The new U.S. Food and Drug Administration draft guidelines for drug-coated stent heart devices didn't include any surprises for Xtent Inc. (NASDAQ-NMS:XTNT) (XTNT), which has been in talks with the FDA regarding plans for a device it hopes to bring to the U.S., the company's top official said Thursday.
Xtent, a development-stage company based in Menlo Park, Calif., has a novel stent system that delivers very long stents that can be cut to size while in the blood vessel. It isn't estimating when it will launch in the U.S., but may start a key U.S. trial by the end of this year, and has been in close talks with the FDA for the last couple of years.
Xtent's U.S. trial plans were delayed after concerns about safety issues with drug-coated stents erupted in 2006. The FDA held a two-day meeting in December of that year that resulted in clear signals that manufacturers would have to clear higher hurdles in new coated-stent applications, including longer-term data in key trials.
Xtent well understood the FDA's new guidelines, which were formalized in Wednesday's draft guidance, said Gregory Casciaro, Xtent's president and chief executive.
"What I saw in there, and I scrubbed it pretty hard...there was really nothing surprising about what they are asking for," Casciaro said in an interview.
The FDA's draft guidance is open to public comment for 120 days. The agency is planning a public workshop to solicit comment.
Stents are tiny scaffolds that prop open arteries, and coated stents use medication to fight renarrowing. There are three coated stents on the U.S. market, from Boston Scientific Corp. (NYSE:BSX) (BSX), Johnson & Johnson (JNJ) and Medtronic Inc. (NYSE:MDT) (MDT). Abbott Laboratories Inc. (ABT) is awaiting an FDA decision on its coated stent.
The FDA's new stent guidelines don't have bearing for these products, but instead, for applications that are yet to come from companies such as Xtent.
In contrast to the nine months of data J&J and Boston Scientific (NYSE:BSX) had, the FDA now wants a full year of data in key trials, plus "a substantial proportion" of patients followed out to two years, to help scan for issues that could crop up long after stents are implanted. The safety worries that arose in 2006 involved clots that developed a year or more after implantation.
Abbott in late November got a favorable recommendation from an outside panel of experts at the FDA with one year of pivotal trial data and two years of data on 603 patients followed for two years. Of those patients, 422 had Abbott's stent.
Xtent "will be north of that figure" when it submits its application, Casciaro said.
Xtent is aiming to start selling its device in Europe later this year. Shares of the company recently traded up 10 cents to $5.
-By Jon Kamp, Dow Jones Newswires; 312-750-4129; jon.kamp@dowjones.com
(END) Dow Jones Newswires 03-27-08 1238 Copyright (c) 2008 Dow Jones & Company, Inc.
