In Charles Dickens? novel A Tale of Two Cities, the dejected Sydney Carton takes the place of his doppelganger, Charles Darnay, at the guillotine during the throws of the French Revolution. Perhaps a similar story is unfolding now with two technological brothers: transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair. And like the literary pair, the fate of these devices is particularly different in France.
These devices gained CE mark approval around the same time and aim to treat elderly patients with cardiac diseases who are too frail for surgery. Abbott's MitraClip uses a percutaneous technique to treat mitral valve regurgitation and TAVR is curative for aortic valve stenosis. Unsurprisingly, these products are more expensive than their surgical counterparts.
But their life stories, like those of Carton and Darnay, are quite different. TAVR has been a huge success, generating hundreds of millions of dollars in sales around the world and is largely responsible for lifting Edwards Lifesciences? stock price by 600% since 2008. With no need to open the chest, there is no lengthy recovery after a TAVR procedure, leading patients to demand it if they are candidates for surgery.
MitraClip has not seen the same runaway success. Physicians reluctantly use it with frail patients, knowing that the procedure precludes any kind of future intervention. Mitral valve regurgitation is a more thorny indication, with grades of severity and complicated physiology, making assessing the benefit of any treatment difficult to assess. Aortic stenosis makes physicians seem like heroes: replacement is the only treatment, done in a simpler anatomy, and yields a rapid and significant improvement in health.
France has once again proven to be a theatre of fate: the High Health Authority has made reimbursement for TAVR reliable and will be increasing the procedure threshold later this year, adding a boost to sales growth different than the rest of Europe. MitraClip, on the other hand, has been under health economic review for the past year with no clear sign on if the Authority will give an iota of assent to its use.
It really is the best of times and the worst of times.