The $10B TAVR Market Grew. Why Are Most Patients Still Untreated?

After decades of device-delivery progress, the next era of TAVR must be judged by valve design, physiologic blood flow, and clinical outcomes. With DurAVR^® THV, Anteris is bringing a pharma-style disease-management mindset to a category long defined by engineering.

MINNEAPOLIS, July 13, 2026 /PRNewswire/ -- A $10 billion transcatheter aortic valve replacement (TAVR) market can still be an underdeveloped disease category. Aortic stenosis narrows the heart's aortic valve, restricting blood flow from the heart to the rest of the body. Despite the severity of the disease, Anteris Technologies estimates that only about 20% of patients with the condition currently receive treatment. Recent national analyses showing rising aortic stenosis mortality among adults ages 55 to 64 further suggest that underdiagnosis and delayed referral remain significant challenges.

For Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris, a global structural heart company, that disconnect reflects an industry that has focused more on procedural growth than disease management.

Anteris is positioning DurAVR^® THV not as another incremental TAVR device, but as a category reset. "Medtech spent 20 years optimizing the path to the valve. A pharma approach asks whether the therapy changed the disease," said Paterson. "That is the standard structural heart now has to meet: not successful delivery, but measurable restoration of the heart."

A Pharma Playbook for a Stalled Device Category

Paterson's critique is not only about valve design. It is about how traditional medtech has treated TAVR as a procedure: build the device, refine the delivery system, and train physicians. Anteris is applying a pharmaceutical model by defining the disease, identifying untreated patients, showing the clinical effect, and building the market around patient outcomes.

According to Paterson, that approach changes the competitive question. If aortic stenosis remains underdiagnosed and undertreated, the industry cannot be considered mature because the procedure has been adopted by physicians. Instead, success should be measured by whether the patients are seeing meaningful improvement in heart function.

"In pharma, you do not build a category by talking about delivery mechanisms," Paterson said. "You build it by proving the clinical result and showing why that result matters to the disease. That is the discipline we are bringing to structural heart."

A Category Reset Has to Be Tested Head-to-Head

The PARADIGM trial is the proof point behind Anteris' argument. Rather than relying on historical comparisons or device-generation claims, the trial puts DurAVR^® THV directly against commercially available TAVR devices.

The need for comparative evidence is growing. As TAVR moves into younger and lower-risk patients, the American College of Cardiology has noted that long-term durability beyond 10 years remains unknown and that lifetime valve management should begin at the first procedure. Six-year results from the Evolut Low Risk trial showed higher reintervention rates after TAVR than after surgical aortic valve replacement, reinforcing growing attention on long-term valve performance.

• At six years, repeat valve interventions were 5.5% after TAVR versus 3.3% after surgery.
• In available seven-year data, rates rose to 9.8% after TAVR versus 6% after surgery.

The PARADIGM trial is intended to evaluate not only whether DurAVR^® THV can be implanted safely, but whether its biomimetic design supports the performance standards Paterson believes should define the next era of TAVR: lower gradients, improved blood flow, and evidence that the heart is moving closer to healthy function.

"Structural heart should not be afraid of comparative data," Paterson said. "If a valve is supposed to change how aortic stenosis affects the heart, then we should measure that directly."

The Next TAVR Era Will Be Built on Outcomes

As TAVR expands into younger and lower-risk patients, Paterson argues the industry's next challenge is no longer proving the procedure works. It is proving which valve designs produce the best long-term outcomes. Recent data reinforce that challenge: symptomatic severe aortic stenosis affects approximately 250,000 people annually in the U.S. and remains undertreated. At the same time, a 2026 study found that electronic clinician notifications increased valve intervention by 40% and multidisciplinary heart-team evaluations by 27% within 90 days.

That is where Paterson believes a pharma-style approach matters. Drug categories are not built only by proving that therapy can be administered. They are built by defining the untreated population, identifying the right endpoints, proving clinical effect, and expanding care around outcomes.

DurAVR^® THV reflects Anteris' effort to move beyond device iteration by testing whether biomimetic design can support a different standard of care based on comparative evidence, physiologic restoration, and measurable heart recovery. "The first era of TAVR proved that structural heart could change the procedure," Paterson said. "The next era must prove it can change the disease."

About Anteris Technologies

Anteris Technologies is a structural heart company redefining transcatheter aortic valve replacement (TAVR) through next-generation biomimetic valve innovation designed to restore healthy cardiac physiology and improve long-term patient outcomes. The company's DurAVR^® platform is engineered to replicate natural valve function and laminar blood flow, advancing a new standard of care focused on physiologic restoration, durability, and lifetime heart performance. Through rigorous clinical validation and patient-centered innovation, Anteris is helping shape the future of structural heart therapy.

For more information, visit https://anteristech.com/.

Sources

• American College of Cardiology. (2026, April 13). Transcatheter aortic valve implantation: Durability and management of transcatheter valve failure. acc.org/latest-in-cardiology/articles/2026/04/13/18/35/transcatheter-aortic-valve-implantation
• Cardiovascular Business. (2026, March). TAVR linked to higher reintervention rate than SAVR in Evolut Low Risk trial update. cardiovascularbusiness.com/topics/clinical/structural-heart-disease/tavr/tavr-linked-higher-reintervention-rate-savr-evolut-low-risk-trial-update
• Medtronic. (2026, March 29). Medtronic study reveals AI-enabled clinician alerts significantly improve evaluation and valve intervention for patients with heart valve disease. medtronic.com/Medtronic-study-reveals-AI-enabled-clinician-alerts-significantly-improve-evaluation-and-valve-intervention-for-patients-with-heart-valve-disease
• Rahman, S. U. (2026, March 31). National trends in aortic stenosis mortality in the pre- and post-TAVR eras in the United States, 1999 to 2023. Journal of Invasive Cardiology. hmpgloballearningnetwork.com/site/jic/conference-coverage/national-trends-aortic-stenosis-mortality-pre-and-post-tavr-eras

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SOURCE Anteris Technologies