RADIANCE BEGINS BETA RADIATION STUDY IN PERIPHERAL VESSELS.Radiance Medical Systems Inc., (Nasdaq:RADX) has started enrollment in its peripheral vascular clinical study, RAPID (Radiation After PTA PTA or parent-teacher association: see parent education. Is Done). The case was broadcast live recently from OLV Hospital in Aalst, Belgium to the cardiology professionals attending the annual Paris Course on Revascularization ("Euro-PCR") meeting held in Paris. The procedure in the superficial femoral artery ("SFA") was successfully performed by Dr. Maurice Buchbinder, director of Interventional Cardiology at Scripps Memorial Hospital, La Jolla, Calif. and Radiance's Medical Director, assisting was Dr. Guy Heyndrickx of OLV Hospital. RAPID is an international clinical study designed to evaluate the use of larger diameter RDX(TM) Radiation Delivery Systems in the SFA, the primary vessel in the mid and lower leg. The principal investigator is Professor Erich Minar of the University of Vienna History The University was founded on March 12, 1365 by Duke Rudolph IV and his brothers Albert III and Leopold III, hence the additional name "Alma Mater Rudolphina". After the Charles University in Prague, the University of Vienna is the second oldest university in Central , a leading expert in the use of vascular brachytherapy for treatment of peripheral vessels. Within the next few months, Radiance intends to file for an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and ("IDE") with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. ("FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ") to expand the enrollment in the United States to begin a Phase I Study. It is estimated that 500,000 patients are treated annually for peripheral vascular disease Peripheral Vascular Disease Definition Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. , representing an annual market of approximately $500 million. Jeff Thiel, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. said, "We are excited about the opportunity to utilize the RDX in this additional patient population. Because the RDX is a platform technology that is scalable in diameter, we can potentially treat both large and small vessels and may have the ability to treat a broader range of patients than some of the other vascular brachytherapy devices and other restenosis technologies. Peripheral vascular brachytherapy significantly increases the total market potential for the RDX Technology." Radiance Medical Systems develops radiation delivery catheters intended for use in the coronary and peripheral vascular systems to prevent restenosis following the interventional treatment of atherosclerosis. In addition, Radiance markets coronary stents, coronary stent delivery systems and balloon dilatation catheters for coronary applications. For more information, visit http://www.Radiance.net or 949/457-9546. |
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