The FDA's advisory committee has unanimously recommended the Endeavor drug-eluting stent (Medtronic) for conditional approval as a treatment for coronary artery disease. The FDA's Circulatory System Devices Panel voted unanimously to recommend the Endeavor stent for approval with conditions related to product labelling and post-market study requirements.
The advisory committee recommended that the product's labelling 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 Medtronic's proposal for a post-market study.
The Endeavor drug-eluting stent (DES) is made of a cobalt alloy and is built on the same platform as Medtronic's Driver bare metal stent (BMS), 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.
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 Endeavor drug-eluting stent significantly reduces restenosis and the need for repeat procedures while maintaining an excellent long-term safety profile," according to Dr Martin B Leon, Columbia University Medical Center, NY, and principal investigator of the ENDEAVOR III and ENDEAVOR IV Clinical Trials. "Importantly, rates of cardiac death, myocardial infarction and stent thrombosis are exceptionally low with the Endeavor stent out to three years of patient follow-up."
Highlights from the clinical studies of the Endeavor stent include the following findings:
Endeavor reduced restenosis in patients by more than 60% over its BMS comparator, Medtronic's Driver BMS, at nine months.
The reduction in restenosis is sustained over time as Endeavor showed a 92.8% freedom from Target Lesion Revascularization (TLR) at three years, meaning less than 8.0% 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% of Endeavor clinical patients have survived without a cardiac death beyond three years after implant; 97.3% of the Endeavor clinical patients have been free from MI at three years.
There is no evidence of increased stent thrombosis risk within one year (0.7% Endeavor vs. 1.3% Driver per ARC definite/probable) or in years one to three (0.1% Endeavor vs. 0.2% Driver) in patients treated with the Endeavor stent compared with those treated with the Driver BMS.
In the ENDEAVOR IV clinical trial at nine months, the overall stent thrombosis rate was 0.8% (protocol defined), and there were no stent thrombosis observed after six months.
"We are very pleased with the outcome of today's panel meeting and appreciate the advisory committee's careful consideration of the extensive data on the Endeavor stent," said Scott Ward, president of Medtronic's CardioVascular business. "We will continue to work with the FDA to bring the Endeavor stent to the US market as soon as possible so that patients and physicians in the US can benefit from this next-generation technology. We believe that Endeavor provides the optimal combination of safety, efficacy and deliverability."
The recommendation would mean that the Endeavor stent would become the first new DES to be introduced in the US since 2004. The device is limited by federal (US) law to investigational use only.
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