Abbott's Bioresorbable Stent: Another Case of Innovation vs. FDA

Posted by Shana Leonard on October 19, 2011

Abbott Laboratories claimed the top honor in the medical devices category of the Wall Street Journal's Innovation Awards this week with its highly anticipated bioresorbable vascular scaffold dubbed the Absorb. But this accolade for innovation inadvertently draws attention to a much larger debate currently dominating the medical device industry with just one sentence in the WSJ: "The company received approval this year to launch the stent in Europe and is aiming to get U.S. Food and Drug Administration approval in 2015."

Abbott Absorb
Image: Abbott Labs

The company announced the proposed FDA submission date when it promoted clearance for the product in Europe back in January. But the anticipated FDA clearance date of 2015 seems to stand out much more prominently in the context of an innovation award. After all, the Absorb bioresorbable stent has garnered a great deal of attention and hype because it represents what many herald as the future of stent design. The catch is that, for Europe, the future of stent design is now. Or, is closely at hand in a full-scale launch in 2012, at least.

Of course, this disparity in approval timeframes between the United States and Europe is nothing new nor is it shocking. But the expected domestic approval lag of the Absorb does seem to exemplify some of the mounting complaints and concerns from the medical device industry. Because of FDA's stringent requirements and lengthy approval process, will the United States fall behind in terms of innovation? If the medical device is good enough for use in the regulated EU, why isn't it good enough for the United States?

Criticism of FDA appears to be reaching a fever pitch as VCs take their complaints to Capitol Hill and pundits become increasingly vocal of the agency's rigorous processes and alleged inefficiencies. An impassioned opinion piece that appeared in the WSJ a few weeks ago, titled "How the FDA Could Cost You Your Life," detailed a procedure cleared in Europe four years ago that has just been approved for use domestically. The author asserts that this lag time was to blame for many preventable deaths that could have ben avoided in the meantime through the use of this method. Likewise, the Absorb could allow for patients to avoid risky explantation surgeries, but will not do so in the United States for another few years. While ensuring the safety and efficacy of a device is, of course, paramount, getting innovative product designs such as the Absorb stent to market is important, too.

For more information about stent design, check out the recent feature, "Shrinking Stents Strut Their Stuff." --Shana Leonard