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全球凝块管理设备市场 - 2023-2030

Global Clot Management Devices Market - 2023-2030

出版日期: 2023年09月27日 | 出版商:

DataM Intelligence | 英文 186 Pages | 商品交期: 约2个工作天内

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简介目录

概述

血栓管理设备旨在预防、识别和治疗与血栓相关的问题。这些设备用于治疗深部静脉栓塞 (DVT)、肺栓塞 (PE) 和动脉血栓等疾病。使用血栓切除装置机械去除动脉中的血栓。这些工具可以应用于腿部、肺部、大脑以及其他身体部位。机械血栓切除工具和抽吸导管是两个例子。

导管导引导管用于血栓溶解装置，将溶栓药物直接输送至凝块。这些药物有助于溶解血栓并恢復血液流动。 DVT、PE 和其他疾病经常以导管溶栓治疗。动脉血栓、肺栓塞和深部静脉血栓等血管疾病的盛行率呈上升趋势，增加了对血栓管理设备的需求。

医疗技术的不断发展使得开发更有效率、微创的血栓管理工具成为可能，从而改善患者的治疗效果并加速康復。

动力学

FDA 核准

例如，2023 年 1 月，专注于尖端药物的全球医疗保健公司 Penumbra, Inc. 报告称，市场上最先进、最有效的机械血栓切除系统 Lightning Flash 已获得美国食品和药物管理局批准使用管理（FDA ）。 Lightning Flash 中采用了 Penumbra 创新的 Lightning 智慧抽吸技术和双凝块侦测演算法。 Lightning Flash 旨在结合尖端导管工程，快速清除体内大血栓，例如静脉血栓和肺栓塞 (PE)。

由 Penumbra ENGINE 驱动的 Lightning Flash 使用基于压力和流量的演算法来识别血栓和血流。用于製造 Lightning Flash 导管的 MaxID 海波管技术可实现与大口径导管相当的内径，同时保持低调和柔软、无创伤的尖端，旨在帮助导航身体复杂而精緻的结构。该设备的组合使用旨在促进快速清除血块，同时限制潜在的失血。

活跃的主要参与者

2023年3月，在印度国内一些地区，SMT表示已被选为Penumbra外周和冠状血管取栓技术的独家经销商。根据合约条款，SMT 将向医疗保健提供者提供 Penumbra 最新的 Indigo 系统产品组合，包括最近获得印度中央药品标准控制组织批准的 CATTM RX 以及经监管部门批准后用于治疗冠心病等疾病的 Lightning 技术血栓形成、静脉血栓、动脉血栓和肺栓塞。

凭藉闪电抽吸管，Penumbra 的 Indigo 系统产品组合是第一个也是唯一一个可以区分凝块和血液、减少失血的电脑辅助机械抽吸技术。它设计用于单次清除週边动脉和静脉系统中的血块，包括治疗肺栓塞。此外，Penumbra 的 Indigo System CAT RX 能够安全有效地清除冠状动脉和周边动脉中的血栓。

加强关键参与者之间的合作

2023年6月，智慧医疗器材领域领导者Sensome与全球导丝产业领导者Asahi Intecc强力联手，打造新一代Clotild智慧导丝。 Asahi Intecc 将负责製造这种用于治疗急性缺血性中风的突破性设备。

后天性长期残疾最常见的原因是脑缺血性中风，可以透过机械血栓切除术来治疗。此手术使用血栓切除工具，沿着导线从手腕或腹股沟引导到阻塞部位，以去除阻塞大脑动脉的血栓。轻鬆快速去除血栓，显着改善患者的治疗效果。

心血管疾病盛行率增加

据世界卫生组织称，每年有 1790 万人死亡，心血管疾病 (CVD) 是全球死亡的主要原因。冠心病、脑血管疾病、风湿性心臟病和其他疾病都属于心臟和血管疾病（CVD）的范畴。每 5 例 CVD 死亡中就有超过 4 例是由心臟病发作和中风造成的，其中三分之一的死亡发生在 70 岁之前。

根据发表在《美国心臟病学会杂誌》上的一项研究，预计到2060 年，美国心血管危险因子和疾病的发病率将大幅上升。心血管趋势的显着上升可能会给人们带来更大的压力。美国的医疗保健系统强调需要公平地获得早期疾病预防服务，包括教育和治疗。

设备成本高

深入的工程、研究和临床测试对于创造新的医疗设备都是必要的，并且它们都增加了将产品推向市场的整体价格。製造商必须花钱进行彻底的测试和文书工作，以遵守严格的安全性和有效性监管标准，这增加了成本。

医疗器材经常需要符合严格的无菌、耐用性和生物相容性要求的专用材料。获取和处理这些资源的成本可能很高。使用尖端技术生产复杂的医疗器材可能需要复杂的製造程序、训练有素的人员和品质控管程序。

技术挑战

在创建具有复杂设计和功能的医疗设备时，确保所有组件一起正常运作可能会出现技术困难。确保与当前医疗工具、实践和工作流程的兼容性可能很困难，特别是在将新设备合併到成熟的基础设施中时。

为了安全有效地使用设备，必须为医护人员设计使用者友善、直觉的介面。复杂的循环系统必须透过导管进行导航，同时限制对周围组织的伤害，这需要专业知识和高科技成像指导。

Overview

Clot management devices are intended to prevent, identify, and treat problems linked to blood clots. Deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis are among the disorders that these devices are used to treat. Blood clots in blood arteries are mechanically removed using thrombectomy devices. These tools can be applied to the legs, lungs, and brain, among other body areas. Mechanical thrombectomy tools and aspiration catheters are two examples.

Catheter-Directed Catheters are used in thrombolysis devices to deliver thrombolytic drugs directly to the clot. These drugs aid in dissolving the clot and resuming blood flow. DVT, PE, and other diseases are frequently treated with catheter-directed thrombolysis. The prevalence of vascular diseases such as arterial thrombosis, pulmonary embolism, and deep vein thrombosis is on the rise, which has boosted the demand for clot management devices.

The development of more efficient and minimally invasive clot management tools has been made possible by ongoing developments in medical technology, improving patient outcomes and speeding up recovery.

Dynamics

FDA Approvals

For instance, in January 2023, Penumbra, Inc., a worldwide healthcare firm focused on cutting-edge medicines reported that the most sophisticated and potent mechanical thrombectomy system on the market, Lightning Flash, has been approved for use by the U.S. Food and Drug Administration (FDA). Penumbra's innovative Lightning Intelligent Aspiration technology with twin clot detection algorithms, is featured in Lightning Flash. Lightning Flash is intended to quickly remove big blood clots from the body, such as venous thrombus and pulmonary emboli (PE), in conjunction with cutting-edge catheter engineering.

The Penumbra ENGINE-powered Lightning Flash uses pressure- and flow-based algorithms to identify blood clots and blood flow. The MaxID hypotube technology used to create the Lightning Flash catheter allows for an inner diameter that is comparable to large-bore catheters while keeping a low profile and a soft, atraumatic tip intended to aid in navigating the intricate and delicate structure of the body. The device's combined use is meant to facilitate fast blood clot removal while limiting potential blood loss.

Active Major Players

In March 2023, in some domestic Indian regions, SMT stated that it had been chosen as the sole distributor of Penumbra's peripheral and coronary vascular thrombectomy technology. In accordance with the terms of the contract, SMT will offer healthcare providers Penumbra's most recent Indigo System portfolio, including CATTM RX, which recently received approval from India's Central Drug Standard Control Organization, and Lightning technologies, upon regulatory approval, to treat conditions like coronary thrombosis, venous thrombosis, arterial thrombosis, and pulmonary embolism.

With Lightning Aspiration Tubing, Penumbra's Indigo System portfolio is the first and only computer-aided mechanical aspiration technology that can distinguish between clot and blood, reducing blood loss. It is designed for single-session blood clot removal in peripheral arterial and venous systems, including the treatment of pulmonary embolism. Additionally, Penumbra's Indigo System CAT RX is made to remove blood clots from the coronary and peripheral arteries safely and effectively.

Increasing Collaboration Among Key Players

In June 2023, Sensome, a leader in the field of smart medical devices, and Asahi Intecc, a global leader in the guidewire industry, joined forces to create the next-generation Clotild Smart Guidewire. Asahi Intecc will be responsible for manufacturing this ground-breaking device for the treatment of acute ischemic stroke.

The most common cause of acquired long-term disability is a cerebral ischemic stroke, which is treatable with a treatment called mechanical thrombectomy. This procedure uses a thrombectomy tool that is guided along a wire from the wrist or groin to the blockage site to remove a clot that is clogging a blood artery in the brain. Rapid clot removal with little effort significantly improves patient outcomes.

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.

According to a study that was published in the Journal of the American College of Cardiology, the estimated rates of cardiovascular risk factors and disease will considerably rise in the United States by the year 2060. Significant rises in cardiovascular trends could place a greater strain on the American healthcare system and underscore the need for fair access to early disease preventive services including education and treatment.

High Cost of Devices

In-depth engineering, research, and clinical testing are all necessary for the creation of new medical devices, and they all add to the overall price of bringing a product to market. Manufacturers must spend money on thorough testing and paperwork in order to comply with severe regulatory criteria for safety and efficacy, which raises the cost.

Specialized materials that adhere to strict requirements for sterility, durability, and biocompatibility are frequently needed for medical devices. The cost of obtaining and processing these resources can be high. Complex manufacturing procedures, trained personnel, and quality control procedures may be needed to produce intricate medical devices with cutting-edge technology.

Technical Challenges

Technical difficulties in ensuring that all components perform properly together can arise when creating medical devices with complex designs and functionalities. It can be difficult to ensure compatibility with current medical tools, practices, and workflows, particularly when incorporating new devices into mature infrastructures.

For devices to be used safely and effectively, user-friendly, intuitive interfaces for healthcare workers must be designed. Complex circulatory systems must be navigated with catheters while limiting injury to the surrounding tissues, which calls for expertise and high-tech imaging guidance.

Segment Analysis

The global clot management devices market is segmented based on type, end-user and region.

Catheter Directed Thrombolysis Devices Dominate the Market

Deep vein thrombosis (DVT) or pulmonary embolism are two conditions in which blood clots (thrombi) are clogging blood vessels in the legs. Catheter-directed thrombolysis (CDT) is a medical procedure used to treat both conditions. A small, flexible tube called a catheter is placed into the damaged blood artery. Typically, a small incision is used, and imaging methods like fluoroscopy or ultrasound are used to direct the catheter to the clot's location.

A thrombolytic agent, commonly referred to as a clot-dissolving medicine, is administered directly into the clot through the catheter. By dissolving the fibrin strands holding the clot together, thrombolytics enable the body's clot-dissolving systems to clear the impediment. Depending on the size and location of the clot, the length of time the drug is administered can change. The clot is intended to gradually dissolve, allowing blood flow to return. The remnants of the disintegrated clot may occasionally be naturally removed by blood flow. In other situations, the catheter could be utilized to manually or suctionally remove the clot fragments.

Geographical Penetration

Advanced Healthcare Infrastructure, Increased Cardiovascular Disease

North America has been a dominant force in the global clot management devices market. Pulmonary embolism (PE) is a major cause of illness burden. PE is the third biggest cause of cardiovascular disease-related death in the United States, where it is expected to cause 100,000 fatalities annually.

There is growing evidence that prompt and thorough thrombus removal in deep vein thrombosis leads to better results, such as a lower incidence of post-thrombotic syndrome and incapacitating long-term symptoms. Catheter-directed thrombolysis works well to remove clots quickly, however, treatment comes with a high risk of bleeding. Without the need for systemic or catheter-directed thrombolytic therapy, percutaneous mechanical thrombectomy is a very efficient way to remove clots.

For instance, Edwards Lifesciences Corporation offers the Fogarty graft thrombectomy catheter. AV fistulas for dialysis access and grafts for iliofemoral bypass are two examples of synthetic bypass grafts that are intended to be cleaned of organized thrombus and adhering thrombotic debris. They provide a wider range of diameters than the Fogarty adherent clot catheter, which is useful for a thrombus that is too resistant for an elastomeric balloon.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global clot management devices market. Many healthcare systems reallocated resources to deal with COVID-19 cases at the height of the pandemic. Non-urgent medical operations, such as those involving clot management, were consequently delayed.

The management of COVID-19 patients took over hospitals' and healthcare facilities' attention, which had an impact on the resources available for treating other medical disorders. Patient visits to healthcare facilities for conditions unrelated to COVID-19 decreased because of lockdowns, limits on movement, and patient fears of getting the virus.

Russia-Ukraine War Impact Analysis

Healthcare systems may be under pressure by armed situations that take resources and focus away from treatments involving clot management devices. The violence may interrupt supply lines for medical equipment and supplies, which could influence the accessibility of clot control devices.

Patients' ability to reach medical facilities and receive timely clot management therapies is hampered by the conflict. Elective procedures like clot management interventions are delayed if healthcare facilities prioritize urgent cases over non-urgent ones.

By Type

Embolectomy Balloon Catheter
Catheter Directed Thrombolysis Devices
Percutaneous Thrombectomy Devices
Inferior Vena cava Filters
Neurovascular Embolectomy Devices
Others

By End-users

Hospitals
Ambulatory Surgical Centers
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

In August 2022, Inari Medical announced a trial for the ClotTriever system to treat iliofemoral deep vein thrombosis (DVT).

Competitive Landscape

The major global players in the market include Medtronic Plc, Boston Scientific Corporation, Edward Lifesciences, Teleflex Incorporated, Johnson & Johnson, LeMaitre Vascular, Inc., AngioDynamics, iVascular SLU, Cardinal Health, and Stryker.

Why Purchase the Report?

To visualize the global clot management devices market segmentation based on product, end-users, 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 clot management 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 clot management 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

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product
3.2. Snippet by End-users
3.3. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. FDA Approval
  - 4.1.1.2. Active Major Players
  - 4.1.1.3. Increasing Collaboration Among Key Players
  - 4.1.1.4. Increasing Prevalence of Cardiovascular Diseases
- 4.1.2. Restraints
  - 4.1.2.1. High Cost of Devices
  - 4.1.2.2. Technical Challenges
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Russia-Ukraine War Impact Analysis
5.6. DMI Opinion

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID
- 6.1.2. Scenario During COVID
- 6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. By Product

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 7.1.2. Market Attractiveness Index, By Product
7.2. Embolectomy Balloon Catheter*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Catheter Directed Thrombolysis Devices
7.4. Percutaneous Thrombectomy Devices
7.5. Inferior Vena cava Filters
7.6. Neurovascular Embolectomy Devices
7.7. Others

8. By End-user

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
- 8.1.2. Market Attractiveness Index, By End-user
8.2. Commercial and Infrastructure*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Residential
8.4. Industrial

9. By Region

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 9.1.2. Market Attractiveness Index, By Region
9.2. North America
- 9.2.1. Introduction
- 9.2.2. Key Region-Specific Dynamics
- 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
- 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.2.5.1. U.S.
  - 9.2.5.2. Canada
  - 9.2.5.3. Mexico
9.3. Europe
- 9.3.1. Introduction
- 9.3.2. Key Region-Specific Dynamics
- 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
- 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.3.5.1. Germany
  - 9.3.5.2. UK
  - 9.3.5.3. France
  - 9.3.5.4. Italy
  - 9.3.5.5. Spain
  - 9.3.5.6. Rest of Europe
9.4. South America
- 9.4.1. Introduction
- 9.4.2. Key Region-Specific Dynamics
- 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
- 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.4.5.1. Brazil
  - 9.4.5.2. Argentina
  - 9.4.5.3. Rest of South America
9.5. Asia-Pacific
- 9.5.1. Introduction
- 9.5.2. Key Region-Specific Dynamics
- 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
- 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.5.5.1. China
  - 9.5.5.2. India
  - 9.5.5.3. Japan
  - 9.5.5.4. Australia
  - 9.5.5.5. Rest of Asia-Pacific
9.6. Middle East and Africa
- 9.6.1. Introduction
- 9.6.2. Key Region-Specific Dynamics
- 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user

10. Competitive Landscape

10.1. Competitive Scenario
10.2. Market Positioning/Share Analysis
10.3. Mergers and Acquisitions Analysis

11. Company Profiles

11.1. Medtronic Plc*
- 11.1.1. Company Overview
- 11.1.2. Product Portfolio and Description
- 11.1.3. Financial Overview
- 11.1.4. Key Developments
11.2. Boston Scientific Corporation
11.3. Edward Lifesciences
11.4. Teleflex Incorporated
11.5. Johnson & Johnson
11.6. LeMaitre Vascular, Inc.
11.7. AngioDynamics
11.8. iVascular SLU
11.9. Cardinal Health
11.10. Stryker

LIST NOT EXHAUSTIVE