Healthcare Industry News: STENT Thrombosis
News Release - October 5, 2007
Medtronic to Present Findings from the Comprehensive ENDEAVOR Clinical Experience to FDA Advisory Panel
Volume and duration of safety and efficacy data sets new standard for DES submissions2,100 Endeavor patients studied in four clinical trials; 1,287 patients studied to 2 years; 675 patients studied to 3 years
Combined safety and efficacy performance unique among drug-eluting stent platforms
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) 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 ). 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.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Caution: The Endeavor(TM) 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 Medtronic's Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
Source: Medtronic
Issuer of this News Release is solely responsible for its
content.
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