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Medtronic’s Endeavor stent receives US FDA approval and is to begin shipments to US hospitals

Medtronic : 04 February, 2008  (New Product)
Medtronic has received approval from the US Food and Drug Administration (FDA) for the Endeavor Zotarolimus-Eluting Coronary Stent System to be used in the treatment of coronary artery disease.
The approval gives US cardiologists access to a new medical device for safely and effectively treating patients with narrowed coronary arteries.

The Endeavor data encompasses the largest, most wide-ranging patient population submitted to the FDA in support of a drug-eluting stent, including more than 4,100 patients, followed up for as long as four years. The extensive clinical research has shown that Endeavor provides a consistent and sustained reduction in the need for repeat procedures compared to a bare-metal stent, while also maintaining an excellent safety profile. The Endeavor Stent is the first new drug-eluting Stent approved by the FDA since 2004.

Enabling a minimally-invasive alternative to open-heart bypass surgery, stents are tiny wire mesh tubes used to prop open coronary arteries that have been cleared of blockages to restore blood flow to the heart muscle. Drug-eluting stents deliver medication to the artery wall to reduce the chance that the artery will narrow again and require a repeat procedure.

“Endeavor represents a true next-generation drug-eluting Stent because of its unique design, which combines an advanced Stent platform with the potent drug zotarolimus and a biocompatible polymer,” said Dr Martin B Leon, professor of medicine at Columbia University Medical Center in New York, cardiologist at New York-Presbyterian Hospital/Columbia University Medical Center, founder and chairman emeritus of the Cardiovascular Research Foundation, and principal investigator of the Endeavor III and IV clinical trials. “This device addresses an important need by demonstrating comparable clinical effectiveness to a first generation drug-eluting Stent while also exhibiting a safety profile more typical of a bare-metal stent, long considered a benchmark for safety performance. In addition, it has the advantage of being exceptionally easy to deliver through the tortuous vessels of the coronary vasculature. For these reasons, the Endeavor Stent will undoubtedly be a welcome addition to the practice of interventional cardiology in the United States.”

The US market launch of the Endeavor Stent begins immediately. “We have been strengthening our field and manufacturing capabilities in anticipation of considerable demand for the Endeavor Stent in the United States,” said Scott Ward, president of the CardioVascular business at Medtronic. “We expect to ship 100,000 units to US hospitals in the next 30 days to assure full availability of this next-generation technology.”

The Endeavor clinical programme includes seven studies: three randomised 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 who were studied to two years and 675 to three years. Highlights from the programme include the following results:

Presented at the FDA panel meeting in October 2007, an analysis of pooled safety data from the Endeavor clinical programme reported a Stent thrombosis rate for Endeavor patients of less than one 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.

The Endeavor Stent offers clinical effectiveness that is consistent with the current market-leading drug-eluting Stent in the USA. Endeavor IV, the randomised 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. Endeavor had similar efficacy compared to Taxus for all lesion subsets analysed, and there were no statistically significant differences in target lesion revascularisation (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 randomised controlled trial requiring a repeat procedure out to three years of follow-up.

Ultimately, the Endeavor clinical programme will enroll more than 22,500 patients followed to five years; approximately 16,630 of these patients will receive an Endeavor stent.

As a condition of FDA approval, Medtronic will continue its extensive post-market clinical programme, which will now add sites in the USA to ensure that at least 5,000 patients are followed to a minimum of five years. In addition, Medtronic will collaborate with the FDA to conduct or participate in a study intended to identify the optimal duration of dual antiplatelet therapy following percutaneous intervention with the Endeavor drug-eluting stent.
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