Cardiovascular disease may be one of medicine’s oldest battlegrounds, but some of its most important technologies are still evolving — and not always as quickly as patients, and investors, might expect.
Nowhere is that more evident than in transcatheter aortic valve replacement (TAVR), a market dominated for more than a decade by two global giants: Edwards Lifesciences Corp (NYSE:EW, XETRA:EWL) and Medtronic PLC (NYSE:MDT, XETRA:2M6). Their flagship devices — Sapien and Evolut — have transformed the treatment of aortic stenosis, a life-threatening narrowing of the aortic valve that restricts blood flow and can lead to heart failure or death if left untreated.
Yet those devices, for all their success, still reflect incremental design changes — and force clinicians to navigate trade-offs between ease of use and optimal performance. At the same time, their expanded use in lower-risk and younger patient populations is creating a new unmet need, as patients live longer and, in some cases, outlast the performance of earlier-generation implants.
That tension is central to the strategy at Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR), which is advancing a fundamentally different valve design through its DurAVR program — an “entirely new class of TAVR”, according to Debbie Ormsby, Anteris’ vice president of global investor relations and corporate development. She explained that, eight years ago, the company spotted an opportunity to use its existing expertise and technology and “design a valve from scratch” based on what clinicians were asking for: a balloon-expandable delivery system that is “clinically better” than the market-leading Sapien system.
“When we went into this, instead of looking at the competitors and saying we want to mimic what Medtronic or Edwards has done, we asked the clinicians what they wanted, and then looked to actually mimic the native valve,” Ormsby said. “Because, ultimately, that’s our competitor — we want to restore patients to their pre-disease state.”
A market built for older patients — now treating younger ones
TAVR was originally developed for patients too frail to undergo open-heart surgery — often in their 80s, with multiple comorbidities. The procedure itself was revolutionary: instead of cracking the chest, doctors could insert a replacement valve via a catheter, typically through the femoral artery, and have patients walking again within days.
But the success of that approach changed the patient population.
Because of TAVR’s strong safety profile, regulatory shifts in 2019 expanded the availability of the procedure to lower-risk patients, bringing younger, healthier individuals into the treatment pool. That shift has had unintended consequences.
“The valves that are on the market at the moment were not really developed for today’s patients,” Ormsby said. “What’s happening now is that these patients are actually outliving their valves, and so they’re needing another valve replacement.”
This has given rise to a new and growing “valve-in-valve” replacement market — which Ormbsy notes did not even exist when DurAVR was originally being developed — and exposed durability and performance limitations in existing designs.
At the same time, the broader opportunity remains underpenetrated. A high proportion of severe aortic stenosis cases are currently untreated, despite the condition carrying a high mortality rate if left unmanaged.
Two dominant players — and a persistent trade-off
Despite the size of the market — projected to reach around US$10 billion by 2028 — it remains unusually concentrated.
Edwards’ Sapien valve holds roughly 70% market share in the United States, with Medtronic’s Evolut accounting for the remainder. But that dominance is not purely a function of clinical performance, which in practice has proven secondary to ease of use.
“The reason the Edwards valve is market leader is not because it’s a better valve in the sense of the outcomes it gets for patients, but because it is delivered on a balloon,” Ormsby explained.
Sapien uses a balloon-expandable catheter system that is faster, more predictable and easier for clinicians to use. Evolut, by contrast, is self-expanding — offering better haemodynamic, or blood flow, performance but requiring more complex positioning and longer procedure times.
The result is a trade-off that has shaped the market for years: ease of use versus optimal blood flow.
"With current market leading therapies, patients are often left with residual mild aortic stenosis," Ormsby said. "At the moment, clinicians are having to compromise between ease of use and physiologic valve performance.”
Designing a valve from scratch
That trade-off became the starting point for Anteris Technologies.
Rather than iterating on existing designs, the company’s leadership — including vice chairman and CEO Wayne Paterson — took a different approach: start with a blank sheet of paper and ask clinicians what they actually wanted.
The answer was clear:
- a balloon-expandable delivery system for ease of use; and
- “clinically better” performance than the market leaders.
“Essentially, they were looking for curative, pre-disease haemodynamics,” Ormsby said.
“Those were the two objectives that these particular clinicians gave us. In order to be able to do that, we had to completely change the design of the valve.”
Where existing valves are typically constructed from three pieces of stitched tissue, Anteris developed a single-piece, moulded valve using its proprietary ADAPT tissue — designed to behave more like a natural aortic valve and reduce calcification risk over time.
DurAVR valve before balloon-expansion
The result is DurAVR, a device that combines balloon-expandable delivery with haemodynamic performance that compares favourably even with the self-expanding Evolut system.
DurAVR valve after balloon-expansion
In simple terms: ease of use without the compromise on blood flow — a pairing renowned cardiothoracic surgeon Dr Michael Reardon, who has referred to as “the holy grail” of his field.
Beyond mechanics: A shift towards ‘total disease management’
That design philosophy reflects a broader difference in how Anteris approaches the market.
Unlike many traditional medtech players, Ormsby explained, the company draws heavily on pharmaceutical industry thinking — particularly around treating the whole disease, not just the mechanical problem.
"Historically, medtech has focused on valve-centric hemodynamic metrics, such as mean pressure gradient and effective orifice area rather than the downstream impact of metrics such as physiologic flow dynamics and the potential for left ventricular remodelling, which ultimately drive outcomes," she said.
A key distinction in haemodynamic performance is laminar versus turbulent flow. Where many current valves produce turbulent flow, DurAVR is designed to deliver laminar flow — a smoother, more efficient movement of blood that more closely resembles a healthy valve and may reduce long-term strain on the heart.
Early data — and a pivotal test ahead
Early clinical results have supported Anteris’ performance ambitions.
In a cohort of difficult-to-treat patients with small annuli, DurAVR demonstrated strong haemodynamic performance, including low pressure gradients and minimal prosthesis-patient mismatch.
The company has now treated more than 130 patients across early studies, with follow-up extending beyond four years in some cases.
The next phase is the PARADIGM pivotal trial — a global, randomised study enrolling around 1,000 patients and directly comparing DurAVR against Sapien and Evolut.
The trial’s primary endpoint is non-inferiority on major outcomes such as mortality, stroke and cardiovascular hospitalisation — but its secondary endpoints are designed to highlight differentiation on haemodynamics and broader disease metrics.
A head-to-head design of this kind is relatively uncommon in medtech registration studies, reflecting confidence in the product’s performance.
Strategic backing — and commercial ambition
That confidence has also been reflected in the company’s capital position.
In early 2026, Anteris completed a US$320 million capital raise, including a US$90 million strategic investment from Medtronic — one of the very incumbents it aims to challenge.
The investment, which does not grant Medtronic control, provides validation of both the technology and the market opportunity.
“We’re up on the podiums at the major conferences, shoulder to shoulder with Edwards and Medtronic, even though we’re pre-commercial,” Ormsby said. “What the company is doing is very much taking the science forward.”
Looking ahead, Anteris is pursuing a dual strategy: advance towards full commercialisation while remaining open to partnerships or strategic deals.
A familiar market — with a new angle
For investors, the story is not just about one device; it’s about a market that has been remarkably stable — and arguably under-innovated — for more than a decade, despite its size and clinical importance.
“The two valves on the market are essentially just iterations of the same platform,” Ormsby said, which has amounted to “10 years with no real innovation”.
DurAVR, by contrast, represents a more fundamental rethink — one that attempts to resolve a long-standing trade-off at the heart of TAVR.
“Our valve has been designed from the ground up with clinicians to address an unmet need in today’s evolving TAVR market,” Ormsby said.
“There’s a lot that we can do with this product,” she added. “If you have those two components, where you’re getting superior haemodynamics and you’ve got a delivery system the clinicians want to use, it’s meeting that gap in the market at the moment.”