DES From Abbott Outperforms Market-Leading Stent
Long term data presented for the first time recently from the Spirit III trial,
Abbott's US pivotal trial studying the XienceTM V Everolimus Eluting Coronary
Stent System, demonstrated that Xience V continues to deliver clinically
superior benefits for patients compared to the Taxus® paclitaxel-eluting
coronary stent system. In this trail of more than 1,000 patients, Xience V
demonstrated a 45 per cent reduction in the risk of major adverse cardiac events
(MACE) and a 32 percent reduction in the risk of target vessel failure (cardiac
events related to the treated vessel) at two years as compared to Taxus. The
Spirit III two-year results were presented by Gregg W Stone, Principal
Investigator of the Spirit III trial, during the late breaking clinical trials
session at EuroPCR 2008.
"Not only did Xience V clearly differentiate itself from the Taxus stent in the
first year after treatment, it has now demonstrated even more positive effects
at two years in the SPIRIT III trial," said Dr. Stone, Columbia University
Medical Center and Chairman, Cardiovascular Research Foundation, New York. "As
measured by clinically significant reductions in target vessel failure and MACE,
Xience V demonstrated an even greater improvement in patient outcomes compared
to Taxus at two years than at one year, driven by numerically lower rates of
heart attacks and lower observed rates of re-intervention of the target lesion.
We also saw encouraging trends for lower observed rates of late and very late
stent thrombosis in Xience V-treated patients, especially in those who
discontinued dual antiplatelet therapy."
The Spirit III trial of 1,002 patients, which is the basis for the pre-market
application of Xience V to the US FDA, demonstrated the key results for Xience V
at two years.
The results showed a 45 percent reduction in the risk of major adverse cardiac
events (MACE) compared to Taxus (7.3 percent for Xience V vs. 12.8 percent for
Taxus, p-value=0.004)-. MACE is an important composite clinical measure of
safety and efficacy outcomes for patients, defined as cardiac death, heart
attack (MI), or ischemia-driven target lesion revascularization (TLR driven by
lack of blood supply).
It also demonstrated that a 32 percent reduction in the risk of Target Vessel
Failure (TVF, cardiac events related to the treated vessel) compared to Taxus
(10.7 percent for Xience V vs. 15.4 percent for Taxus, p-value=0.04). TVF is a
composite clinical measure of safety and efficacy outcomes defined as cardiac
death, heart attack (myocardial infarction or MI) or target vessel
(Ref: The Modern Medicare June 2008)
FDA Claims To Approve Medical Devices Faster
In a new
report, the agency maintains it is now faster at approving applications than in
In fiscal 2006 the FDA, on average, took 335 days to
approve the devices, which range from X-ray machines to syringes, compared with
438 days in 2005.
But approval of devices under a separate,
abbreviated "510K" application process required, on average, 95 days in 2006,
compared with 87 days in 2005. Nonetheless, the FDA argues "the average review
time from receipt to final decision has declined" since Congress passed a law
overhauling device regulations in 2002. Approval data for fiscal 2007, which
ended last Sept. 30, was not yet available.
the changes in part to help streamline the review process and review time goals.
The 2002 law also allowed the FDA to levy fees on device makers to help pay for
the review process. As part of the changes, the FDA also set up third-party
programs that allow independent companies to review applications before the
agency makes the final decision.
While the report did not give
specific 2007 data, there were 16 percent fewer, or 233, third-party reviewed
applications submitted compared with 278 in 2006, however, that was before
Congress amended the program last year to ease some restrictions. Critics of the
third-party review program say the FDA should get more funding to do the reviews
Overall, the FDA said it cleared 2,640 devices for use
under its so-called "510K" process in 2007 compared with 2,677 devices in fiscal
year 2006. Device makers using the abbreviated "510K" process only need to show
the agency their product is as good as similar ones on the market, Reuters
notes. For new types of devices, manufacturers must file a premarket approval
application with more data to show the product is safe and effective, Reuters
By Ed Silverman // June 23rd, 2008, Source: Reuters