Medtronic has released a synopsis of clinical data on the Endeavor drug-eluting coronary stent to be presented to a U.S. FDA advisory panel on Oct. 10.
The Medtronic announcement was made in conjunction with the release of FDA Advisory Panel materials and includes a pooled data analysis of the major trials encompassing the Endeavor clinical program as well as newly released nine-month results from the Endeavor IV clinical trial. The panel will consider whether to recommend approval of the device to the FDA, which is also subject to FDA approval.
According to its release, Medtronic will present the following results from the Endeavor I-IV clinical trials:
- “Endeavor demonstrates superior reduction in restenosis compared with a bare metal stent that is sustained over time.”
- Endeavor reduced restenosis in patients by more than 60 percent over its bare metal stent comparator, the Driver, at nine months.
- The reduction in restenosis is sustained over time as Endeavor shows a 92.8 percent freedom from Target Lesion Revascularization at three years, less than 8 percent of patients had to return for a repeat revascularization.
- “A unique, long-term safety profile has been established on the Endeavor stent.”
- Low rates of cardiac death, myocardial infarction and stent thrombosis are confirmed with long-term follow-up to three years.
- 99 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 at three years.
- There is no evidence of increased stent thrombosis risk within one year or in years one to three in patients treated with the Endeavor stent compared with those treated with the Driver bare metal stent.
The FDA documents concur that in one of pivotal studies of the new stent, Endeavor IV, 0.8 percent of patients who received Medtronic's stent suffered a thrombosis within nine months of implantation, but those results do not compare well with 0.1 percent of Taxus patients. That FDA documents also propose that Endeavor did not perform as well as Taxus on a secondary angiographic endpoint.
Thrombosis, myocardial infarction and death were the three main concerns raised at an FDA advisory panel meeting held at the end of last year to discuss the safety of Taxus and Johnson & Johnson's sirolimus-eluting product from Cordis.