MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE:MDT - News) announced today a synopsis of clinical data on the Endeavor(TM) Drug Eluting Coronary Stent to be presented to an FDA Advisory Panel on October 10. This announcement was made in conjunction with the release of FDA Advisory Panel materials by the U.S. Food and Drug Administration 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 Advisory Panel will consider whether to recommend approval of the device to the FDA. The Panel's recommendation will be subject to FDA approval.

"The Endeavor clinical program has compiled a comprehensive set of data on the safety, efficacy and procedural success of the next-generation Endeavor stent," said Scott Ward, president of Medtronic's CardioVascular business. "The volume and duration of the Endeavor clinical data is unmatched by any previous DES submission and the most extensive ever considered by an FDA Advisory Panel for approval. The performance of the Endeavor stent has been well characterized across different time frames, patients and geographies, which should facilitate the Panel's review."

Medtronic will present the FDA Advisory Panel data from the ENDEAVOR I - IV clinical trials, which are designed to illustrate the consistent treatment effect of the Endeavor stent on key efficacy, safety and procedural success metrics. Highlights are as follows:

-- 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 bare metal
        stent, at nine months.

    -- The reduction in restenosis is sustained over time as Endeavor
        shows 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
        revascularization.

-- A unique, long-term safety profile has been established on the
    Endeavor stent.

    -- Low rates of cardiac death, myocardial infarction (MI) and
        stent thrombosis are confirmed 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% vs. 1.3% ARC definite/probable) or in years one
        to three (0.1% vs. 0.2%) in patients treated with the Endeavor
        stent compared with those treated with the Driver bare metal
        stent.

    -- Using the protocol specified definitions of stent thrombosis,
        the Endeavor program has no stent thrombosis beyond six months
        in its clinical program (EI-EIV).

"The Endeavor stent has shown tremendous consistency and balance across the major study endpoints addressing efficacy, safety and deliverability," said Martin B. Leon, M.D., Columbia University Hospital, N.Y., and principal investigator of the ENDEAVOR III and ENDEAVOR IV clinical trials. "Endeavor's performance on safety is particularly noteworthy, and the clinical program to date is sufficient - in regards to number of patients and duration of follow up - to conclude that Endeavor has an excellent safety profile. Patients in the Endeavor clinical program have been well served by receiving this next-generation technology."

Today's announcement also included newly released information on the successful outcome of the ENDEAVOR IV clinical trial. The ENDEAVOR IV clinical trial is a randomized, single-blind trial evaluating the efficacy and safety of the Endeavor stent as compared to the Taxus Paclitaxel-Eluting Stent from Boston Scientific Corporation (NYSE:BSX - News). ENDEAVOR IV is evaluating 1,548 patients at 80 clinical centers in the United States with a primary endpoint of Target Vessel Failure (TVF) at nine months. TVF is a composite endpoint which includes cardiac death, MI, and Target Vessel Revascularization (TVR).

As previously announced by Medtronic, the Endeavor stent met the ENDEAVOR IV trial's primary endpoint and demonstrated comparable (non-inferior) composite clinical outcomes to the Taxus stent. Endeavor's TVF at nine months in the trial was 6.8 percent versus 7.4 percent for Taxus, with Endeavor demonstrating non-inferiority on all of the key TVF metrics - cardiac death, MI and TVR. In addition, Endeavor's efficacy, as measured by TLR, was 4.2 percent in the trial, statistically equivalent to the Taxus stent (TLR of 2.7 percent) overall and with more complex patient subsets, including diabetics, which comprised 31 percent of patients enrolled in the trial.

Endeavor's unique safety profile was reaffirmed in the trial. Endeavor's overall stent thrombosis rate was 0.8 percent in the trial and no stent thrombosis was observed after six months. Finally, the trial showed a statistically significant difference between Endeavor and Taxus in procedural success as measured by peri-procedural MIs (Non Q-Wave MIs), meaning patients who received Endeavor were less likely to have a heart attack or complication within 30 days of receiving the stent.

"In a large, randomized clinical trial, Endeavor demonstrated efficacy comparable to the U.S. market leader," added Ward. "Endeavor demonstrated strong results on safety, efficacy and deliverability, reinforcing the conclusion that Endeavor offers sound clinical performance."

Medtronic will present the full pre-clinical and clinical experience of the Endeavor stent to an FDA Advisory Panel on October 10.

*** What about the late-loss??? Dare not report because it is very huge and the bad scarring renarrows the artery and reclog up the treated artery. Why measure MACE rate at 30 dys when the trial was 9 months trial???  Because at 9 months MACE rate is probably higher than Taxus. No late-thrombosis after 6 months??? Statistically, late-thrombosis for first generation DES is about 0.5%. Newer DES like Xience and Biomatrix also has no late thrombosis even after 3 years so Endeavor's safety record is no big deal and it is their one and only selling point. In my opinion, this stent performs like Taxus, less late-thrombosis but very bad scarring and artery renarrowing problem. Not a convincing trial result. Medtronic changes conventional DES trial results goal posts and hide ugly facts on other poor performance of Endeavor. Biomatrix still the best. Wait until TCT2007 and see the results. Don't forget Endeavor is now comparing against Taxus Express (older version) and NOBORI 1 phase 2 is comparing against Taxus Liberte (newer and better version).