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経カテーテル心臓弁置換デバイスの世界市場-2023年~2030年Global Transcatheter Heart Valve Replacement Devices Market - 2023-2030 |
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経カテーテル心臓弁置換デバイスの世界市場-2023年~2030年 |
出版日: 2023年09月27日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 約2営業日
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経カテーテル心臓弁置換(THVR)装置は、機能不全に陥った心臓弁を置換する低侵襲治療に用いられる医療技術です。大動脈弁狭窄症や弁閉鎖不全症などの疾患をお持ちの方は、開胸手術を受けることなく弁置換術を受けることができます。
THVRバルブはカテーテルによって血液動脈に留置され、大腿動脈や同様のアクセスポイントに留置されることが多いです。ウシ、ブタ、またはヒトの組織などの材料で作られた生体弁がTHVR装置を構成しています。これらの弁は、通常の心臓弁と同じように機能するように作られています。置換弁は、THVR装置で見られるフレームやステントを使用して、自然の弁輪内の所定の位置に固定されます。
自己拡張型フレームとバルーン拡張型フレームがあります。THVR装置を使って弁を目的の場所に運ぶと、弁が意図した場所に配置される仕組みになっています。患者の解剖学的構造や健康状態に応じて、経大腿、経肩甲、経大動脈などの異なるアクセスルートが選択されます。
技術進歩
2023年8月、米国食品医薬品局(FDA)はGenesis MedTechのJ-Valve経大動脈(TF)システムを、心臓チームによって本装置の適応があると判断され、かつ開腹手術による大動脈弁置換術のリスクが高いと判断された患者における、重度の生来の大動脈弁閉鎖不全症(AR)およびAR優勢の混合大動脈弁疾患の治療という提案された適応症のブレークスルーデバイスとして指定しました。
この最先端の装置の対象者は、大動脈弁膜症の患者です。心不全は、大動脈弁閉鎖不全症として知られる一般的な疾患から生じる可能性があります。J-Valve経カテーテル大動脈弁置換術は、開心術や体外循環を必要としない、低侵襲の経血管的手法で行われます。この手技では、拡張ステントフレームとアンカー機構を使用して、デバイスを不全弁に固定します。
経カテーテル僧帽弁置換術の利点の増加
僧帽弁疾患,特に僧帽弁狭窄症や逆流症の患者にとって,経カテーテル僧帽弁置換術(TMVR)として知られる新しい医療には多くの利点があります。TMVRでは、血管に小さな穿刺やカテーテルを留置して行うため、大きな外科的切開を必要としません。開心術に比べ、外傷が少なく、苦痛が少なく、回復が早く、感染の可能性も低くなります。
TMVRの患者さんは、通常の外科的僧帽弁置換術を受けた患者さんよりも入院期間が短いことが多いです。その結果、患者さんはより早く治癒し、より早く通常の活動を再開することができます。高齢、脆弱性、追加の内科的疾患の存在などの問題により、開心術のリスクが高い、または手術が不可能と判断された患者さんにとって、TMVRは有益な治療オプションとなります。
FDAの承認
2023年2月、VitaFlow Liberty経カテーテル大動脈弁および回収可能デリバリーシステム(VitaFlow Liberty)とAlwide Plusバルーンカテーテル(Alwide Plus)は、CardioFlow Medtechが独自に開発した経カテーテル大動脈弁植え込み(TAVI)ソリューションとして、タイ食品医薬品局(FDA)から登録承認を受けた。
新世代のTAVI製品であるVitaFlow Libertyは、デリバリーシステムの改良により、オリジナルの経カテーテル大動脈弁およびデリバリーシステム(VitaFlow)の特徴的なデザインを継承しています。その斬新な二重補強スパイラル構造は他に類を見ないものであり、弁セグメントの優れた柔軟性、無方向性、360度の屈曲性を維持しながら、迅速で安定した正確な離脱と回収を可能にします。
心血管疾患の有病率の増加
世界保健機関(WHO)によると、年間1,790万人が死亡しており、心血管疾患(CVD)は世界の死因のトップです。冠動脈性心疾患、脳血管疾患、リウマチ性心疾患、その他の疾患は、CVDとして知られる心臓や血管の疾患のカテゴリーに含まれます。CVDによる死亡の5人に4人以上が心臓発作と脳卒中であり、その3分の1が70歳までに起こっています。
さらに、心臓疾患、特に弁膜症のリスクは、世界の人口が高齢化するにつれて上昇します。大動脈弁狭窄症やその他の弁膜症は高齢者に多く、適切な治療を選択する必要があります。
多額のコスト
経カテーテル的心臓弁置換術(THVR)を含む医療処置や介入の価格は、患者、医療従事者、医療システムのすべてに影響を与える可能性があります。経カテーテル心臓弁そのものが価格のかなりの部分を占めています。多くの場合、生体弁であるこれらの弁の開発と製造には多額の費用がかかります。病院の費用は、手術室の使用、麻酔、看護、回復室のケアなど、さまざまな料金に及びます。
経カテーテル心臓弁の製造には、かなりの量の調査、臨床試験、規制当局の認可、継続的な進歩が必要であり、これらすべてが総費用に上乗せされます。考慮すべきもう一つの要因は、THVR治療を実施し、問題を管理するための医療スタッフの教育費です。
機器の合併症と処置の専門知識の欠如
経カテーテル心臓弁置換術(THVR)のような高度なものであっても、医療手術の世界では、装置の問題と手技知識の不足という2つの重大な要因があります。経カテーテル心臓弁は、時として患者の転帰や手術の効果に影響を与える問題を引き起こす可能性のある医療機器の一例です。
弁が思うように作動せず、弁漏れや不正な血流、弁狭窄(狭窄)を引き起こす可能性があります。THVR法は複雑であり、特殊な知識と専門知識が必要です。医療提供者の経験が浅いと、理想的な結果を得られず、結果を招く可能性があります。
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.
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.
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.
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.
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.
The global transcatheter heart valve replacement devices market report would provide approximately 69 tables, 67 figures and 186 Pages.
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