Medtronic Learns From Edwards Lifesciences' Errors in TAVR Launch

Medtronic is launching its CoreValve transcatheter aortic valve replacement device roughly two years behind Edwards' Sapien device. What will it do differently?


The CoreValve Transcatheter Aortic Valve Replacement System from Medtronic


Roughly two years ago a Medtronic executive declared publicly that he was rooting for rival Edwards Lifesciences to succeed with its innovative transcatheter aortic valve replacement device.

Transcatheter aortic valve replacement has been considered one of the more clinically exciting, minimally-invasive technologies in treating patients with diseased heart valves who can’t or won’t endure open-heart surgery. Edwards won FDA approval for its Sapien TAVR device in November 2011, giving it more than two years in the marketplace in the U.S. with the only approved TAVR device. Medtronic won approval for its competing, CoreValve device in January.

It appears that Medtronic is taking its second-mover disadvantage to be a way to learn from Edwards’ mistakes in its TAVR launch and sales ramp. And avoid them altogether.

In its fiscal-third quarter earnings call Tuesday, Mike Coyle, president of Medtronic’s Cardiac and Vascular group said that the company plans to train 20 to 40 medical centers to use the CoreValve Transcatheter Aortic Valve Replacement system in the next two quarters. And then training will ramp 40 centers per quarter.

In other words in the first 12 months, Medtronic expects to train 120 medical centers on the low end and 160 on the top.

Compare that to how Edwards CEO Michael Mussallem answered the question about TAVR ramp back in April 2012, the first full quarter after Sapien launched.

“Since the November launch, we’ve trained approximately 60 centers. Reimbursement uncertainty has caused some centers to postpone their training and others to delay procedures. However, physician and hospital interest in our SAPIEN program remains very high, and we still expect to train 150-250 new commercial sites in the first 12 months.”

Medtronic’s high-end number in training centers is only 10 more than Edwards’s lower end projection. They seem to be adopting a more conservative approach.

One year later from Mussallem’s initial enthusiasm about how many medical centers would be trained, he was lowering expectations in an earnings call. He was forced to admit that 20 medical centers that were due to be trained in TAVR transapical procedure postponed the training. He added a total of 225 centers had been trained since launch, out of which 180 had been trained in the transapical approach. 

While the overall annual goal of training 150-250 medical centers was met, TAVR sales projections fell short. First-quarter 2013 sales came in at $83 million, which was $7 million less than what Wall Street analysts were expecting. In fact, Edwards has had to adjust expectations in successive quarters throughout last year. That's one major reason why Edwards' landed in MD+DI’s 2013 Losers list.

Only time will tell how well Medtronic’s CoreValve will fare in the marketplace. But looks like for now Medtronic has decided their guiding mantra for TAVR launch will be that age-old adage that says 'fools rush in where angels fear to tread.'

 -- By Arundhati Parmar, Senior Editor, MD+DI

 UPDATE: The article has been modified to reflect additional information regarding how many centers Edwards trained using the transapical approach as described in its Q1 earnings call.

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