Quoting Motley Fool's Article "The Expectations Hangover Still Hurting Edwards Lifesciences":
1) While the stock was in the $90s, I dutifully played my role of Cassandra -- pointing out that analysts and investors were getting carried away with their expectations for the adoption of transcatheter heart valves and underestimating the risks of competition from companies like Medtronic
2) As it turns out, a lot of those fears were well-founded. Sales in the U.S. have disappointed for four straight quarters now, and the shares have been cut down by near 40%.
3) I also believe that Edwards has likely put too many eggs in this basket and under-invested in other parts of the business. With less initial enthusiasm for transcatheter aortic valve replacement, or TAVR, in the U.S. than expected and more competitive risk from Medtronic, St. Jude Medical (NYSE: STJ ) , and Boston Scientific (NYSE: BSX ) than the bulls wanted to acknowledge, Edwards is still looking at a rough couple of years for growth and expectations.
4) it's going to take quite a bit more time and data to drive adoption there.
5) What has been harder to prove, though, is the economic benefits to the procedure. While TAVR with the Sapien family of valves does result in shorter hospital stays, they're not as short as initially advertised, and that compromises the argument. In addition, the outcomes of TAVR appear to be highly experience-dependent, which means that many hospitals have taken a "go slow" approach with their initial cases.
6) some believe the CoreValve is easier to deliver and deploy and there is little question that Medtronic has a formidable sales force to back up its efforts. Although Edwards has secured an injunction against Medtronic marketing the CoreValve in Germany due to patent infringement, it's unclear if Edwards will succeed in other markets, including the U.S.
7) I still don't think Edwards is quite cheap enough yet to make it a top-tier idea for new money.
8)Edwards is likely to be facing solid clinical data from Medtronic at TCT this year (and ACC next year), not to mention successive updates and progress to marketing approval from St. Jude and Boston Scientific.