October 10, 2007 - Medtronic Inc. announced that an FDA advisory committee has recommended the Endeavor drug-eluting stent for conditional approval as a treatment for coronary artery disease, positioning the Endeavor stent to become the first new drug-eluting stent to be introduced in the United States since 2004.
The FDA committee unanimously recommended the Endeavor stent for approval with conditions related to product labeling and post-market study requirements. The committee also suggested the following: the product’s labeling reflect the clinical trial protocol use of dual anti-platelet therapy and the available professional society guidelines on their use; and a post-market single-arm registry of at least 5,000 patients be followed to a minimum of five years with a primary endpoint of very late stent thrombosis (ARC defined) and a secondary endpoint evaluating death and myocardial infarction.
The Endeavor drug-eluting stent is commercially available in more than 100 countries outside the United States. In the United States, it remains an investigational device and is not yet approved for commercial use.
Medtronic presented the advisory committee with clinical data on more than 2,100 patients who have been treated with the Endeavor stent as participants in the ENDEAVOR Clinical Program, including 1,287 patients studied for two years and 675 patients studied for three years. The volume of data from the ENDEAVOR Clinical Program represents the largest body of scientific evidence ever submitted to the FDA to support the approval of a new drug-eluting stent.
Highlights from the clinical studies of the Endeavor stent include the following findings:
- Endeavor reduced restenosis in patients by more than 60 percent over its bare metal stent comparator, Medtronic’s Driver bare metal stent, at nine months.
- The reduction in restenosis is sustained over time as Endeavor showed a 92.8 percent freedom from Target Lesion Revascularization (TLR) at three years, meaning less than 8.0 percent of patients had to return for a repeat procedure in the three years after receiving the stent.
- Endeavor patients had low rates of cardiac death, myocardial infarction (MI) and stent thrombosis with long-term follow-up to three years.
- 99.0 percent of Endeavor clinical patients have survived without a cardiac death beyond three years after implant; 97.3 percent of the Endeavor clinical patients have been free from heart attack (MI) at three years.
- There is no evidence of increased stent thrombosis risk within one year (0.7 percent Endeavor vs. 1.3 percent Driver per ARC definite/probable) or in years one to three (0.1 percent Endeavor vs. 0.2 percent Driver) in patients treated with the Endeavor stent compared with those treated with the Driver bare metal stent.
In the ENDEAVOR IV clinical trial at nine months, the overall stent thrombosis rate was 0.5 percent (protocol defined), and there were no stent thrombosis observed after six months.
For more information: www.medtronic.com