Industry News


Industry News
Global Trends
Events Calendar
Web Links

Web Gallery

Advertising  Info



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 revascularisation (TVR).

(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 2002.

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.

Lawmakers enacted 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 itself.

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 adds.

By Ed Silverman // June 23rd, 2008, Source: Reuters

Reference :


Other News

Johnson & Johnson expects growth in hip replacement products, medical devices through 2012
Solvay Advanced Polymers Commissions New PEEK Plant in India
Trivitron JVs with intl cos. to set up India's first Medical Technology Park (MTP)
Medical Devices Made with Tainted Heparin Recalled by Medtronic
Italy-India forum focuses on technology co-operation
Global medical nonwoven disposables market to reach $12 billion by 2010
German firm invests Rs 110 cr in India
Biocon Launches Pre-Filled Safety Syringe
Siemens To Install India's 1st Magnetom Essenza At Aatmajyoti MRI Center
Essel Propack: Acquisition In Medical Devices
Medical Devices, The Next Big Step For Semiconductor Makers





Back | Back To Top | Previous | Next