CYPHER Sirolimus Drug-Eluting Coronary Stent with SurModics Coating Receives FDA Approval; SurModics Expects Initial Royalties in the September Quarter.Business Editors/Health/Medical Writers EDEN PRAIRIE Eden Prairie A city of eastern Minnesota, a residential suburb of Minneapolis. Population: 57,300. , Minn.--(BUSINESS WIRE)--April 24, 2003 SurModics, Inc. (Nasdaq:SRDX), announced today that Cordis Corporation, a Johnson & Johnson company, has received U.S. Food and Drug Administration (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. ) approval for the CYPHER See cipher. (TM) Sirolimus-eluting Coronary Stent sirolimus-eluting coronary stent Cardiology A coronary artery stent graft which has sirolimus, an imunosuppressive and antimitotic agent incorporated into its matrix, which significantly ↓ restenosis of stents. See RAVEL. that uses SurModics' patented, drug-eluting coating. "The CYPHER Stent is expected to revolutionize the way doctors treat coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. , and this approval is a significant treatment advance for cardiac patients in the United States," said Dale Olseth, Chairman and Chief Executive Officer of SurModics. "We are pleased to collaborate with Cordis on this exciting product." The CYPHER Stent is designed to help reduce restenosis (re-blockage) of coronary artery coronary artery n. 1. An artery with origin in the right aortic sinus; with distribution to the right side of the heart in the coronary sulcus, and with branches to the right atrium and ventricle, including the atrioventricular branches and lesions in patients with coronary artery disease. The CYPHER Stent received CE mark approval for sale in Europe in April 2002, and is the first drug-eluting stent to gain U.S. approval. SurModics expects to begin receiving royalties from U.S. sales of the drug-eluting stent in the September quarter of 2003. In August 2002, the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and took the unusual step of establishing reimbursement codes for the new drug-eluting stents prior to FDA approval. As a result, Medicare reimbursement for the CYPHER Stent will be available immediately. Stents, which resemble wire-mesh tubes, are used to hold arteries open after angioplasty procedures. The new Cordis stent uses SurModics' coating to provide controlled release of specialized drugs that significantly reduced restenosis in clinical trials. About 800,000 Americans undergo coronary interventions involving stent placement each year, according to the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. . Of those patients, more than 150,000 - 200,000 are expected to undergo repeat treatment within one year. Drug-eluting stents have the potential to virtually eliminate such problems and analysts predict the stent market will double in size, reaching $5 billion within the next two years. Researchers announced 1-year clinical follow-up results from SIRIUS, the pivotal U.S. clinical trial for the SurModics-coated CYPHER Sirolimus-eluting Stent produced by Cordis, on March 31 at the American College of Cardiology 52nd Scientific Session in Chicago. The results were consistent with their previous trials, with more than 95 percent of patients treated with the CYPHER Stent experiencing no restenosis. About SurModics, Inc. SurModics, Inc., a leading provider of surface modification technology, licenses its patented coating processes to medical device manufacturers around the world. A significant portion of SurModics' revenue is generated through royalties on the sale of coated products. SurModics' Internet address is www.surmodics.com. |
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