Medtronic just announced FDA approval of its Endeavor® Zotarolimus-Eluting Coronary Stent System, the first drug eluting stent approved since 2004. The approval, following a number of controversies in the past years involving drug eluting stents, rests on the condition that Medtronic continues its post-market clinical monitoring program.
From the press release:
The ENDEAVOR clinical program includes seven studies: three randomized controlled trials and four registries. Medtronic’s FDA submission included clinical data on more than 2,100 patients treated with the Endeavor stent, 1,287 of whom were studied to two years and 675 to three years. Highlights from the program include the following results:
Excellent Safety Profile Before and After One Year
Presented at the FDA panel meeting in October, an analysis of pooled safety data from the ENDEAVOR clinical program reported a stent thrombosis rate for Endeavor patients of less than 1 percent within the first year and a remarkably low 0.08 percent from one year to three years post-implant. The same analysis revealed low cumulative rates of all safety measures out to three years of follow-up: stent thrombosis (0.7 percent); myocardial infarction (2.7 percent); and cardiac death (1.0 percent). Importantly, Endeavor has shown numerically fewer adverse events across all key safety measures versus a bare-metal stent. Of particular note from this analysis, just 3.5 percent of Endeavor patients experienced cardiac death or myocardial infarction through three years of follow-up, compared to 6.6 percent of patients who received a bare-metal stent.
Sustained and Consistent Reduction in the Need for Repeat Procedures
The Endeavor stent offers clinical effectiveness that is consistent with the current market-leading drug-eluting stent in the United States. ENDEAVOR IV, the randomized controlled trial comparing the Endeavor stent with Boston Scientific’s Taxus stent, met its primary endpoint, with a target vessel failure (TVF) rate in Endeavor patients of 6.6 percent at nine months. The TVF rate for Taxus patients at nine months was 7.2 percent. Importantly, Endeavor had similar efficacy compared to Taxus for all lesion subsets analyzed, and there were no statistically significant differences in target lesion revascularization (TLR), the clinical measure for repeat procedures. Compared to a bare-metal stent in the ENDEAVOR II clinical trial, the Endeavor stent has been shown to reduce the need for repeat procedures by more than 61 percent at nine months. This treatment effect is sustained, with only 7.3 percent of Endeavor patients in this randomized controlled trial requiring a repeat procedure out to three years of follow-up.
Ultimately, the ENDEAVOR clinical program will enroll more than 22,500 patients followed to five years; approximately 16,630 of these patients will receive an Endeavor stent.
Press release: Medtronic Receives FDA Approval for Endeavor® Zotarolimus-Eluting Coronary Stent System
Link to Medtronic video explaining the technology, showing actual implantation of the stent, and clips of the manufacturing process. Note that the video is over 100 MB in size.