CardioVascular Dynamics Inc. Receives European CE Mark Approval for Synthesis STAR Coronary Stent Products.IRVINE, Calif.--(BW HealthWire)--Aug. 13, 1998--CardioVascular Dynamics Inc. (Nasdaq:CCVD CCVD Communauté de Communes du Val de Drôme CCVD Combustion Chemical Vapor Deposition ) Thursday announced that it has received notification from the European community European Community: see European Union. European Community (EC) Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community. that all three sizes of the company's next-generation interventional coronary stent coronary stent Intracoronary stent Cardiology An expandable tubular device which can be inserted percutaneously, and left within a coronary artery lumen to maintain its patency Pros Clinical and angiographic outcomes are better with intracoronary artery stent products have received CE Mark approval for sale in Europe. Synthesis STAR System Coronary Stent Product CVD's Synthesis STAR coronary stent products receive CE Mark approval. The Synthesis STAR system is a high-performance, flexible coronary stent device. The company believes that the Synthesis STAR system will exceed customer expectations for the performance characteristics of all conventional stent delivery systems. The Synthesis coronary stent is a multi-celled flexible coronary stent. The Star delivery system is based on CVD's patented focus catheter technology. The integration of these two products represents a new generation of CVD's coronary stent technology. Commenting on the approvals, CVD CVD Cardiovascular disease, see there president and chief executive officer, Jeffrey O'Donnell, said: "These approvals represent a significant milestone for CVD. Our distribution network in Europe has been eagerly awaiting the approval of this product. "The combination of the Synthesis, a more flexible stent, integrated on a new low-profile Focustent delivery system should be very well received by our European customers. The company believes this combination provides a superior method of coronary stenting Coronary Stenting Definition A coronary stent is an artificial support device used in the coronary artery to keep the vessel open. Purpose by both increasing the lumen size of the artery itself and decreasing commonly encountered complications associated with conventional coronary stenting. "CVD will be launching these new products at the upcoming European Society of Cardiology The European Society of Cardiology (ESC) represents more than 50,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the impact of cardiovascular disease in Europe. meeting in Vienna." Except for the historical information contained herein, the matters discussed in this news release may be forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. , the accuracy of which is necessarily subject to risks and uncertainties. The receipt additional of regulatory approvals and clinical efficacy of, manufacturability of and market demand for products, among other matters discussed in this release, may cause actual results to differ significantly from the discussion of such matters in the forward-looking statements. Actual results may be affected by, among other things, delays by regulatory authorities, scientific advances by CVD or third parties, introduction of competitive products, third-party reimbursement and physician training, as well as those risk factors set forth in the CVD Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended Dec. 31, 1997.
CONTACT: CardioVascular Dynamics Inc., Irvine
Stephen R. Kroll, 949/457-9546
|
|
||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion