Article preview from IN VIVO - September, 2012
Given the competing interests and different challenges – balancing internal R&D with external M&A, managing rival customer groups, and tackling a tough regulatory path to name just three – Edwards Lifesciences’ success in TAVI may be even more impressive than it looks. IN VIVO interviews CEO Mike Mussallem about how Edwards developed TAVI and the obstacles and challenges the company faced along the way.
Edwards’ High Wire Act In TAVI: An Interview With Mike Mussallem
A dozen years ago, when Edwards Lifesciences Corp. spun out of Baxter International Inc. as a separate publicly traded company, few cardiovascular device executives took seriously the notion that Edwards might one day challenge the group of huge, dynamic cardiovascular giants for pre-eminence in the industry. Most of the giants, after all, were pursuing ambitious technologies, like drug-eluting stents, in the fast-growing interventional cardiology market. Edwards, for its part, was content to inhabit a much smaller, less dynamic niche, focusing on later-stage patients and mostly surgical cases, with a strategy that seemed specifically to steer the company far afield from interventional cardiology, relying instead on technologies that while clinically valuable had little of the envelope-pushing intensity of interventional cardiology.
How much has the world changed since Edwards’ early days as a newly public company. The competitive landscape has almost entirely been redrawn, with one-time market leaders like Guidant no longer around, while companies such as Boston Scientific Corp. have struggled and Cordis Corp. (a Johnson & Johnson subsidiary) recently announced its departure from coronary stents, a market it once dominated. Most striking of all, few industry executives today would deny Edwards its place at or near the top of the cardiovascular device industry, largely as a result of one of the most dynamic technologies to emerge in recent years – transcatheter valves – and an interventional technology at that.
Even five years ago, Edwards was, at best, a small presence at leading interventional conferences such as TCT and PCR. Today, on both the clinical stage and exhibit floor, Edwards is a major presence. More to the point, for those who’ve watched Edwards’ trajectory, the company’s rise has arguably been even more impressive than it is on face value. It’s axiomatic in business circles that companies with large stakes in valuable franchises find it difficult to embrace technology that threatens those franchises. But Edwards early on began to develop a transcatheter approach to aortic valve replacement that at once was greeted skeptically by both interventionalists and surgeons, threatened its core franchise, promised to alienate its core customer group, faced enormous clinical and technology challenges, required the merger of internal R&D teams and an external acquisition, and ran head-on into the growing regulatory turmoil the device industry has faced.
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