BARCELONA, Spain — Mike Mussallem, CEO of Edwards Lifesciences (Irvine, California), was clearly having a good showing at EuroPCR 2009, dashing between the company stand previewing new products and conference sessions presenting results from years of clinical studies that confirmed the safety and efficacy of the current Sapien heart valve.

"We sold $50 million Sapien valves in 2008 and we are going to do more than $100 million this year," Mussallem told Medical Device Daily. "This is all upside for us," he enthused.

"People say there is no reward for innovation until you get to the United States, but the rapid acceptance of our products here in Europe shows a different story, and Europe is becoming a bigger piece of the Edwards pie," he said.

Even as Edwards celebrated its go-to-market success and sales after seven years of research and development since the first-in-man implantation, just a few meters away a new and formidable competitor was taking shape.

Medtronic (Minneapolis) acquired CoreValve (San Diego) a few weeks ahead of EuroPCR and at its booth a simple logo and a crowded, closed demonstration booth were the only evidence in the exhibition area of the dynamic CoreValve that last year rivaled Edwards for booth size and product demonstrations.

Meanwhile Edwards is celebrating 50 years in heart valves this year, having co-developed the first-in-human device implanted in Boston in 1960, as well as the first valve implanted using a transcatheter delivery in 2002 in Rouen, France.

Yet being the original and the most experienced in any field is not enough to assure success today and the triumph of Edwards was quickly matched in conference sessions with presentations of 12-month results for the CoreValve Revalving System.

Jockeying for product features

Edwards' Sapien is predominantly implanted using a transapical approach where the catheter is inserted between the ribs in a procedure familiar for cardiac surgeons, CoreValve offers an expandable valve that is implanted predominantly using a transfemoral approach more familiar to cardiac interventionalists.

With a more supple valve and a thinner delivery system, CoreValve can offer multiple ports of entry and at EuroPCR presented results for access through the subclavian artery for patients with compromised femoral arteries, the 25% of patients who typically undergo the transapical procedure.

Edwards responded to this challenge into its territory with the presentation at EuroPCR of the first-in-man (FIM) implantations of its next-generation Sapien XT valve using a fourth-generation, thinner NoveFlex delivery system.

The Sapien XT, an aortic valve with a cobalt chromium alloy balloon-expandable frame, is currently under evaluation in the PREVAIL EU trial for CE-mark approval, which is expected in 2010, according to Patrick Verguet, vice president for Europe with Edwards.

Taken together, the new valve and the 18 Fr NovaFlex delivery system are more friendly for transfemoral artery delivery by interventional cardiologists than current Edwards products, he said.

"Edwards has been making valves for 50 years, this is not new to us, nor are the surgeons. It is the delivery system that is new," Verguet said.

Facing off with a muscular adversary

Following on the CoreValve acquisition that gave it a valve and a delivery system, Medtronic intensified the competition in delivery systems with the $325 million acquisition of Ventor Technologies (Netanya, Israel) in late February, adding surgical transapical technology to its portfolio.

Ventor also is developing what Medtronic called a next-generation transfemoral technology furthering Medtronic's strategy to offer "compelling clinical benefit to distinctly different subsets of patients treated by both surgeons and interventional cardiologists," according to Dan Beach, director of communications for the CardioVascular unit of Medtronic.

"When Medtronic acquired CoreValve and Ventor, we already had a device under development with a team of 60 engineers," said Beach.

"Combining this platform with the engineers and expertise at CoreValve and Ventor will create a powerful internal development capability," he said.

"On top of this there are the manufacturing and distribution strengths of Medtronic, as well as a very strong medical education experience," Beach added.

"Edwards is great on transapical, but in transfemoral they have already lost that battle since we account for 75% of that market," he told MDD.

Beach said Medtronic believes TAVI will be adopted as a standard of care within the next five years and looking 10 years out, TAVI will develop into a market the company estimates to be between $2.7 billion and $3.5 billion.

In a discussion with analysts on the eve of EuroPCR, Medtronic Chairman/CEO Bill Hawkins said, "This is clearly an exciting opportunity and is already a market that is taking off in Europe and based on the excitement that I heard from physicians it should be an even more compelling opportunity ... in the U.S."

Still, for Hawkins, the cardiovascular division is just $2.5 billion of Medtronic's $14.6 billion annual revenue and he called the combined take-over of CoreValve and Ventor "tuck-in acquisitions" that are part of a larger strategy.

Leveling the playing field

At Edwards, Michelle McAdam, vice president for global communications, does not dispute the overview from her colleague Beach at Medtronic.

"We estimate the two companies each own roughly half of the total transcatheter market," she told MDD.

"Currently, two-thirds of our sales are transapical and a third transfemoral, but Edwards owns 100% of the transapical market," she added.

Saying Edwards owns roughly 25% of the transfemoral market currently, she said there will be a dynamic change in the market when Edwards commercially launches the Sapien XT and NovaFlex delivery system (smaller 18 French size).

"We expect this will level the playing field," she said, acknowledging that "Up until now, we have been at a competitive disadvantage with our larger size delivery system as it limits the number of patients that can receive the Edwards device transfemorally."

Yet with $1.24 billion in sales in 2008, Edwards may begin to look like a nice "tuck-in" opportunity for someone else's strategy.

Asked how long he expected to stay independent, European VP Verguet told MDD ambiguously, "as long as possible."