Valentine's Day is a time when we all reflect upon our romantic and personal relationships. In Medtech, we also like to take this opportunity to think about some noteworthy and challenging relationships between the FDA and novel devices in the industry. Like the rest of us, things have not always been smooth-sailing between the two. But, with the FDA's accelerated approval process, it's possible that a happy ending for these relationships is not far away. In the meantime, here's a list of heart-pounding cardiovascular devices that finally captured the FDA's heart!
Foam sclerotherapy is a procedure that has been around for over 100 years to treat varicose veins and is widely used in Europe. In the US however, foam sclerotherapy remained an off-label treatment until last year. After finally receiving an FDA approval in November 2013, Varithena has become the first and only commercially available foam sclerotherapy device in the US.
WATCHMAN LAA closure device
The FDA has had a long and tumultuous relationship with LAA closure devices which goes as far back as 2009. After some dramatic events involving several panel votes, trials and leaked results, the WATCHMAN LAA closure device is finally expected to receive FDA approval within the next few months, with panel voting in favour of approval in December 2013.
Now this is one love story for the books! Earlier in 2014, this transcatheter heart valve (THV) obtained an early FDA approval without an independent panel review based on exceptional clinical outcomes. CoreValve joins SAPIEN as the only transcatheter aortic valve replacement device currently with FDA approval. As a minimally invasive alternative to open heart surgery, THVs are the latest innovations in the heart valve device market.
So, if Valentine's Day sometimes brings you down, fear not! As we've learned from the Medtech industry, there is hope that you too can one day have a successful, heart-pounding and head-over-heels relationship.