EndoSonics and JOMED Announce CE Marking for JOSONICS Intravascular Ultrasound Guided Stent Delivery System
RANCHO CORDOVA, CALIF. (March 25) BUSINESS WIRE -March 25, 1999--EndoSonics Corporation (NASDAQ:ESON) and JOMED AB of Helsingborg, Sweden, today announced approval to CE Mark their jointly developed JOSONICS Flex intravascular ultrasound-guided stent delivery system.
The first integrated diagnostic/therapeutic device approved for marketing in key European countries, the JOSONICS Flex system combines EndoSonics' state-of-the-art electronic imaging catheter with JOMED's stent and balloon technology. The JOSONICS Flex system has the potential of significantly reducing post-angioplasty complications while simplifying and shortening the length of the interventional procedure.
The product will be marketed by JOMED in several major countries and through joint EndoSonics/JOMED distribution partners in Europe, Africa and the Middle East. EndoSonics manufactures the imaging catheter and provides technical sales support to JOMED's sales force under a definitive development and distribution agreement reached between the two companies early this year.
Professor P.W. Serruys, M.D., Ph.D., professor of interventional cardiology at Erasmus University in Rotterdam, said, "I am pleased that EndoSonics and JOMED are pioneering this concept with the first integrated IVUS-guided stent delivery system. It has been proven that IVUS guidance can improve the result of stenting, yielding single digit restenosis rates as outlined in my editorial (European Heart Journal, Vol. 19, August 1998).
"During the Second Cardiovascular Summit in Rotterdam, I was anchorman when David Foley and Marcel van den Brand performed the first direct stenting procedure with the JOSONICS device. We were very quickly able to evaluate the lesion for appropriateness of stenting, deploy and immediately assess adequacy of deployment without predilatation and with one device.
"I feel this unique system can provide critical information to improve clinical outcomes in a cost and time saving manner."
EndoSonics President and Chief Executive Officer Reinhard J. Warnking noted, "Initial clinical cases in which the JOSONICS Flex system has been used have been consistently successful. With this smart, image-guided tool, physicians can expect better patient outcomes."
JOMED President and Chief Executive Officer Tor Peters said adding the JOSONICS Flex system to the company's product line underscores JOMED's focus on introducing proven innovative technology to the European medical community.
"The JOSONICS Flex system enables physicians to utilize a premounted stent while allowing them to immediately assess the results of the procedure and make any necessary adjustments prior to removing the catheter," Peters said. "We're very enthused about the opportunity to take smart therapeutics in Europe to the next level."
EndoSonics Corporation, headquartered in Rancho Cordova, is a leading developer, manufacturer and marketer of intravascular ultrasound (IVUS) imaging products and functional assessment products to assist in the diagnosis and treatment of cardiovascular and peripheral vascular disease.
JOMED AB, with sales in 45 countries and active in interventional cardiology, interventional radiology and minimally invasive cardiac assist, is one of the fastest growing European companies in minimally invasive care.
Except for the historic information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. Actual results may differ significantly from the discussion of such matters in the forward-looking statements. Factors that may cause such difference include, but are not limited to, delays by regulatory authorities, scientific advances by the companies or third parties, the timely availability and acceptance of the companies' new products, the impact of competitive products and pricing, dependence upon key personnel, as well as those factors set forth in EndoSonics' quarterly report on Form 10-Q for the quarter ended Sept. 30, 1998, its Annual Report on Form 10-K for the year ended December 31, 1997, and other filings with the Securities and Exchange Commission.
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CONTACT: EndoSonics Corp.
Richard L. Fischer, 916/861-0132 (CFO)
Tim Mehren, 888/579-0045 (Investor Relations)
or
JOMED AB
Antti Ristinma, +46-42-490.6000
KEYWORD: CALIFORNIA
INDUSTRY KEYWORD: MEDICINE COMPUTERS/ELECTRONICS COMED Today's News
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