Medtronic Inc.’s (NYSE:MDT) Resolute drug-eluting stent bested rival Boston Scientific Corp.’s (NYSE:BSX) Taxus DES in rates of in-stent late lumen loss at eight months in patients with coronary artery disease.
The Japanese Resolute study compared 100 patients treated with Medtronic’s DES to 135 patients who received the Taxus stent in the Endeavor IV clinical trial.
The Resolute stent had an in-stent late lumen loss rate of 0.13 mm ±0.22 mm at eight months, compared to 0.42 mm ±0.50 mm for patients with the Taxus stent. Resolute also showed low rates of target lesion failure (4 percent) and no instances of stent thrombosis.
The data will help the Fridley, Minn.-based medical device giant’s bid for Japanese regulatory approval for the Resolute stent. The Japanese stent market is the second-largest in the world after the U.S., according to a press release.
Medtronic presented clinical findings vaunting the Resolute stent’s equivalency and potential superiority over Abbott’s (NYSE:ABT) market-leading Xience V DES at the EuroPCR conference in Paris earlier this year, where Boston Scientific touted its own study boasting the "exceptional safety and effectiveness" of its Promus stent system.
Medtronic, which ranked 5th on the MassDevice Big 100 list of the world’s largest medical device companies, has been waging war in the global stent market against fellow industry giants Abbott (NYSE:ABT), which ranked 1st on the list, and
Boston Scientific Corp. (NYSE:BSX), which ranked 10th.
The conflict is exacerbated by recent studies finding that a small subset of elective coronary stents were potentially unnecessary, which could have a ripple-effect on Wall Street’s confidence in the stent arena.
The Integrity iteration of the Resolute stent won CE Mark approval in the European Union in August, 2010.*
*Correction, July 26, 2011: This article originally stated that the Resolute stent won CE Mark approval in 2010; it won the CE Mark in October 2007. The Resolute Integrity won the mark in August 2010. Return to the corrected sentence.