Several other medical technology companies are currently undertaking trials of various drug-eluting stent
With more than 1,500 subjects, these randomized clinical trials definitively showed that drug-eluting stents
can yield a 70%-90% reduction in restenosis rates across all categories of disease, These trials have documented a profound degree of efficacy in short lesions and long lesions, small vessels and large vessels, diabetic and nondiabetic patients, men and women, subjects with left anterior descending artery lesions and subjects with other lesions, and subjects with overlapping sterns and those with single stents.
Together, these and other factors contribute to the uncertainty surrounding the evolution of the drug-eluting stent
market and the Company's position in it.
The Endeavor PMA sets a new standard for clinical data submitted to the FDA, with data from the largest, most wide-ranging patient population and for patients with the longest follow-up ever submitted to support the safety and efficacy of a new drug-eluting stent
When the analysis also assumed that longer drug-eluting stents
would be available once routine use occurs (in the trial, the longest sirolimus-eluting stents were 18 mm), then the cost excess of the drug-eluting stents
dropped to an average of $136 per patient.
Although it looks like the price of drug-eluting stents
won't change substantially for at least another year, even at current prices they reduce costs for certain high-risk patients and are cost-effective for most patients undergoing percutaneous coronary interventions, said David J.
It would be very serious if we had to avoid surgery [to avoid stopping aspirin] forever in patients with drug-eluting stents
," said David J.
Use of a drug-eluting stent
can "probably be recommended" for the following: treating in-stent restenosis in place of brachytherapy when the existing stent was bare metal; bifurcations when the drug-eluting stent
is placed in the main branch with angioplasty only for the side branch; aorto-ostial lesions; chronic, total occlusions; patients with multivessel disease instead of bypass surgery if they have only simple, focal lesions; and saphenous vein grafts.
And the most current data from studies that compared drug-eluting stents
with bare-metal stents showed that drug-eluting stents
cut the need for target vessel revascularization by about 82%.
Table 34: Leading Players in Japanese Drug-Eluting Stent
They reported in a poster their experience with using a second drug-eluting stent
to treat 86 lesions in 77 patients with restenosis that had occurred in a first drug-eluting stent
Axxion(TM) is the first drug-eluting stent
system that the Group has introduced to the market.