ARTICLE SUMMARY:
Market leaders Medtronic and Edwards explore new applications as competitors enter the TAVR market. Excerpted from our recent feature article.
According to Jefferies Equity Research, the worldwide transcatheter aortic valve replacement (TAVR) market will be worth nearly $7 billion annually by the end of 2024, up from $4.6 billion in 2019, and Jefferies expects the market to grow around 11% annually over the next three years. Overall, the market has grown about 50% since 2019. The US TAVR market accounts for just over half of the total worldwide market and will grow about 10% annually over the next three years.
Transcatheter aortic valve replacement (TAVR) has been an important growth driver for Medtronic and Edwards Lifesciences over the past decade and both companies are continuing to press their advantage as new competitors enter the TAVR market.
According to Jefferies Equity Research, the worldwide TAVR market will be worth nearly $7 billion annually by the end of 2024, up from $4.6 billion in 2019, and Jefferies expects the market to grow around 11% annually over the next three years. Overall, the market has grown about 50% since 2019. The US TAVR market accounts for just over half of the total worldwide market and will grow about 10% annually over the next three years.
Led by the Sapien 3 Ultra Resilia balloon-expandable TAVR system, Edwards dominates the TAVR market, controlling about 60% worldwide and more than 70% in the US. Medtronic is the number two TAVR competitor with about 28% worldwide and 24% in the US; the latest generation of Medtronic’s CoreValve self-expanding TAVR system is called the Evolut FX+.
Edwards was the first company to launch a TAVR system in the US when it introduced the original Sapien system in 2011 following US Food and Drug Administration approval. The Centers for Medicare and Medicaid Services (CMS) began national Medicare coverage for TAVR in 2012, and the first version of Medtronic’s CoreValve joined the US market in 2014.
Much of the market’s growth over the last decade has been driven by indication expansions. Initially, TAVR was only FDA-approved and Medicare-covered for patients with severe symptomatic aortic stenosis who would be at high risk for complications during surgery as assessed by the Society of Thoracic Surgeons (STS) risk score. That only accounted for about 6% of patients with severe aortic stenosis, so Medtronic and Edwards supported clinical trials demonstrating the safety and efficacy of their devices in intermediate- and low-risk patients, who account for about 14% and 80% of aortic stenosis patients, respectively. Supported by those trials, the FDA eventually expanded the labeling for TAVR to include the intermediate- and low-risk patients. And in 2019, Medtronic’s CoreValve devices and Edwards’ Sapien devices were approved by FDA for all patients with symptomatic, severe aortic stenosis, regardless of their surgical risk.
Like all first movers in a new market, Medtronic and Edwards Lifesciences are losing worldwide market share to newer entrants. Boston Scientific launched the Acurate neo2 TAVR system in Europe in 2020. Abbott rolled out Navitor, the successor to its Portico TAVR device, in Europe in 2022 and launched it in the US in 2023.
Abbott only controls about 2% of the US TAVR market and 4% of the market worldwide, but that represents rapid progress since the company first launched the self-expanding Portico TAVR system in the US in 2021.
Boston Scientific has struggled to catch up with the established players. The company launched the Lotus Edge mechanically expanded TAVR system in Europe and the US in 2019. It was designed to be fully repositionable and retrievable and featured a depth guard and unique adaptive seal. However, problems with the delivery system proved too costly to overcome, so the company recalled Lotus Edge in 2020. Since then, Boston Scientific has focused on developing its Acurate neo2 TAVR system, which has taken about 10% of the European TAVR market over its four years on the market. The company is also developing the next-generation Acurate Prime TAVR system, which will be available in larger sizes and features an enhanced frame for “superior performance in complex cases.” Boston Scientific plans to launch Acurate Prime in Europe in October.
As the market matures for the established applications, by sponsoring clinical trials for new indications Edwards and Medtronic are trying to expand the population that can be treated with TAVR. One emerging prospective application could be asymptomatic patients. About one-third of patients with severe aortic stenosis do not report symptoms. Traditionally, these patients have been treated with “watchful waiting” followed by aortic valve replacement if the patient develops significant symptoms or ventricular systolic dysfunction.
Another potential population: patients with smaller annuli, Including women. About 40% of patients with aortic valve stenosis have small aortic annuli, increasing their risk for impaired hemodynamic performance and associated adverse cardiovascular clinical outcomes following a valve replacement. Medtronic believes it may have an edge in this population because the CoreValve systems are self-expanding and install the new valve in the supra-annular—above the annulus—position. Edwards’ Sapien valves are deployed with a balloon catheter in the intra-annular position within the annulus. Since the early days of TAVR, about 14 years ago, proponents of the self-expanding design have suspected it could be a better option than the balloon-expanding valves in patients with small annuli.