A federal advisory panel of outside experts unanimously recommended that the U.S. FDA regulators approve Medtronic’s Endeavor drug-eluting stent, along with a requirement for follow-up safety studies, according to Karen Riley, an FDA spokeswoman.
If the FDA accepts the advisory panel’s proposal, Medtronic will be the third drug-eluting stent to enter the U.S. market. The New York Times (NYT) reported that the FDA panel is expected to accept the recommendation, and if it does, Medtronic is expected to release Endeavor by year’s end.
Earlier this week, Medtronic had announced a synopsis of clinical data on the Endeavor drug-eluting coronary stent to be presented to an FDA advisory panel. Documents published by the FDA reviewer for Medtronic's dossiers suggest that the agency believes that Endeavor is slightly more likely to be associated with one form of thrombosis than Boston Scientific's Taxus (paclitaxel) device.
The Medtronic announcement was made in conjunction with the release of FDA advisory panel materials from the FDA 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 company presented 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 the 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. 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 Boston Scientific’s Taxus paclitaxel-eluting stent and Johnson & Johnson's subsidiary Cordis’ Cypher sirolimus-eluting stent.
The panelists also suggested that Medtronic should be required to track the health of 5,000 patients with the device for at least five years.
NYT reported that Endeavor could attain between 12 and 18 percent of the domestic drug-eluting stent market in the first year. The only aspect that could interfere with Medtronic’s projected sales is the introduction of a fourth drug-coated stent, Xience V from Abbot Laboratories, according to NYT.