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1352134

全球凝塊管理設備市場 - 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: 約2個工作天內

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簡介目錄

概述

血栓管理設備旨在預防、識別和治療與血栓相關的問題。這些設備用於治療深部靜脈栓塞 (DVT)、肺栓塞 (PE) 和動脈血栓等疾病。使用血栓切除裝置機械去除動脈中的血栓。這些工具可以應用於腿部、肺部、大腦以及其他身體部位。機械血栓切除工具和抽吸導管是兩個例子。

導管導引導管用於血栓溶解裝置，將溶栓藥物直接輸送至凝塊。這些藥物有助於溶解血栓並恢復血液流動。 DVT、PE 和其他疾病經常以導管溶栓治療。動脈血栓、肺栓塞和深部靜脈血栓等血管疾病的盛行率呈上升趨勢，增加了對血栓管理設備的需求。

醫療技術的不斷發展使得開發更有效率、微創的血栓管理工具成為可能，從而改善患者的治療效果並加速康復。

動力學

FDA 核准

例如，2023 年 1 月，專注於尖端藥物的全球醫療保健公司 Penumbra, Inc. 報告稱，市場上最先進、最有效的機械血栓切除系統 Lightning Flash 已獲得美國食品和藥物管理局批准使用管理（FDA ）。 Lightning Flash 中採用了 Penumbra 創新的 Lightning 智慧抽吸技術和雙凝塊偵測演算法。 Lightning Flash 旨在結合尖端導管工程，快速清除體內大血栓，例如靜脈血栓和肺栓塞 (PE)。

由 Penumbra ENGINE 驅動的 Lightning Flash 使用基於壓力和流量的演算法來識別血栓和血流。用於製造 Lightning Flash 導管的 MaxID 海波管技術可實現與大口徑導管相當的內徑，同時保持低調和柔軟、無創傷的尖端，旨在幫助導航身體複雜而精緻的結構。該設備的組合使用旨在促進快速清除血塊，同時限制潛在的失血。

活躍的主要參與者

2023年3月，在印度國內一些地區，SMT表示已被選為Penumbra外周和冠狀血管取栓技術的獨家經銷商。根據合約條款，SMT 將向醫療保健提供者提供 Penumbra 最新的 Indigo 系統產品組合，包括最近獲得印度中央藥品標準控制組織批准的 CATTM RX 以及經監管部門批准後用於治療冠心病等疾病的 Lightning 技術血栓形成、靜脈血栓、動脈血栓和肺栓塞。

憑藉閃電抽吸管，Penumbra 的 Indigo 系統產品組合是第一個也是唯一一個可以區分凝塊和血液、減少失血的電腦輔助機械抽吸技術。它設計用於單次清除週邊動脈和靜脈系統中的血塊，包括治療肺栓塞。此外，Penumbra 的 Indigo System CAT RX 能夠安全有效地清除冠狀動脈和周邊動脈中的血栓。

加強關鍵參與者之間的合作

2023年6月，智慧醫療器材領域領導者Sensome與全球導絲產業領導者Asahi Intecc強力聯手，打造新一代Clotild智慧導絲。 Asahi Intecc 將負責製造這種用於治療急性缺血性中風的突破性設備。

後天性長期殘疾最常見的原因是腦缺血性中風，可以透過機械血栓切除術來治療。此手術使用血栓切除工具，沿著導線從手腕或腹股溝引導到阻塞部位，以去除阻塞大腦動脈的血栓。輕鬆快速去除血栓，顯著改善患者的治療效果。

心血管疾病盛行率增加

據世界衛生組織稱，每年有 1790 萬人死亡，心血管疾病 (CVD) 是全球死亡的主要原因。冠心病、腦血管疾病、風濕性心臟病和其他疾病都屬於心臟和血管疾病（CVD）的範疇。每 5 例 CVD 死亡中就有超過 4 例是由心臟病發作和中風造成的，其中三分之一的死亡發生在 70 歲之前。

根據發表在《美國心臟病學會雜誌》上的一項研究，預計到2060 年，美國心血管危險因子和疾病的發病率將大幅上升。心血管趨勢的顯著上升可能會給人們帶來更大的壓力。美國的醫療保健系統強調需要公平地獲得早期疾病預防服務，包括教育和治療。

設備成本高

深入的工程、研究和臨床測試對於創造新的醫療設備都是必要的，並且它們都增加了將產品推向市場的整體價格。製造商必須花錢進行徹底的測試和文書工作，以遵守嚴格的安全性和有效性監管標準，這增加了成本。

醫療器材經常需要符合嚴格的無菌、耐用性和生物相容性要求的專用材料。獲取和處理這些資源的成本可能很高。使用尖端技術生產複雜的醫療器材可能需要複雜的製造程序、訓練有素的人員和品質控管程序。

技術課題

在創建具有複雜設計和功能的醫療設備時，確保所有組件一起正常運作可能會出現技術困難。確保與當前醫療工具、實踐和工作流程的兼容性可能很困難，特別是在將新設備合併到成熟的基礎設施中時。

為了安全有效地使用設備，必須為醫護人員設計使用者友善、直覺的介面。複雜的循環系統必須透過導管進行導航，同時限制對周圍組織的傷害，這需要專業知識和高科技成像指導。

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