Ennis & Ennis is dedicated to helping victims of defective and recalled traditional stents as well as the newer drug eluting stents throughout the country. If you or a loved one have been injured as a result of stent malfunction you may be entitled to compensation. For more information about your legal rights or to find out the latest recall information or for a free legal consultation contact our stent injury attorneys today.

- TheHeart.org

07/20/2007- The two companies selling drug-eluting stents (DES) in the US have announced plummeting sales of their devices over the past year. In a webcast announcing the company's second-quarter results earlier this week, Johnson & Johnson (J&J) revealed that sales of the Cypher sirolimus-eluting stent in the US have dropped 41% from this time last year, while Boston Scientific, which released sales figures for its Taxus paclitaxel-eluting stent early, has seen US sales of its device drop 42%. International sales for both companies' devices are also down.

The reports confirm what many operators and analysts have predicted for some time: that interventionalists are using fewer DES out of fears of late stent thrombosis (LST) or because patients can't, for a range of reasons, take the recommended one year of dual antiplatelet therapy that would reduce LST risk. The steep decline likely also reflects an overall reduction in PCI procedures in the wake of COURAGE, presented at the 2007 ACC meeting in March. As reported by heartwire, COURAGE suggested stents were no better than optimal medical treatment in terms of preventing death, MI, or hospitalization for acute coronary syndromes in patients with stable angina.

When he first presented the COURAGE results, primary investigator Dr William Boden (Buffalo General Hospital, NY) predicted the results of COURAGE would need to be "digested" before they might start to have an impact on stent use. Now, commenting on the J&J and Boston Scientific sales reports for heartwire, Boden said he believes the drop represents "a confluence of factors" that emerged in the past eight months, including COURAGE, but also the ESC/WCC 2006 meeting, the FDA panel hearing, and a spate of publications examining stent thrombosis risk with DES.

"Those were in many respects unrelated, but in aggregate, they've all had an effect. They've conspired to cause everybody to have more introspection with respect to how they're approaching decision-making in the choice of stents or even whether stenting should be undertaken as the initial form of treatment," Boden said.

At his own hospital, Boden says DES use is down 10% to 13%, from around 90% to 92% at the end of 2006 to around 70% of overall coronary stents used. " We've been increasingly migrating back toward bare-metal stents over the past three months or so. . . . I think that's pretty reflective of what I'm hearing from some of my colleagues across the country."

During the J&J conference call, J&J's vice president of investor relations, Louise Mehrotra, acknowledged that increased competition from companies selling new DES overseas, which are not yet available in the US, may also have had an impact on stent sales abroad. In the US, J&J believes its market share has actually increased, to 46%, up roughly one percentage point from this time last year and from first-quarter results in 2007. Boston Scientific confirmed in its report Friday that its US market share currently sits at 54%.

Asked whether he thought the trend toward dwindling DES use would continue, Boden said he thought the decline was probably leveling off. He also doesn't rule out an increase in DES use as some of the devices already in use overseas become available in the US.

"One thing we know about physicians, and cardiologists in particular, is that when new devices and new drugs come onto the scene, they like to use them. So very likely what will happen is, as the everolimus stent becomes FDA approved and available for clinical usage, and other stents from other companies come into use, and we have more than two choices for interventionalists, people will instinctively try the new product. Just like when a new pharmacotherapy comes out and is FDA approved, people are very keen to give it a try. So I think it's possible DES usage will go back up."

But Boden insists the impact of the stent-thrombosis debate and even COURAGE has been positive. "If there's been one thing that COURAGE has succeeded in doing, it's in taking the dialogue and discussion to a higher level, and I think that's good for physicians and patients and for our noncardiology colleagues as well."

Boden has also pointed out in the past—as have others—that COURAGE was a trial of initial treatment choice: many patients first treated with optimal medical therapy went on to have stents in the trial. As such, the current decline in stent usage may trend upward with time, a point made by Boston Scientific chief operating officer Paul LaViolette during the company's second-quarter conference call. "A lot of patients are now on more aggressive medical management; history shows us . . . those patients don't tolerate the drugs well, they don't stay on drug protocols long."

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.