FDA Approval of TAVR in Low-Risk Patients Set to Drive Market Growth

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Based on the latest market analysis by iData Research, the Transcatheter Aortic Valve Replacement (TAVR) market was valued at $2,424 million in 2020, which is a 13% decline from 2019 due to COVID19. TAVR is a minimally invasive procedure to replace the diseased aortic valve in patients with severe aortic stenosis.  Aortic stenosis is by far the most common type of aortic valve problem, with more than 1.2 million Americans, mostly over 65 years old, having calcified aortic valves.

For decades, open heart surgical aortic valve replacement (SAVR) has been the standard treatment for severe aortic stenosis, but recently TAVR has rapidly replaced SAVR in high-risk patients as well as patients at moderate risk for surgery. This is due to excellent clinical trial results showing equal or better patient outcomes compared to SAVR. However, this does not come without reservations as many skeptics are concerned over the long-term durability of valves and some of the possible safety concerns.

Approval of TAVR for Low-risk Patient Profile Set to Propel Market

In August 2019, the FDA expanded indications for transcatheter heart valves to include low-risk patients. The Edwards SAPIEN 3® and Medtronic’s CoreValve Evolut R® system both received approval for this indication on the same day. The approval was widely anticipated following the success of clinical trials with both products performing on par or better than traditional surgical methods.  This new approval greatly expands the number of patients that can be treated in this minimally invasive way. It is predicted that up to 50% of all TAVR patients could be classified as low-risk by 2026.

The market will be partially propelled by the national media attention garnered by the clinical success in low-risk patients. Many surgeons have observed an increase in patients requesting TAVR over SAVR due to the minimally invasive nature of the procedure. However, the main limiting factor in this expansion is the lack of long-term durability clinical data. As part of the approval process, the patients enrolled will be monitored to determine long-term valve durability over a ten-year period.

CEPDs Set for Expansion Following Approval of Low-Risk Patients for TAVR

The benefit of TAVR is attenuated by the occurrence of major disabling stroke which is associated with increased mortality and early-reduced quality of life. Despite advances in TAVR technology, stroke remains a serious complication that is associated with significant negative outcomes. The majority of these occur in the acute phase following TAVR where cerebral embolic events are frequent. Cerebral embolic protection devices have been developed to minimize the risk of peri-procedural ischemic stroke during TAVR, and it is expected that almost 40% of TAVR procedures in the U.S. will use CEPD by 2026.

Following the acquisition of Claret Medical in 2018, Boston Scientific is the only company offering a CEPD approved by the FDA in the U.S. market. It is likely that a greater number of CEPDs will be deployed in the future as these devices gain acceptance for TAVR procedures. The market is set to be further driven by the approval of the Sentinel™ device by the CMS for a new technology add-on payment. This means that hospitals will be reimbursed for up to half of the cost of the product, lessening the economic impact of adding cerebral embolic protection to a TAVR procedure.

Market Share Changes in the US TAVR and CEPD Markets

Boston Scientific entered the TAVR market in April 2019 following FDA approval of its LOTUS Edge™ aortic valve system. The device is designed to grant physicians greater control during replacement by allowing physicians to assess the final position of the valve prior to its release. It is the first fully repositionable and retrievable TAVR device available in the U.S., however, it is only currently approved for patients in the high-risk category.

While Edwards LifeSciences and Medtronic compete for share in the recently approved low-risk patient category, Boston Scientific will be aiming to persuade physicians to switch to its LOTUS Edge™ device for patients at high risk of surgery. Boston Scientific may also look to bundle the sale of its LOTUS Edge™ valve with its cerebral embolic protection device (CEPD), Sentinel™. The company is currently recruiting intermediate-risk patients for the REPRISE IV clinical trial. Thus, the impact that Boston Scientific will have in the TAVR market is likely to depend on approval in various patient groups.

US Transcatheter Aortic Valve Replacement Market Forecast

As the TAVR got approved for use in low-risk patients, the growth in the market will be limited by the lack of clinical data on long-term patient outcomes and valve durability. However, as stroke remains a serious complication that is associated with the procedure, multiple companies will be monitoring how the adoption of Cerebral Embolic Protection Devices (CEPD) happens across the market.

Register to receive a free TAVR Market Report Suite for the US 2020-2026 synopsis

It is anticipated that number of TAVR procedures performed with CEPD is expected to more than triple by 2026. According to the market analysis by iData Research, the US TAVR market size is expected to reach a valuation of almost $5 billion by 2026, growing at around 8% when compared to 2019.

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