Anyone who is even slightly aware of the dynamics of the medical device industry knows that Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) are not exactly the best of friends.
The Minnesota behemoth and its smaller California rival have engaged in bitter legal wrangling over intellectual property and patents. Especially with respect to the transcatheter aortic valve implantation (TAVI) technology, Edwards and Medtronic have sued one another.
So it was surprising when Medtronic’s vice president of business development Chad Cornell admitted that he was rooting for Edwards.
“We need Edwards to succeed in transcatheter valve replacement,” Cornell told an audience gathered at the IBF MedTech Investing Conference in Minneapolis on Wednesday. “Success in a market floats all boats.”
Cornell added ominously that if Edwards fails, it will “kill CoreValve.”
CoreValve is the $700 million acquisition that former CEO Bill Hawkins made in 20o9 that brought transcatheter aortic valve implantation technology to Medtronic. The CoreValve system is already approved in Europe and was introduced before Edwards won its CE Mark for the Sapien TAVI system.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In the U.S., the positions are flipped. Edwards is the one who has the lead with the Sapien product getting the regulatory nod in November. Medtronic is currently conducting a pivotal trial to test CoreValve.
The technology is expected to provide a much-needed alternative for patients who have severe narrowing of arteries but for whom open heart surgery to replace the heart valves is too risky.
But doctors have noted that the learning curve to become proficient at TAVI is steep. Not to mention that the editor of an influential journal — Journal of the American College of Cardiology — recognized that the difficulty has exhorted a slow rollout of the system after Sapien received U.S. approval.
How all this will play out over the next year should concern every center and operator contemplating the addition of TAVI to their list of available therapies. [I]t may take more than a full year for an operator to become procedure “proficient,” [and] the question of maintenance of proficiency is totally unanswered at present.
In late April, Edwards reported that while the company remains optimistic about transcatheter heart valves, delay in getting approval for an expanded group of patients is leading it to temper its growth expectations for the rest of the year.
Given this context, it becomes abundantly clear why Cornell wants Edwards to succeed. This is probably one of those rare occasions where being second to market, as Medtronic’s CoreValve will be, is actually a boon. In a sense, the Minnesota device maker will be able to learn from how Edwards navigates the rollout of an exciting new technology that requires a lot of training.
[Photo Credit: David Castillo Dominici]
