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J&J Nevo goes head-to-head with Abbott Xience V

This article was originally published in The Gray Sheet

Executive Summary

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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Earnings In Brief

Abbott Q1: Firm's Xience V everolimus-eluting stent's share of the U.S. market has leveled off in the high 20s, but the product continues to be a significant growth driver, Abbott reports during an April 15 first-quarter earnings call. Abbott says its global drug-eluting stent sales tripled to $330 million in the quarter. Boston Scientific markets the same stent under the brand name Promus. Abbott plans to build on the Xience platform with two additional offerings, Xience NANO and Xience Prime, with new clinical trials beginning this year. The former stent is intended for smaller vessels, while the latter offers improved deliverability in longer lesions and complex anatomy, Abbott VP, Investor Relations John Thomas explained. On a reported basis, worldwide vascular sales soared 42.7% to $645 million, including an 84.2% increase in the U.S., where vascular product revenues reached $395 million. Worldwide diagnostics sales rose 6% on an operational basis to $816 million but declined 1.8% on a reported basis

J&J Orthopedic, Surgical Sales Help Offset 12% Cordis Decline In 2008

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 Pipeline Includes Stents, A-Fib Ablation, Percutaneous AAA Repair

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

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