Radiance Receives CE Mark for the RDXTM Coronary ... - Endologix

FOR FURTHER INFORMATIONCONTACT STEVE KROLLVICE PRESIDENT OF FINANCE(949) 457-9546Radiance Receives CE Mark for theRDX TM Coronary Radiation Delivery SystemIrvine, California -- Thursday, June 28, 2001 -- Radiance Medical Systems,Inc., (NASDAQ: RADX) today announced CE Mark approval of their RDX TMCoronary Radiation Delivery System. CE Mark status provides Radiance with theregulatory approval required to begin marketing the RDX System in Europe andmany countries throughout the world. The RDX was approved to prevent restenosisin de novo lesions, in stents and in vessels where the blockage has reoccurred(restenosis).The RDX is a balloon catheter based system used to deliver a therapeutic doseof radiation to the artery to prevent restenosis. Since the radiation is encapsulated inthe balloon membrane, and when inflated the radioactive source is apposed to thevessel wall, the device is designed to deliver a more consistent dose to the target tissuein the vessel.Radiance will formally launch the RDX at the Congress of the EuropeanSociety of Cardiology held in Stockholm, Sweden September 1 to 5, 2001. Sales ofthe product are scheduled to begin during the third quarter in a limited launch to keycustomers in select countries. During the fourth quarter, a full-scale product launchwill begin in all European countries and select countries around the world.Commenting on the approval Jeff Thiel, President and CEO of Radiance said,“We are very pleased that we are able to offer this second generation vascularbrachytherapy treatment option to physicians in Europe. Physician familiarity withballoon catheters, vessel apposition, low contained activity and high dose rate makesthe RDX a useful tool in the cardiologists’ fight against restenosis.”-more-13900 Alton Parkway, Suite 122 • Irvine, CA 926181.800.983.2284 • 949.457.9546 • Fax: 949.457.9561www.radiance.net

page 2Radiance is currently conducting the BRITE II Study in the United States forthe treatment of instent restenosis. Enrollment in this trial began in January 2001 andis scheduled to complete enrollment later this year.Radiance Medical Systems, Inc. develops radiation delivery catheters intendedfor use in the cardiovascular or coronary and peripheral vascular systems to preventrestenosis following the interventional treatment of atherosclerosis. In addition,Radiance markets coronary stents, coronary stent delivery systems and balloondilatation catheters for coronary applications. For more information about Radiance,visit the Company’s website at: www.Radiance.net.Except for historical information contained herein, this news release contains forward-lookingstatements, the accuracy of which are necessarily subject to risks and uncertainties. Actual results may beaffected by, among other things, risks and uncertainties related to new product development andintroduction cycles, research and development activities, including failure to demonstrate clinicalefficacy, delays by regulatory authorities, scientific and technical advances by third parties, introductionof competitive products, third party reimbursement and physician training, and other risk factors andmatters set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2000and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2001.# # #