Anteris Technologies
Women do not have less heart disease than men. They have less representation in the trials, imaging protocols, and device designs that determine who gets treated and how well. In structural heart specifically, that gap has compounded quietly for decades: women present differently in clinic, their disease looks different on imaging, and the devices implanted to save their lives were largely developed without their physiology as a reference point. David St. Denis, President & Director at Anteris Technologies, is one of the few device executives willing to name this problem at each link in the chain and describe what fixing it actually requires. Anteris is currently advancing DurAVR, a next-generation aortic valve replacement designed to restore healthy physiology, including in patients with smaller anatomies and late-stage disease. In this conversation, St. Denis walks through why detection fails women first, where the device industry’s responsibility begins, and what the clinical evidence base still cannot tell us.
Why are women underrepresented in structural heart trials and treatment, even when the disease burden is comparable?
David: It’s multifactorial. A lot of it has to do with how men and women present in clinic differently. And because of those differences, there’s a bias toward recognizing the disease in men more frequently and referring them to treatment more frequently. It doesn’t mean women have the disease more often or more severely. It just means the system as it’s set up right now is biased toward detecting it in men rather than women.
How does that diagnostic bias play out in a disease like aortic stenosis specifically?
David: When a man comes in, he’ll say he has chest pain, he’ll be passing out, he’ll have shortness of breath. These are all very clear markers of the disease. And phenotypically, men tend to have more calcific disease, so when they go for assessment, the imaging modalities we use pick up calcification and they’re diagnosed.
Women tend to express their symptoms slightly differently. The way those symptoms get expressed very often ends up being associated more with just the consequence of normal aging. You can kind of miss it: “You’re just slowing down, you’re just getting a little tired,” because they’re not presenting the very specific symptoms doctors are looking for today. Then if they are caught and they do go into the diagnosis phase, their disease tends to be more fibrotic rather than calcific. And fibrosis tends to show up less on the imaging modalities we use. So there are multiple points in that process where women can fall through the cracks.
“We need to be educating patients, first and foremost, specifically women about this disease and how to advocate for themselves in the clinic, how to describe their symptoms, how not to diminish their symptoms by just saying, ‘I’m just getting older, I’m just slowing down.’”
How does a device company’s responsibility extend into a diagnostic pipeline it doesn’t control?
David: The medical device industry has the solution to the disease, but we’re not the ones diagnosing it. That said, I think our responsibility starts with patient education. If women are more educated and advocating for themselves in the clinic, they may be intervened with earlier and they may have a better long-term outcome. That’s the first consequence.
Beyond that, we need to be working with our partners in the imaging space to say: how can we try to pick up this disease for both men and women? Can we change some of our algorithms so we’re more likely to catch it? And yes, it does involve education for healthcare providers, working with key opinion leaders, making sure the right voices are represented. Health systems, doctors, manufacturers in med device and diagnostics all have a role. But the biggest role we all have to play is educating patients to know how to advocate for themselves.
How does device design itself need to change, and who gets left out when it’s designed universally?
David: As we’ve developed these devices, we’ve developed them not with the physiology of a woman in mind. And it’s not just women, by the way. It’s also certain populations of men who happen to have smaller anatomies. What we’re starting to do now is say: we can’t look at this universally by an entire group. We have to look at each patient’s phenotype, their anatomy, and understand fundamentally what we have to do differently in device development to adapt to the needs of that patient.
A woman, or a man in this case with a very small anatomy and a low-flow, high-gradient presentation, requires a device that functions differently than somebody else who needs something different. And I think you’re starting to see that contemplated in the new devices coming through.
Why do clinical trials have to change before device design can fully catch up?
David: The first thing we need to do is have clinical trials that include more women. The outcomes data we have today is based on blended populations. And as we know from areas like cancer and immunotherapy, there can be far more than surface-level differences between men and women. The more trials we conduct that include larger female populations, the more data we generate, and the more may appear to tell us: actually, we need to be designing things specifically for this population versus that one. We don’t have that data today, so everything gets blended in.
At least the industry I’m in now has really started to pay attention to this. Companies are designing trials to include women more thoughtfully and more deliberately. Once we generate a compendium of clinical evidence, we’ll have clues as to where to focus next.
“The more trials we do that include larger populations of women, the more data we gather, the more may appear to us to say, ‘Actually, we need to be designing things specifically for this population versus that population.’ We don’t have that data today.”
How does late-stage detection change what the device itself needs to do?
David: If unfortunately women slip through the cracks, as is often the case, and they are detected at all, it’s often very, very late. That’s where next-generation therapies like Anteris’s DurAVR come in, because we’ve designed the product to restore healthy physiology. In a patient who’s in very late-stage disease, while we may not be able to return them completely to health, we’re going to give them the best chance at stopping the progression of disease and, hopefully, returning them to some level of health so they can be active again, have a normal quality of life, and hopefully many more years of life. We’ll see that as the data reads out. But that’s really the key focus.
David St. Denis is President & Director at Anteris Technologies, a structural heart company developing next-generation aortic valve replacement therapies.
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
