Global Transcatheter Mitral Valve Repair Devices Market - 2023-2030

Overview

The global transcatheter mitral valve repair devices market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. Rising cardiovascular disorders, research and development and government investments in medical devices are among the key drivers impacting transcatheter mitral valve repair devices globally. After the challenging year of 2020, the transcatheter mitral valve repair devices industry showed moderate resilience and adaptability.

Government investments in cardiovascular disorders, particularly in developing economies, will continue to drive transcatheter edge-to-edge repair (TEER) devices and boost the global transcatheter mitral valve repair devices market. The global transcatheter mitral valve repair devices industry is placing increasing emphasis on better management of mitral regurgitation. The respective initiatives includes the use of other devices, such as annuloplasty devices and transcatheter chordal repair for treatment of mitral regurgitation.

The transcatheter edge-to-edge repair (TEER) device type, accounts for over half of the market share. Similarly, the North America dominates the transcatheter mitral valve repair devices market, capturing the largest market share of over 1/3rd. The region's rapid investments in healthcare and rising major players in the transcatheter mitral valve repair devices market globally, makes it the largest market share holder. United States has the largest pool of manufacturers as well as consumers.

Dynamics

Growing Research and Development by the Researchers

Developed economies have been witnessing rapid growth in betterment of their healthcare sectors, driven by rising income levels, investments and infrastructure development. Several countries have experienced substantial demand for transcatheter mitral valve repair devices, reflecting their expanding healthcare industries. Rising research and development will be a crucial factor driving the growth of the market.

Recent improvements in medical and transcatheter therapy have greatly expanded the options for treating secondary mitral regurgitation (SMR). An important study called the Cardiovascular Outcomes Evaluation of the MitraClip Percutaneous Therapy for Cardiac Failure Patients alongside Functional Mitral Regurgitation (COAPT) trial demonstrated that mitral valve transcatheter edge-to-edge repair (M-TEER) using the second version of the MitraClip system enhances prognosis as well as quality life expectancy in heart failure individuals who have reduced LV ejection fraction (LVEF) and SMR.

In order to further minimize MR and improve procedural outcomes in problematic mitral valve (MV) anatomies, current scientific advancement in the area of M-TEER focuses on improving device design and increasing device sizes. These developments might lead to a reduction in symptoms of heart failure and possibly a better prognosis for SMR patients who would not otherwise be eligible for M-TEER because of anatomic challenges.

Rising Number of Funding or Investments

One of the primary drivers of the global Transcatheter Mitral Valve Repair Devices market is robust pipeline, especially in emerging economies and rising investments and funding. For instance, on November 23, 2022, a medical device firm named Nyra Medical, Inc. has announced the completion of a $20 million Series A fundraising. The company is developing a revolutionary transcatheter mitral valve replacement technology. Epidarex Capital, Broadview Ventures, and the Georgia Research Alliance Venture Fund were among investors in the round, which was co-led by Vensana Capital and a significant, international medical equipment firm.

The financing's proceeds will be utilized to support Nyra's technology via preliminary clinical trials of viability. In order to address inadequacies that might otherwise result in mitral regurgitation while maintaining the natural valve shape, Nyra is working on a transcatheter technique called CARLEN that changes the native mitral valve leaflets through a proprietary implant.

Challenges and Limitations Associated with the Devices

For MR with various etiologies, various approaches should be used. For all MR causes, the TEER has the greatest research data and the most convincing proof of therapeutic success. Only individuals with secondary MR can receive an annuloplasty, however leaflet repair and more excellent advancements may be on the horizon. The effectiveness of chordal repair in treating central posterior leaflet prolapse has been examined exclusively in low-risk individuals; further research is required to support the efficacy, safety, and long-term effects of this procedure in high-risk patients.

Despite the minimally invasive transfemoral method, a low death rate, and rapid recovery following TMVr, several drawbacks of this strategy as well as the intricacy of MV illness and anatomy cannot be denied. TMVr's primary drawback is that MR decline is less predictable and could continue or recur. Recurrence rates may be higher in individuals who have functional MR because of more cardiac remodeling including the repair device's partial MV occlusion during systole. Transcatheter repair operations are also frequently technically difficult, and occasionally an array of devices is needed to guarantee the procedure's efficacy.

Complications or Risks Related to the Device

The anchoring force of the transcatheter heart valve (THV) is produced by friction between the transcatheter prosthetic mitral valve's frame and the surrounding tissue. As a result, deployment in a bad spot could reduce this force and cause misposition or migration. One patient was hospitalized again with heart failure in Cheung TMVR case study of 23 consecutive patients who underwent mitral ViV.

Echocardiography revealed 5-mm valve migration to the anterior left atrium with significant intervalvular regurgitation, necessitating a second uneventful transapical (TA) TMVR. Guerrero's valve-in-mitral annular calcification (ViMAC) study revealed that five transcatheter valve embolization (TVE) patients needed a second THV, and six patients experienced implanted device migration.

Segment Analysis

The global transcatheter mitral valve repair devices market is segmented based on device type, indication, end user and region.

High Advantages and Advancements of Transcatheter Edge-to-Edge Repair Devices

A minimally invasive treatment called mitral transcatheter edge-to-edge repair (TEER) is used to treat mitral valve regurgitation, a disease where the valve between the left chambers of the heart doesn't seal completely. Each time the heart beats, healthy heart valves securely open and close to regulate blood flow from the heart and back to the other parts of the body. Blood seeps backward if the mitral valve isn't closing properly, which makes the heart work harder. People may feel exhausted or out of breath as a result of a buildup of pressure in the lungs. In the absence of medical care, the regurgitation (backflow) may develop over time and manifest new symptoms.

In TEER, a tiny device is implanted in the valve to aid in its more complete closure and the restoration of regular blood flow utilizing either the Pascal Precision or Abbott MitraClip systems. These tools function by bringing the flaps of the valve into a more straight-forward alignment. They are put through an artery using a catheter, which is a long, thin tube. As a result, only a little incision is needed for the treatment. Feeling short of breath, chest pain, and other symptoms can be reduced thanks to TEER, which also enhances quality of life.

Geographical Penetration

North America Accounted for Largest Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Due to the rising need for transcatheter mitral valve repair devices in healthcare, manufacturers in North America have chances of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for transcatheter mitral valve repair devices.

Increasing expenditure on healthcare and rising research studies, advancement of technologies for different devices for mitral regurgitation, and increase in pharmaceutical and medical devices business establishment across the region are also contributing to the growth of transcatheter mitral valve repair devices market share of this region.

The key healthcare organizations' and businesses' joint research initiatives are also expected to contribute to the rising demand, as will new product development, which constantly looks to improve present options. The market in this area is growing as people become more aware of various novel devices such as annuloplasty devices, for treatment purposes. The aforementioned elements further attest to North America's hegemonic position in the world.

North America continues to be a key player in the global transcatheter mitral valve repair devices market, with United States leading the way. Government initiatives promoting infrastructure development and investment, and a focus on rising cardiovascular disorders have fueled the demand for transcatheter mitral valve repair devices in the region. United States have been proactive in executing several initiatives or researches, stimulating transcatheter mitral valve repair devices demand.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global transcatheter mitral valve repair devices market. As countries grappled with lockdowns, supply chain disruptions and reduced economic activity, the medical device sector, with a significant consumer of transcatheter mitral valve repair devices, was significantly impacted.

Several efforts all throughout the world were impacted by the pandemic's broad lockdowns and limitations that started in early 2020. Major pharmaceutical or medical device industries came to a standstill and shifted their attention towards the management of COVID-19, leading to a slump in demand for transcatheter mitral valve repair devices. As a result, many medical device plants either suspended or reduced production to align with the reduced demand.

The COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials to the pharmaceuticals manufacturing plants. Movement limitations and border closures caused production and supply delays. Additionally, some nations experienced a lack of raw resources as a result of supply chain network interruptions.

With the outbreak of the pandemic, many pharmaceutical or medical device manufacturing units faced labor shortages as workers fell sick or were unable to travel to work due to lockdown restrictions. To curb the spread of the virus, pharmaceutical plants implemented stringent safety measures, reducing the number of workers allowed on-site at a time. However, these measures were vital to safeguard the health of the workforce and maintain essential operations during the pandemic.

Russia-Ukraine War Impact Analysis

The medical device businesses are starting to worry regarding their capacity to continue operating, much like other parts of the world. Russia's invasion of Ukraine has an effect on millions of people not only in this nation in Eastern Europe but also all around the world. Device developers will thus experience delays in the development process, a loss of business consistency, and the possibility of non-compliance for drugs already on the market.

For many years, clinical trials in several therapeutic fields have benefited significantly from the participation of Ukraine, Russia, and other CIS nations. Clinical trial durations can frequently be accelerated by incorporating more patients into studies when there is availability to skilled investigators, high-quality patient populations, and big patient populations. Trials that are delayed in Russia and Ukraine as well as relocation to other regions of Europe for fresh trials are currently viable choices. These factors will impact the global transcatheter mitral valve repair devices market.

By Device Type

• Annuloplasty Devices
  • Direct Annuloplasty
  • Indirect Annuloplasty
    • Transcatheter Edge-to-Edge Repair (TEER) Devices
    • Transcatheter Chordal Repair

By Indication

• Mitral regurgitation (MR)

• Primary Mitral Regurgitation
• Secondary Mitral Regurgitation
  • Mitral Stenosis (MS)

By End User

• Hospitals
• Specialty Clinics
• Others

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

• On September 17, 2022, results from CLASP IID, a groundbreaking controlled, randomized study that directly contrasts two cutting-edge transcatheter edge-to-edge repair (TEER) procedures, were released by Edwards Lifesciences Corporation. According to the study, TEER is a safe and efficient treatment option for those having degenerative mitral regurgitation (DMR). Findings from the CLASP IID essential trial were concurrently published in JACC: Cardiovascular Interventions and offered as a late-breaking clinical research meeting at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the yearly scientific conference of the Cardiovascular Research Foundation.
• On June 8, 2022, MitraClip, the first transcatheter edge-to-edge repair (TEER) device in the world, and TriClip, a pioneering minimally invasive tricuspid heart valve repair technology, both received late-breaking data announcements from Abbott. The statistics support the structural cardiac solutions offered by the company's for mitral as well as tricuspid regurgitation (MR or TR) in a wide spectrum of patient populations struggling with leaky heart valves.

Competitive Landscape

The major global players in the market include Abbott, Edwards Lifesciences Corporation, Cardiac Dimensions, NeoChord, Inc., 4C Medical Technologies, Nyra Medical, Shockwave Medical Inc., Coramaze Technologies, Boston Scientific Corporation and Medtronic among others.

Why Purchase the Report?

• To visualize the global transcatheter mitral valve repair devices market segmentation based on device 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 mitral valve repair 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 mitral valve repair devices market report would provide approximately 61 tables, 58 figures and 186 Pages.

Target Audience 2023

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