Winners and losers from the cessation of the Cypher and Nevo stent programs

Abstract

Summer is behind us, but clearly it was sizzling with respect to the field of interventional cardiology, especially with the dramatic announcement from Cordis/Johnson & Johnson on the production cessation of the Cypher sirolimus-eluting stent (SES) by the end of 2011 and the abandonment of the development plans for the NEVO SES. The announcement, which stunned the interventional cardiology community, may reflect the end of an era regarding the drug-eluting stent (DES) field and warrants a few editorial comments. The Cypher SES is considered an icon in the DES field; it was the first-ever DES to reduce restenosis when compared to bare metal stents. The manufacturer's rationale for ceasing production of the Cypher stent and abandoning the NEVO program was reported as such: “Targeted dynamics in the DES market that have changed considerably in recent years and continue to evolve in areas such as demand, pricing and reimbursement, and regulatory requirements for breakthrough new technologies. Unlicensed competition from products that infringe Cordis patents, owned and licensed, has eroded CYPHER Stent pricing, sales and market share, and has dampened the prospects for NEVO Stent commercialization.” Indeed, over the past few years, DESs have become a commodity that reflects maturity in a field that began more than a decade ago. For the last decade, fierce competition has led to the development of second-generation stents, which primarily improved the deliverability of the stent when compared to Cypher and perhaps improved the safety with regard to a more compatible polymer. Ironically, when compared to Cypher, even the best second-generation DESs failed to beat Cypher's efficacy in comparative observational registries and in randomized clinical trials. Since the 2003 approval of the Cypher stent for marketing in the US by the FDA, we in the US have not seen any iterations or improvements made to the device. In 2011, Cypher is considered ‘old’ technology by being a firstgeneration DES with a polymer reportedly associated with