J&J Nevo goes head-to-head with Abbott Xience V
This article was originally published in The Gray Sheet
Johnson & Johnson/Cordis is preparing a 2,000-patient, randomized study pitting its Nevo sirolimus-eluting coronary stent, which incorporates reservoir-based drug delivery technology, against Abbott's market leading Xience V everolimus-eluting coronary stent, the firm announces March 16. J&J plans to meet with regulators "soon" to finalize the design for the global NEVO II study. In May, the firm will report six-month data from its 394-patient, randomized, NEVO RES I trial comparing Nevo with Boston Scientific's Taxus paclitaxel-eluting stent. A CE mark application will be filed later this year in Europe (1"The Gray Sheet" Jan. 26, 2009, p. 16). In the U.S., the firm's non-randomized, single-arm, 1,000-patient NEVO III study will be the pivotal trial supporting a PMA submission planned for 2011 (2"The Gray Sheet" June 16, 2008, p. 17). J&J notes that it will drop from its development pipeline the Cypher Elite sirolimus-eluting coronary stent to focus on Nevo
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Sales in Johnson & Johnson's devices and diagnostics business in the fourth quarter were down in the U.S. and close to flat worldwide, with revenue from its DePuy orthopedic and Ethicon Endo-Surgery units offsetting a dismal performance from the Cordis franchise
Cordis will file a PMA in 2011 for its Nevo drug-eluting, cobalt chromium coronary stent with reservoir-based delivery technology gained through the 2007 acquisition of Conor Medsystems, the Johnson & Johnson subsidiary says