Edwards Lifesciences Corp. won FDA approval for its Sapien 3 transcatheter heart valve device for aortic and mitral valve-in-valve procedures. The Irvine, Calif.-based company leads the way in a burgeoning sector of the market with the expanded indication. The minimally invasive valve procedure device segment for patients who are not indicated for traditional surgery is expected to grow over the next decade, analysts predict.

"The global transcatheter heart valve replacement and repair [THVR] market was valued at $1.6 billion in 2015 and is expected to expand at a CAGR of 13.9 percent over the forecast period of 2016 to 2026," according a June 2016 Persistence Market Research report on the projected demand to treat aortic stenosis and mitral regurgitation minimally invasively.

Persistence projected the segment to grow quickly in the U.S., reaching a $3.5 billion market by end of 2026. The majority of that growth is expected to be tied to transcatheter aortic valve replacement (TAVR), with 79.9 percent of the market share as compared to TMVR by 2026. Leaders in the segment, along with Edwards, are Medtronic Inc. and Boston Scientific Corp.

Edwards' Sapien device is the first THVR awarded FDA approval for both aortic and mitral valve patients. Heather Bukant, senior manager, global communications at Edwards Lifesciences, told Medical Device Daily, the approval follows a "valve-in-valve FDA approval for Sapien XT in the aortic position in 2015. This latest regulatory approval is a small but important market particularly for those patients with no other options, such as those in need of mitral valve replacement who are deemed high risk for a subsequent open-heart surgery." Prior to the recent approval, Sapien 3 was awarded FDA approval in 2015 for patients with severe symptomatic aortic stenosis, and the following year for patients with intermediate risk with open heart surgery.

AGING AND INCIDENCE

As a large portion of the U.S. population ages, the incidence of aortic stenosis and asymptomatic mitral valve regurgitation is projected to increase. TAVR and TMVR devices also offer an opportunity for those patients who are not candidates for traditional cardiac surgery. Advent of the devices offers a shorter hospital stay and recovery time, but are not without risk, said analysts. Product recalls and poorly positioned devices may impact the sector, cautioned Persistence, but advancements are being made in device technology.

"This approval brings a safe and effective transcatheter therapy to patients who would do very poorly with repeat open-heart surgery," said John Carroll, professor of cardiology at the University of Colorado School of Medicine, director of interventional cardiology at the University of Colorado Hospital, Denver and member of the Transcatheter Valve Therapy Registry steering committee, which studied Edward's device.

The device will serve patients who need a bioprosthetic mitral valve replaced, or have other indications, said Carroll. Edwards submitted data from the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry in its request for indication expansion. The study gathered information on outcomes with TVHR patients in the U.S.

RESULTS AFTER TAVR

The company suggested it would see a boon in profits in early 2017 due to its TVHR additions. In December 2016, the company said the TAVR device was expected to lead revenue in first quarter of 2017. (See Medical Device Daily Dec. 12, 2016.)

Edwards told MDD at that time that the market opportunity with TAVR was expected to exceed $5 billion by 2021.

"The fast growth of the TAVR market continued to drive Edwards Lifesciences' strong performance," said Business Monitor International Ltd. in report on the company's standing in the market. "Investor sentiment will remain contingent upon the fulfilment of the high expectations surrounding the company's TAVR platform as well as its promising product pipeline in mitral and tricuspid valve replacement and repair technologies."

Indeed Edwards' revenue in the sector was reported at $883.5 million in 1Q17, an increase 26.7 percent year over year from $697.3 million in 1Q16 in the sector.

According to a February Business Monitor report, several other small competitors are active in the TVAR and TVMR markets, but are vying against the large companies. "Symetis' acquisition of Middle Peak Medical marks the continuation of a trend that has seen companies looking to mirror their transcatheter aortic valve success in the emerging transcatheter mitral valve (TMV) market via the inorganic growth route. Smaller developers will face difficulties in penetrating the TMV market due to the established presence of structural heart heavyweights." Heart valve replacement solution company, Symetis SA, of Ecublens, Switzerland, acquired Palo Alto, Calif.-based Middle Peak which provided devices for mitral valve regurgitation.

In fact, a major player, Boston Scientific Corp., of Marlborough, Mass., quickly acquired Symetis in March after it ran into some difficulty with its own device, Lotus TAVR. (See Medical Device Daily, March 31, 2017.)

Symetis markets two TAVRs in the EU and was purchased for $435 million in cash.

Boston Scientific previously pulled its Lotus device due to manufacturing concerns, though they plan to adjust and re-enter the market in the EU as well as launch in the U.S. midyear 2018. During the deal, Boston Scientific chairman and CEO Mike Mahoney noted on a conference call the TAVR market was expected to exceed $4 billion by 2020.

Dublin-based Medtronic plc's Corevalve devices for aortic valve replacement are also being studied in the TAVR space. (See Medical Device Daily March 20, 2017.)