The Edwards-CardiAQ mitral valve is anticipated to receive CE Mark in 2018.
2017 is set to be a transformative year for Edwards Lifesciences' transcatheter mitral and tricuspid device pipeline.
The company detailed its multi-pronged approach to treating mitral and tricuspid regurgitation during its December 8 analyst meeting. That strategy includes a mitral valve replacement option with the Edwards-CardiAQ transcatheter mitral valve, functional mitral repair with its pending acquisition of Valtech Cardio and an internal repair system called PASCAL, degenerative mitral repair with its equity investment with option to acquire in Harpoon Medical, and tricuspid repair through its pending Valtech Cardio acquisition and the Edwards FORMA tricuspid spacer.
Edwards-CardiAQ Mitral Valve
As MD+DI has reported before, Edwards is one of several medical device players focused on the large transcatheter mitral valve replacement market. There have been more than 20 cases performed with the mitral valve, with about half of those cases using a transseptal delivery approach, Donald Bobo, Jr., corporate vice president of strategy and corporate development at Edwards, told analysts during the company's analyst day. He explained that physicians prefer using a transseptal delivery system.
"As physicians had an option to start early with the transapical or wait a couple months for transseptal, they were not ambiguous. They said, 'We'll wait for the transseptal,'" Bobo said.
Management has said before that a CE Mark study of its Edwards-CardiAQ mitral valve is set to start by the end of 2016, though enrollment is still pending at this point.
"The regulatory process in Europe has gotten a little more complicated," Bobo said. "Compared to what we would do 7-8 years ago to get a trial started, the bar has gone up significantly and it's a lot more rigorous. Each country is a little different, so our cadence of regulatory approval for CE Mark trial was slower." He added that the fact that early clinical feedback allows for learning and "re-teaching" has impacted the enrollment timeline as well.
The company announced this week that it is targeting CE Mark in 2018 for the Edwards-CardiAQ mitral valve.
Valtech Cardio Acquisition
Edwards recently announced its plan to acquire Valtech Cardio, which makes the Cardioband System for transcatheter mitral and tricuspid valve repair. Over 125 patients at 20 centers have been treated with the Cardioband System for mitral regurgitation reduction, Bobo noted.
"We find the data that they've generated on reduction in mitral regurgitation and the stability of that reduction at one year and two years to be particularly interesting and we find that very promising," Bobo said.
The device has CE Mark for transseptal mitral repair and a CE Mark trial for tricuspid valve repair has been started, with CE Mark anticipated in 2018.
A U.S. pivotal trial is expected to begin in 2017. "We think this offers an incredibly flexible repair approach for many patients who are simply suffering from enlarged annulus," Bobo said.
PASCAL Transcatheter Mitral Repair
Edwards has also been developing a transseptal mitral repair option in house with its PASCAL system, which is designed as a spacer that is attached between valve leaflets. Bobo introduced the system, explaining that it may be well-suited for elderly patients or patients with primary leaflet problems.
PASCAL has been studied in a European early feasibility first-in-man study for degenerative and functional mitral regurgitation. A CE Mark study is expected to begin in 2017 as well.
Harpoon Medical Investment
A year ago, Edwards announced a structured investment in transcatheter mitral valve repair company Harpoon Medical with an exclusive option to buy. The Harpoon device is designed to provide beating-heart degenerative mitral repair and has been used in 40 patients. A CE Mark for the device is expected in 2017.
FORMA Tricuspid Spacer Implant
The FORMA Tricuspid Spacer Implant is designed to fill in the gaps between tricuspid valve leaflets in order to reduce tricuspid regurgitation.
"This is a novel concept, where it puts a spacer in between the leaflets that have been moved apart because of the annular dilatation," Bobo said.
There have already been more than 25 early clinical cases performed with FORMA. Edwards has projected CE Mark for the device in 2018.
"We believe that these programs reflect the complex anatomy of the mitral and tricuspid valve," Bobo said. "[We] also respect the historical interventions that have proven successful and tries to leverage the transcatheter progress that has been made around catheters, devices, imaging, procedural expertise to deliver these therapies using transcatheter techniques."
Yet the technologies are still mainly early stage. "We're also aware that there are a lot of risks. It's early, and it's going to take long-term investment," Bobo said.
[Image courtesy of EDWARDS LIFESCIENCES]