European experts have criticised a new heart valve procedure as "risky and costly".
The Belgian experts blame a loophole in European laws for the rapid introduction of transcatheter aortic valve implantation on the continent.
The procedure was designed for people who are too frail for open heart surgery.
Around 40,000 of the operations have been performed in the last decade although British regulators – at the National Institute for Health and Clinical Excellence – say evidence backing it is "inadequate".
And writing in the British Medical Journal today, Hans Van Brabandt from the Belgian Health Care Knowledge Centre says: "The arguments supporting the widespread use of TAVI do not stand up to scrutiny."
The researchers say the procedure was introduced in Europe four years before the USA because TAVI was classed as a device and manufacturers were not required to produce evidence of clinical testing.
They say Europe "should require high quality randomised trials to show clinical efficacy and safety before granting marketing approval to innovative, high risk medical devices."
A second report today in the journal PLoS Medicine backs the calls for tougher regulation of medical devices in Europe
Researcher Daniel Kramer from Harvard Medical School in Boston, USA, writes: “Few studies have quantitatively assessed medical device regulation in either the US or EU.
"Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU."
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