Radi Medical Systems AB and GE Healthcare announced today a development; marketing and sales initiative to integrate Radi Medical Systems AB (Radi) groundbreaking wireless PressureWire(R) Aeris and Fractional Flow Reserve (FFR) technology into GE's Mac-Lab(R) IT hemodynamic recording system. This agreement defines the terms of a development that will bring together GE's proven Mac-Lab IT with first of its kind wireless measurement of FFR from Radi, seamlessly integrating measurement of FFR into the cathlab workflow and with all procedural results stored into existing data archives. The initiative will also provide an upgrade path for GE Mac-Lab IT customers to add this functionality to their existing systems.
          "Traditionally, FFR assessment required additional capital equipment and increased procedure time due to setup operations." commented Dr. Jasvindar Singh, Associate Professor of Medicine at Washington University School of Medicine, Barnes Jewish Hospital, St. Louis, MO. "With FFR fully integrated into our GE Mac-Lab IT, I'll be able to make the best treatment options
immediately available to my patients using equipment we already have, without any installation of additional instrumentation, screens or controls. Additionally, the wireless technology of PressureWire(R) Aeris removes cables crossing the sterile field barrier, making the entire procedure faster and easier."
          The cooperation will enable the option of upgrading to wireless measurement and integrated FFR on all existing and new GE Mac-Lab IT installations.
          "Combining the strength of GE's Mac-Lab hemodynamic recording system with the performance of Radi's Pressurewire(R) Aeris in the assessment of FFR has great clinical potential," said Pascale Witz, vice president of GE Healthcare's Interventional Cardiology business. "We're pleased to enter into a relationship that expands the clinical capabilities of our systems with new
possibilities."
          "The incorporation of FFR and PressureWire(R) Aeris into GE Mac-Lab IT is a major advancement as FFR becomes the standard of care in the interventional cathlab. With FFR available directly in the existing hemodynamic recording system the need for additional equipment is removed and the procedure setup is reduced to the flick of a switch," commented Anders Qvarnstrom, COO, Radi Medical Systems AB. "FFR is a crucial clinical tool for the interventional cardiologist, guiding the PCI procedure for improved patient outcomes and lowered cost. With the introduction of our innovative wireless PressureWire(R) Aeris and the cooperation with GE, the market leader in hemodynamic recording systems, we can make this tool readily available in a large number of cathlabs worldwide. The ultimate benefactor of this cooperation will be the patient."

          About Fractional Flow Reserve (FFR)
          Fractional Flow Reserve (FFR) is an index for functional severity of coronary stenosis, measured by PressureWire(R) Aeris. FFR is 100% specific in identifying which lesion or lesions are responsible for a patient's ischemia, enabling the interventional cardiologist's direction of coronary interventions and result assessment for improved treatment outcomes. The results of the latest landmark study to demonstrate the clinical value of FFR, FAME, will be presented at the Late Breaking Clinical Trials session,
TCT, October 14, 2008.

 

          About Radi Medical Systems AB
          Radi Medical Systems AB 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 380 people globally and has representation in more than 60  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.

          About GE Healthcare
          GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine
new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
          GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people
committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at http://www.gehealthcare.com.

          SOURCE: Radi Medical Systems AB

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