When Cardiovascular News sits down with Annette Brüls at the 2025 European Society of Cardiology (ESC) congress (29 August–1 September, Madrid, Spain), Edwards Lifesciences’ corporate vice president for EMEA, Canada, and Latin America is in a bullish mood, buoyed by the release of new European guidelines for the management of valvular heart disease which, in her words, underscore the growing confidence in transcatheter therapies for the treatment of aortic, mitral and tricuspid valve disease.
For a company that has bet big on growth in the structural heart field—selling its Critical Care business in mid-2024 to fund a slew of investments and acquisitions in its structural heart portfolio—the guidelines’ strengthened recommendations for transcatheter therapies represent a welcome development.
Headlines from the latest guideline document—which has been jointly compiled by both the ESC and the European Association for Cardio-Thoracic Surgery (EACTS)—include a new, lower, age threshold for transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis, a class IIb recommendation for transcatheter procedures for patients with atrial secondary mitral regurgitation, as well as stronger backing for transcatheter procedures in the treatment of tricuspid valve disease.
The guidelines also nudge clinicians towards earlier intervention in selected asymptomatic patients with severe aortic stenosis, supported in part by evidence from the Edwards sponsored EARLY TAVR trial, in which it was shown that patients randomised to TAVI with the Edwards Sapien 3 platform experienced superior outcomes compared to clinical surveillance.
“We have been working on this for many years, and it is a new era,” says Brüls of this update. “For patients with severe aortic stenosis, they should now be considered for treatment, even independent of having symptoms and independent of their ejection fraction—which is major.”
Brüls believes there is a case to be made from both a patient and a healthcare provider perspective in treating more asymptomatic aortic stenosis—which, she says can exceed some forms of cancer for mortality if left untreated—and makes the argument that more proactive management of the disease can reduce burden on healthcare systems.
“Until now, the guidelines were saying you have to wait until you have symptoms, but these can be severe symptoms, hospitalisations, decompensation and deaths. With our latest technologies, the risk related to an intervention is really close to zero and there is no reason to wait.”
She acknowledges, however, that there will be significant challenges in many regions in moving towards a more proactive treatment approach, particularly in regard to treatment capacity, with some healthcare systems already facing sizeable waiting lists, and says that Edwards, with a fresh CE mark indication for the Sapien valve for the treatment of asymptomatic aortic stenosis, has a role to play in helping to bring this therapy to patients at an earlier stage in the treatment pathway.
“We have to find ways in this constricted system to help to get ahead of the curve, because otherwise it only gets worse. Once you start to get ahead of the curve, these emergent cases will diminish and then suddenly you get to a new steady state which is much better, so I think we need to manage that transition carefully.
“The good news is it all starts with the guidelines. Now we have a mandate to look at these patients, and I think that is the big breakthrough.”
In particular, Edwards is seeking to highlight the potential cost effectiveness of early intervention, with data presented at EuroPCR 2025 (20–23 May, Paris, France) pointing towards lower healthcare system costs, shorter hospital length of stay, and fewer rehospitalisations when patients were treated before symptom onset.
Outside of TAVI, Brüls underlines Edwards’ ambition across the structural heart space, with recent acquisitions bolstering the company’s established device portfolio which includes the Pascal mitral repair system and Evoque tricuspid valve replacement system.
“If you look at structural heart disease it is probably one of the most innovative areas, and most complex areas that there is in interventional cardiology. The advancements that we can make there are massive. There are a lot of unmet needs,” she comments.
“We see it as an area that is highly complex but where we have a lot of expertise. We have been in the space of helping patients with valvular disease for 65 years, we are the category leader, so we believe we have the expertise to bring in new areas. It is a huge unmet need which has a huge impact on society, these patients are decompensated, they have heart failure, they are frequently hospitalised, so it is really one of these patient populations where the clinical but also the economic benefit for the system is massive, and we are the pioneers.”
Brüls comments that Edwards has sought out potential disruptors in the structural heart space as it seeks to refocus its business solely into this segment.
Acquisitions and investments announced by the company over the last 12 months include the proposed agreement to acquire JenaValve, maker of the Trilogy TAVI system for the treatment of aortic regurgitation, JC Medical, which is also developing a device for aortic regurgitation, Innovalve Bio Medical, developer of an early-stage transcatheter mitral valve replacement (TMVR) technology, as well as an agreement with Affluent Medical relating to the company’s mitral valve technologies, and a deal to acquire Endotronix, the developer of the Cordella pulmonary artery (PA) sensor, an implantable heart failure patient management platform.
In August 2025, the US Federal Trade Commission (FTC) moved to block the JenaValve acquisition due to concerns that the acquisition would limit access to devices for the treatment of aortic regurgitation due to Edwards, however Brüls tells Cardiovascular News that the company remains committed to seeing the deal over the line. “I can say that we are committed to this and we will do everything we can,” she comments. “We think we have very compelling arguments, that show that this is a very good thing for patients, for innovation, and that with our knowledge and expertise we can really bring to market and to patients, so we are continuing.”
