New stent hits setback
- Pioneer Press, MN
10/06/2007 - The waters got a little choppy on Friday for Medtronic's Endeavor stent as federal reviewers raised questions about the medical device in advance of an important meeting next week.
The U.S. Food and Drug Administration released summary data Friday from a study that suggested a greater incidence of blood-clot problems for patients who received the Medtronic product compared with those treated with the top-selling Taxus stent, which Boston Scientific makes in Maple Grove.
The entire market for drug-coated stents has been rocked in the past year by concerns about blood clots. Fridley-based Medtronic has been highlighting Endeavor's safety record as a potential advantage over competitors.
Stents are metal mesh tubes used to prop open-heart arteries. Since they were first introduced in the U.S. in 2003, and 2004, drug-coated stents have been used more widely than bare-metal stents because the medication coating can prevent the need for repeat procedures.
The data released Friday is for an advisory committee meeting next week on Medtronic's request to market Endeavor in the U.S.
Tim Nelson, an analyst with Piper Jaffray in Minneapolis, said the blood clot data was surprising but not a fatal flaw for Endeavor, since the finding related to patients who developed blood clots within six months of receiving the stent. The real safety concern in drug-coated stents has involved clots forming more than a year after implantation.
"It doesn't say anything about late stent thrombosis, which is the real safety risk that the whole market is concerned about," he said.
But other analysts took a more negative view of the news.
Dr. Alex Arrow, an analyst with Lazard Capital Markets, said in a note to investors that Medtronic now faces some uncertainty at next week's advisory panel meeting. "There is an outside near-term risk that the FDA panel may vote to reject the Endeavor stent application or ask for more data," he said.
Scott Ward, president of Medtronic's cardiovascular division, said the apparent difference in blood clot incidence noted by FDA was not statistically significant. What's more, the blood clots in patients with the Endeavor stent apparently involved mechanical problems with how the stents were implanted - not with the stent itself, Ward said.
More broadly, studies have shown that Endeavor has a very good safety profile, he said.
"We continue to be very confident about our data, and we think we have enough data for the panel to give a complete consideration for this product," he said.
Medtronic is on a faster track to approval in the U.S. than is Illinois-based Abbott Laboratories. Both companies are looking to crack a U.S. market in which only two companies have approval to sell drug-coated stents - Boston Scientific and New Jersey-based Johnson & Johnson.
Medtronic, which currently sells bare-metal stents in the U.S., expects about $30 million in U.S. sales per month once Endeavor hits the market. Analysts expect that Endeavor will take about 15 percent of the U.S. stent market, but Ward said Friday: "We think we can do better than that."
The market for drug-coated stents has softened in the past year with the blood clot concerns. Still, Taxus generated more than $2.3 billion in revenue worldwide during 2006 for Boston Scientific.
Boston Scientific shares closed Friday up 34 cents at $14.26, an increase of more than 2 percent. Medtronic shares closed down $1.10 - or 1.9 percent - at $55.90.
If you or a loved one have been injured during surgical placement of a stent or have been injured as a result of an implanted drug eluting stent (drug coated stent) such as the Boston Scientific Taxus stent or the Johnson & Johnson Cypher stent you may be entitled to compensation. To learn more about the stent recalls, for information regarding your legal rights, or the possiblilty of a class action lawsuit contact our stent lawyers for a free, confidential, case evaluation today. Fill out our online case evaluation form or call us toll free at 1-800-856-6405. |
