The sun may finally have set on the heyday for coronary stent makers.
Both the Natick, Mass.-based stent pioneer and its peer from Fridley, Minn., could have been forgiven for expecting a positive reaction from investors after the study results dropped at the American College of Cardiology’s annual conference. But the buzz from New Orleans was less that enthused, with some physicians questioning whether the technology behind Medtronic’s Resolute drug-eluting stent and Boston Scientific’s platinum-chromium Promus Element has nearly peaked.
Despite positive two-hear results from a five-year study of its next-generation Promus Element stent, the Natick, Mass.-based medical device maker’s stock slipped 1.2 percent yesterday and opened even lower today, at around $7.18. BSX shares closed out at $7.06 today, down 2.4 percent.
That may be because Boston Scientific and its main stent competitors — Medtronic (down 0.5 percent to $39.25 today), Abbott Laboratories (NYSE:ABT), and Cordis Corp., Johnson & Johnson’s (NYSE:JNJ) stent division — have already reached the outer limits of what the technology can do.
The Medtronic studies showed that its Resolute zotarolimus-eluting stent delivered lower rates of restenosis at one year than its predecessor, the Endeavor stent. Two-year results from an “all comers” study in Europe, where the device has been on the market since 2007, showed that it fared well against Abbott’s Xience V stent.
That two of the industry’s leading “next-generation” products are so similar to their forbears raises the specter of the law of diminishing returns.
“The bar is set very high now,” said Dr. Charles Davidson of Northwestern University’s Feinberg School of Medicine, a panelist at the ACC conference. “There are ways we can continue to improve, but this will require larger trials, with long follow-up, in high-risk patients such as those with ACS, STEMI, and left main.”
“Our procedures continue to get safer; our equipment and devices are getting better. New stents will have to be as safe as approved devices, and when it comes to deciding which stent is better than another, it will come down to nuanced aspects, and these don’t come to light until you are using these devices in lots and lots of people, not in these small trials designed for regulatory approval,” noted Dr. Edward McNulty of the University of California, according to the heartwire blog. “This is the sort of information you get from large registries and from feedback from operators.”
“So how do you choose?” added Dr Martin Leon of Columbia University. “It’s like anything else in life. When you get up in the morning, do you choose a black jacket or a gray jacket? You don’t look for a randomized trial. You’ve got some very good devices that may have subtle differences that may appeal to one individual or another, but it’s going to be difficult to distinguish these devices as being meaningfully different.”
That may be the view on The Street as well.