FDA Advisory Committee Recommends Medtronicâ€™s EndeavorÂ® Drug-Eluting Stent for Approval
Next-Generation DES Represents Promising New Treatment Option for Coronary Artery Disease
MINNEAPOLIS â€“ October 10, 2007 â€“ Medtronic announced today that a U.S. Food and Drug Administration (FDA) advisory committee has unanimously recommended the companyâ€™s EndeavorÂ® drug-eluting stent for conditional approval as a treatment for coronary artery disease. This action positions the Endeavor stent to become the first new drug-eluting stent to be introduced in the United States since 2004.
Meeting today in Gaithersburg, Md., FDAâ€™s Circulatory System Devices Panel voted unanimously to recommend the Endeavor stent for approval with conditions related to product labeling and post-market study requirements. The advisory committee recommended that the productâ€™s labeling reflect the clinical trial protocol use of dual anti-platelet therapy and the available professional society guidelines on their use. The panel also recommended a post-market single-arm registry of at least 5,000 patients 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. This recommendation is consistent with Medtronicâ€™s proposal for a post-market study.
The FDA usually follows the recommendations of its advisory committees.
â€œWe are very pleased with the outcome of todayâ€™s panel meeting and appreciate the advisory committeeâ€™s careful consideration of the extensive data on the Endeavor stent,â€ said Scott Ward, president of Medtronicâ€™s CardioVascular business. â€œWe will continue to work with the FDA to bring the Endeavor stent to the U.S. market as soon as possible so that patients and physicians in the U.S. can benefit from this next-generation technology. We believe that Endeavor provides the optimal combination of safety, efficacy and deliverability.â€
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, Medtronicâ€™s DriverÂ® 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 0.8 percent (protocol defined), and there were no stent thrombosis observed after six months.
â€œThe Endeavor drug-eluting stent significantly reduces restenosis and the need for repeat procedures while maintaining an excellent long-term safety profile,â€ according to Martin B. Leon, Columbia University Medical Center, N.Y., and principal investigator of the ENDEAVOR III and ENDEAVOR IV Clinical Trials.Â â€œImportantly, rates of cardiac death, myocardial infarction and stent thrombosis are exceptionally low with the Endeavor stent out to three years of patient follow-up. The deviceâ€™s consistently strong clinical performance will make the Endeavor stent a welcome addition to the practice of interventional cardiology in the United States.â€
The Endeavor drug-eluting stent is made of a cobalt alloy and is built on the same platform as Medtronicâ€™s popular Driver bare metal stent, which features a unique modular architecture designed to enhance deliverability. In addition to the cytostatic drug zotarolimus (ABT-578), Endeavor is coated with phosphorylcholine (PC) technology, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane. The combination of these components is designed to contribute to an ideal healing response around the stent.
Stents are tiny mesh tubes that prop open previously blocked arteries following an angioplasty procedure. Drug-eluting stents are designed to reduce the rate of restenosis, the reclogging of the stented artery, compared to bare-metal stents.
Medtronic, Inc. (www.medtronic.com), is the global leader in medical technology â€“ alleviating pain, restoring health, and extending life for millions of people around the world.
Caution: The Endeavor Drug Eluting Coronary Stent is an investigational device.
The device is limited by federal (or United States) law to investigational use only.
Any statements made about the anticipated regulatory review or approval are forward-looking statements and subject to risks and uncertainties such as those described in Medtronicâ€™s Annual Report on Form 10-K for the year ended April 27. 2007. Actual results may differ materially from anticipated results.