By Stewart Eisenhart, Emergo Group
March 24, 2014 by Arezu Sarvestani
The European Commission asked a scientific advisory panel to look into the safety of surgical procedures to treat urogynecological conditions using mesh products, which have embroiled their makers in tens of thousands of product liability lawsuits in the U.S.
The EU’s executive body asked its Scientific Committee on Emerging and Newly Identified Health Risks for an opinion on the "safety of surgical meshes used in urogynecological surgery," according to the commission’s request.
The ReBioStent project, led by U.K.-based Ceram, landed a $8 million (€5.8 million) grant to put towards developing new biomaterials and new arterial stents.
The ReBioStent project is seeking to develop biodegradable and biocompatible medical products, including stents. The 3-year project began this year and currently has 14 academy and industry partners working on it, according to a press release.
A European Parliament panel yesterday OK’d more stringent oversight of medical devices in the European Union that would require clinical trials for implants and other Class III devices across the pond.*
If enacted, the new regulations would require implants like heart pumps or joint replacements to undergo a process much more like the FDA’s pre-market approval protocol in the U.S., under the purview of the European Medicines Agency.
A key market for the medical device industry showed some strong signs of life today, following sobering economic news out of Europe yesterday.
Japan, the world’s 3rd-largest economy and 2nd-largest medical device market, reported that its gross domestic product grew at an annualized rate of 3.5% during the 1st quarter and is up 0.9% from the previous quarter. Analysts had predicted a 2.8% annualized growth rate and 0.7% growth for the quarter.