Transcatheter aortic valve replacement (THVR) is approved for patients suffering from symptomatic severe aortic stenosis or regurgitation and is recommended for high risk patients suffering from other chronic diseases who need to undergo cardiac surgery.

Statistics:

The global Transcatheter Heart Valve Market is estimated to account for US$ 7,642.7 Mn in terms of value by the end of 2027

Global Transcatheter Heart Valve Market: Drivers

Increasing demand for minimally-invasive procedures is expected to boost growth of the global transcatheter heart valve market over the forecast period. THVR procedure helps to reduce morbidity and mortality rate, offers faster recovery time, and has less postoperative complications compared to conventional procedures.

Global Transcatheter Heart Valve Market: Opportunities

Favourable reimbursement policies in various countries are expected to offer lucrative growth opportunities for players in the market. In the U.S., Medicare covers reimbursement for patients whose aortic heart valves are damaged and need replacement. In May 2012, the Centers for Medicare and Medicaid Services (CMS) and Food & Drug Administration (FDA) jointly approved insurance coverage for TAVR in high risk patients with severe aortic stenosis.

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Global Transcatheter Heart Valve Market: Restraints

Clinical trials for transcatheter heart valve products are time consuming and require significant capital investment. Product failure in final phases of clinical trials can lead to major losses to the company. This in turn is expected to hinder growth of the global transcatheter heart valve market. For instance, in September 2014, MicroPort Medical (Group) Co., Ltd. submitted its transcatheter aortic valve device for FDA approval. Its results are expected to be announced by September 2021.

Key Takeaways

The TAVR segment in the global transcatheter heart valve market was valued at US$ 2,331.7 Mn in 2019 and is expected to reach US$ 6,054.9 Mn by 2027 at a CAGR of 12.7% during the forecast period.Increasing demand for minimally-invasive procedures is expected to boost growth of the segment during the forecasted period.

The Transfemoral Approach segment held dominant position in the global transcatheter heart valve market in 2019, accounting for 85.1% share in terms of value, followed by Transapical Approach, respectively. Increasing product approvals is anticipated to drive the growth of the segments during the forecast period

Market Trends

Major players in the market are focused on conducting clinical trials to expand their produxt portfolio. For instance, in November 2019, Meril, a company based in India, announced that its MyVal-1 transcatheter heart valve demonstrated a high procedural success rate in a one-month clinical trial for patients at intermediate or high risk for surgical aortic valve replacement.

Increasing R&D in TAVR is expected to aid in growth of the market. For instance, in October 2019, researchers from University Heart Center Hamburg reported that implantation of the self-expanding Biovalve transcatheter heart valve for the treatment of severe aortic stenosis was safe.

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Regulations

In the U.S., the premarket approval (PMA) process can be broken down into four basic stages.
Pre-Investigational Device Exemption/Preclinical Evaluation
IDE/Clinical Testing
Data Review—PMA (Stage III)
Post-market Approval (Stage IV)

The PMA process is initiated by the medical device company with a series of meetings with FDA/CDRH focused on preclinical (bench and animal) testing as well as plans for a clinical trial.

The FDA works with the sponsor to develop a plan that may include specifics regarding site/physician training, post market surveillance registries, and studies.

Global Transcatheter Heart Valve Market: Competitive Landscape

Major players operating in the global transcatheter heart valve market include, Edwards Lifesciences Corporation, Medtronic, Boston Scientific Corporation, Abbott, JenaValve Technology, SYMETIS, and Braile Biomedica.

Global Transcatheter Heart Valve Market: Key Developments

August 2019: Edwards Lifesciences announced to recall its SAPIEN 3 Ultra delivery system. The U.S. FDA identified this as a Class I recall

August 2019: Medtronic plc received the U.S. Food and Drug Administration approval for its Evolut TAVR system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality

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