Heart device approval delays leave US doctors frustrated
NEW YORK (REUTERS) - Americans accustomed to immediate access to the newest technology may be shocked to find that is not the case when it comes to devices that treat ailing hearts.
United States approval requirements for cardiac devices are much more stringent than in Europe, where there is no centralised decision-making body. But a growing number of US heart doctors feel the regulations are so demanding that patients are being denied access to beneficial therapies.
From 2006 to 2011, European regulators approved mid-to-high-risk medical devices, including heart devices, an average of four years ahead of the more conservative US Food and Drug Administration, according to a report last year by Boston Consulting Group (BCG).
The quicker road to market in Europe did not lead to a discernible increase in recalls or safety problems, according to BCG and the California Healthcare Institute, which conducted the study, and Eucomed, the European trade group.