SAN FRANCISCO – Edwards Lifesciences Corp. said it's doubling down on a plan to be successful in the transcatheter mitral valve replacement (TMVR) market. The Irvine, Calif.-based company laid out what said is its 'shots on goal' strategy to penetrate the TMVR space, during the 35th annual J.P. Morgan Healthcare Conference.

The increased focus on TMVR has been dubbed by some analysts as the 'second act' for Edwards, which has already established a leading position in the transcatheter aortic valve replacement (TAVR) space.

"It will be Edwards' progress in mitral and transcuspid therapy that gives investors a view into what could be a double-digit top line grower through 2025," said Michael Weinstein, an analyst with J.P. Morgan.

Raj Denhoy, an equity analyst with Jefferies said that TAVR growth would eventually slow, but the mitral space provides plenty of growth opportunities for the company.

Edwards has spent the last few years acquiring technologies for TMVR therapy. Most recently, the valve specialist made an emphatic statement in the TMVR market when it said it would acquire Or Yehuda, Israel-based Valtech Cardio Ltd. for $340 million, with the potential for $350 million in additional milestone payments. (See Medical Device Daily, Nov. 29, 2016.) Valtech Cardio had been courted for acquisition before by Medtronic plc's Heartware International Inc. (See Medical Device Daily, Jan. 29, 2016.)

With Valtech, Edwards gains access to Cardioband, a transcatheter ring technology and sets the company firmly against Abbott Park, Ill.-based Abbott Laboratories' Mitraclip device.

In other Mitral valve news, Edwards said the first patients have already been treated with its new Pascal TMVR system and that plans are underway to initiate a CE mark study this year. In addition, Edwards said it will highlight the early patient experience treating tricuspid regurgitation with its Forma tricuspid spacer and expects a CE mark for that product in 2018.

"We have this high risk, high return opportunity [in TMVR] and we have to humbly say, we're not sure what kind of therapy is going to be the most safest and most durable," Michael Mussallem, Edward's chairman and CEO told the audience. "We've got a lot to learn on that. In that spirit, we're applying a little bit of a shots-on-goal mentality to take on the most promising of those technologies."

Edwards isn't the only company innovating in the TMVR space.

The TMVR market has been heating up over the past few years. In July 2015, Abbott Laboratories reported plans to pay $225 million for the equity of Roseville, Minn.-based Tendyne Holdings Inc. that it did not already own at the time, making the total deal worth $250 million plus potential regulatory-based milestone payments. The company closed on that deal in September 2015. (See Medical Device Daily, July 31, 2015.)

In a separate deal, Abbott said it had invested in mitral valve repair company Cephea Valve Technologies Inc., of Santa Cruz, Calif., with an option to buy.

In late August, Dublin-based Medtronic plc jumped into the TMVR pool and agreed to pay up to $458 million to acquire Redwood City, Calif.-based Twelve Inc. (See Medical Device Daily, Aug. 26, 2015.)

NOT DONE WITH TAVR BY A LONG SHOT

While TMVR presents a strong opportunity for Edwards, Mussallem pointed out that the company has "barely scratched the surface" of TAVR. Edwards is the noted pioneer in the space, having secured FDA approval for its Sapien valve back in 2011. (See Medical Device Daily, Nov. 4, 2011.) So far, Edwards' only rival in the U.S. TAVR market is Medtronic's Corevalve technology.

One of the company's bold moves into the space will be to look for an indication that will see its TAVR devices treating asymptomatic patients with severe aortic stenosis (AS). Historically, management of asymptomatic patients with severe AS has been challenging for the medical community. Many of the patients are asymptomatic for years despite having high velocity through the valve. In addition, about half of patients with severe AS report no symptoms at the time of diagnosis.

The company is addressing these patients through its EARLY TAVR trial, which is still pending FDA submission and approval.

Such an approval would be a huge coup for the company. The firm said there could be an initiation of the EARLY-TAVR trial sometime this year.

The company also said it expects a CE mark for two TAVR devices, the Sapien 3 Ultra System and the Edwards Centera Valve System, in the second half of next year.

"We like to lead," Mussallem said. "We like to go first. It sounds easy, but it's not without a certain degree of concern. But what you do is put yourself in a position to learn fast and to learn the most."