Global Transcatheter Heart Valve Replacement Devices Market - 2023-2030

Overview

Transcatheter Heart Valve Replacement (THVR) devices are medical technologies used in minimally invasive treatments to replace failing heart valves. With the help of these devices, individuals with diseases like aortic stenosis or regurgitation can receive the benefits of a replacement valve without undergoing open heart surgery.

THVR devices are made to be placed into blood arteries by catheters, frequently in the femoral artery or some similar access point. Bioprosthetic valves made of materials like bovine, porcine, or human tissues make up THVR devices. These valves are made to perform similarly to how normal heart valves do. The replacement valve is fixed in place within the natural valve annulus using frames or stents seen in THVR devices.

Self-expanding or balloon-expandable frames are both options. When a valve is brought to the target location using THVR devices, mechanisms allow the valve to be deployed in the intended location. Depending on the anatomy and health of the patient, different access routes, such as transfemoral, transapical, or transaortic, may be selected.

Market Dynamics

Technological Advancements

In August 2023, the U.S. Food and Drug Administration (FDA) designated Genesis MedTech's J-Valve Transfemoral (TF) System as a Breakthrough Device for the proposed indication of treating severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients who are determined by a heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

The target audience for this cutting-edge device is people with aortic valvular disease. Heart failure can result from the common condition known as aortic regurgitation. A minimally invasive transvascular technique is used to accomplish the J-Valve Transcatheter aortic valve replacement treatment, eliminating the requirement for open heart surgery or extracorporeal circulation. The technique uses an expanding stent frame and an anchor mechanism to secure the device to a failing valve.

Increasing Benefits of Transcatheter Mitral Valve Replacement

For patients with mitral valve disease, particularly mitral stenosis or regurgitation, the novel medical treatment known as transcatheter mitral valve replacement (TMVR) has a number of advantages. The use of major surgical incisions is less necessary with TMVR because it can be done through tiny punctures or catheters placed into blood vessels. Compared to open heart surgery, this leads to less trauma, less suffering, quicker recovery times, and a lower chance of infection.

TMVR patients often stay in the hospital for less time than patients who have standard surgical mitral valve replacement. Patients can heal more quickly and resume their regular activities earlier as a result. For patients who are deemed high-risk or inoperable for open-heart surgery due to issues including advanced age, fragility, or the presence of additional medical disorders, TMVR offers a beneficial therapy option.

FDA Approval

In February 2023, the VitaFlow Liberty Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty) and the Alwide Plus Balloon Catheter (Alwide Plus), CardioFlow Medtech received registration approval from the Food and Drug Administration, Thailand for its independently developed Transcatheter aortic valve implantation (TAVI) solutions.

With an improvement to the delivery system, VitaFlow Liberty, a new-generation TAVI product, carries over the original Transcatheter Aortic Valve and Delivery System (VitaFlow)'s distinctive design. Its novel double-reinforced spiral construction is one-of-a-kind and enables quick, stable, and accurate release and retrieval while preserving the valve segment's excellent flexibility, non-directionality, and 360-degree bending.

Increasing Prevalence of Cardiovascular Diseases

According to the World Health Organization, with 17.9 million deaths per year, cardiovascular diseases (CVDs) are the leading cause of death worldwide. Coronary heart disease, cerebrovascular disease, rheumatic heart disease, and other illnesses are among the categories of heart and blood vessel disorders known as CVDs. Heart attacks and strokes account for more than four out of every five CVD deaths, and one-third of these deaths happen before the age of 70.

In addition, the risk of heart disorders, particularly valvular problems, rises as the world's population ages. Aortic stenosis and other valvular disorders are more prevalent in elderly people, need appropriate treatment choices.

High Cost

Patients, healthcare professionals, and healthcare systems may all be impacted by the price of medical procedures and interventions, including transcatheter heart valve replacement (THVR). The transcatheter heart valve itself accounts for a sizable portion of the price. The development and production of these valves, which are often bioprosthetic, is costly. Hospital expenses cover a range of fees, such as the use of operating rooms, anesthesia, nursing care, and recovery room care.

Transcatheter heart valve creation requires a substantial amount of research, clinical testing, regulatory clearances, and continual advancements, all of which add to the overall cost. Another factor to take into account is the price of educating medical staff to carry out THVR treatments and manage problems.

Device Complications and lack of Procedural Expertise

Two crucial factors in the world of medical operations, even sophisticated ones like transcatheter heart valve replacement (THVR), are device issues and a lack of procedural knowledge. Transcatheter heart valves are one example of a medical device that might occasionally result in issues that can affect patient outcomes and the effectiveness of the surgery.

The valve might not work as it should, which could cause leakage, incorrect blood flow, or valve stenosis (narrowing). The THVR method is intricate and necessitates specific knowledge and expertise. Healthcare providers' inexperience can result in less-than-ideal results and possible consequences.

Segment Analysis

The global transcatheter heart valve replacement devices market is segmented based on type, product, indication, end-users and region.

The transcatheter aortic valve replacement segment accounted for approximately 45.3% of the market share

As per the article published in Stat Pearls in 2023, patients with severe symptomatic aortic stenosis (AS) typically have surgical aortic valve replacement. Before, patients who were deemed to be at high risk for surgery could only get palliative treatments like diuretics and balloon valvuloplasty, which had little impact on long-term outcomes. For patients deemed to be inoperable, the discovery of Transcatheter aortic valve replacement (TAVR) has emerged as a lifeline, offering both a reduction in symptoms and a statistically significant mortality benefit.

There are numerous transcatheter aortic valves on the market. However, only the SAPIEN valves from Edwards Lifesciences in Irvine, California, and the CORE valves from Medtronic in Fridley, Minnesota, are now FDA-approved for use in the United States. Bovine pericardial tissue and a chromium-cobalt alloy frame make up the SAPIEN valves. The SAPIEN valves can expand like a balloon. The EVOLUT-R valve is part of Medtronic's most recent iteration. Porcine tissue and a nitinol frame make up its construction.

Geographical Penetration

Presence of Major Players and Increasing Prevalence of Cardiovascular Disease

North America has been a dominant force in the global transcatheter heart valve replacement devices market. For instance, in June 2023, egnite, Inc., a leading digital health company for cardiovascular care, and JenaValve Technology, Inc., a developer and manufacturer of differentiated Transcatheter aortic valve replacement (TAVR) systems, collaborated to understand the treatment model and associated outcomes for patients with aortic regurgitation (AR).

The partnership uses the market-leading database of egnite to measure prevalence and treatment trends. It is conservatively estimated that approximately 500,000 people are diagnosed with moderate or severe AR in the United States. They seek to accelerate change, offer better treatment alternatives, and ultimately save lives by leveraging cutting-edge analytics and JenaValve's inventive Transcatheter treatments. These findings encourage additional focus on enhancing outcomes for patients with AR by offering insightful information to politicians and healthcare professionals.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global transcatheter heart valve replacement devices market. Many hospitals and healthcare facilities delayed elective treatments during the early stages of the pandemic, including THVR, in order to devote resources to COVID-19 patients.

As a result, THVR procedures decreased. Due to concerns about contracting the virus in medical facilities during the pandemic, many people were reluctant to have elective surgeries. As a result, there were fewer patients for THVR surgeries. The traditional patient-provider relationship necessary for THVR evaluations was impacted when more healthcare professionals and patients used telemedicine for consultations and follow-up appointments.

Russia-Ukraine War Impact Analysis

Healthcare systems in the impacted areas may be under stress as a result of armed conflicts, which may take resources and focus away from elective operations like THVR. Hospitals may need to give emergency patients priority over elective procedures. Security concerns, infrastructural damage, and population displacement in conflict zones might restrict patients' access to medical facilities.

This affected a patient's eligibility for THVR procedures. The displacement of medical personnel due to conflict may result in a shortage of skilled workers qualified to carry out difficult treatments like THVR.

By Product

• Self-Expandable Transcatheter Aortic Valves
• Ballon Expandable Transcatheter Aortic Valves
• Mechanically Expandable Transcatheter Aortic Valves

By Procedure Type

• Transcatheter Aortic Valve Replacement
• Transcatheter Mitral Valve Replacement
• Transcatheter Pulmonary Valve Replacement

By Indication

• Severe Aortic Valve Stenosis
• Aortic Regurgitation
• Others

By End-users

• Hospitals
• Ambulatory Surgical Centers
• Cardiac Catheterization Laboratories

By Region

• North America
  • U.S.
  • Canada
  • Mexico

• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe

• South America
  • Brazil
  • Argentina
  • Rest of South America

• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific

• Middle East and Africa

Key Developments

• In May 2023, JenaValve Technology, Inc., a developer and manufacturer of differentiated Transcatheter aortic valve replacement (TAVR) systems, the first two Trilogy Heart Valve System implantations in Asia were completed.

Competitive Landscape

The major global players in the market include Abbott, Edwards Lifesciences Corporation, Medtronic plc., Boston Scientific Corporation, JenaValve Technology, Inc., Meril Life Sciences, Sahajanand Medical Technologies Limited, MicroPort Scientific Corporation, Venus Medtech (Hangzhou) Inc., and Peijia Medical Limited.

Why Purchase the Report?

• To visualize the global transcatheter heart valve replacement devices market segmentation based on product, procedure type, indication, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of transcatheter heart valve replacement devices market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global transcatheter heart valve replacement devices market report would provide approximately 69 tables, 67 figures and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies