assessment of the pressuregradient, 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 thoseobtained from catheter based systems," said Jim Archetto, Chief OperatingOfficer for Radi Medical Systems AB. "The Beth Israel study findings areconsistent with data from other trials utilizing PressureWire. Once again thedata documents PressureWire as the most accurate diagnostic tool for assessinglesion severity."

Using this low profile PressureWire for arterial pressure measurementyields a more accurate assessment of renal artery stenosis (RAS) andtranslesion pressure gradients (TPG), than other methods, according to asimilar 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 ofangiography and duplex ultrasound with pressure gradient measurements," thisstudy of 56 RAS patients reports that diagnoses based on renal angiography andcolor duplex ultrasound overestimated the severity of RAS by 38 percent and 55percent compared with those based on a ratio of distal renal pressure toaortic pressure. The paper, authored by Dr. Benny Drieghe, also concluded thatthis overestimate was likely the cause of disappointing results of renalangioplasty for renovascular hypertension.

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 in thefield 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, and maintainsa U.S. headquarters in Wilmington, Mass. For more information, visitwww.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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