This Device Won FDA Approval 11 Years Ago This Week

This week marks an important anniversary in medtech: The 11th anniversary of transcatheter aortic valve replacement (TAVR) being approved by FDA.

The agency announced on November 2, 2011 that it had approved Edwards Lifesciences' first-generation Sapien TAVR device for patients with severe aortic stenosis who are ineligible for open-heart surgery. The decision was supported by the results of the PARTNER (Placement of AoRTic TraNscathetER valve) trial published in 2010, showing that TAVR using the Sapien device reduced all-cause mortality and repeat hospitalization compared with standard therapy, although the risk of stroke and vascular complications was higher. The device is made of cow tissue and polyester supported with a stainless-steel mesh frame.

What really stands out when we revisit this part of medtech history, however, is that it highlighted an undeniable lag between medical devices entering the market in Europe versus the United States. By the time FDA approved the first TAVR device, Edwards' Sapien valve had already been on the market in 40 countries, including most of Europe. In fact, Edwards had already brought its second-generation TAVR device, the Sapien XT, to the European market via a CE mark in 2010. Medtronic also had a TAVR device on the market in Europe at the time, but FDA didn't approve the CoreValve TAVR device until January 2014.

From 2003 to 2007, FDA's premarket approval (PMA) pathway took an average of 15.5 months, MD+DI reported in 2011, citing data from Ernst & Young. In 2010, it took nearly double that — 27.1 months.

In 2010, a report made the rounds in the industry with support from the Medical Device Manufacturers Association and others, titled, "FDA Impact on U.S. Medical Technology Innovation." The report compared PMA and the European CE mark numbers in 2009, based on a survey of 200 medtech companies. For companies clearing products in Europe, it took an average of 11 months from first communication to certificate. To bring a market through the PMA process, however, companies had to wait 54 months, on average, from the first communication to final FDA approval.

The regulatory tide has certainly changed over the past decade, however. FDA has made significant progress toward addressing its approval times, first with the expedited access pathway, which served as a precursor to the agency's current breakthrough device designation program.

At the same time, the new medical device regulation (MDR) in Europe has made it much more time consuming to get a CE mark, which is perhaps the biggest driver to flipping the trend between approval times in the United States versus Europe. Many medical device manufacturers have said that pursuing regulatory approval in Europe first has lost its appeal. Some critics of the new regulations have gone as far as to say that the MDR is hurting innovation in Europe. 

Check back next week for a new Trivia Tuesday question on our home page and test your knowledge about the medical device and diagnostics industry!