Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)

This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for at least 14 days and no more than 60 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.

开始日期2022-08-08

申办/合作机构

Mercator MedSystems, Inc.

NCT04862468 / Active, not recruiting临床2期

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT (DEXTERITY-AFP)

This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for up to 14 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.

开始日期2021-10-29

申办/合作机构

Mercator MedSystems, Inc.

NCT04433572 / Not yet recruiting临床3期

Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the Incidence of Ischemia-Driven Major Amputation, Clinically Driven Target Lesion Revascularization, and Clinically Relevant Target Lesion Occlusion After Revascularization of Lesions Below the Knee in Patients With Symptomatic Rutherford 3-5 Peripheral Artery Disease

A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion revascularization, and clinically relevant target lesion occlusion after revascularization of lesions below the knee in patients with symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.

开始日期2020-12-01

申办/合作机构

Mercator MedSystems, Inc.

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2022-12-01·Cardiovascular revascularization medicine : including molecular interventions

One-Year Follow-Up of Vascular Intervention Trials Disrupted by the COVID-19 Pandemic: A Use-Case landscape

Article

作者: Barakat, Mark K ; Kirtane, Ajay J ; Krucoff, Mitchell W ; Farb, Andrew ; Malone, Misti ; Rymer, Jennifer A ; Jaff, Michael R ; Stephens, Dan ; Seward, Kirk

INTRODUCTION:

The COVID-19 pandemic had an unprecedented impact on cardiovascular clinical research. The decision-making and state of study operations in cardiovascular trials 1-year after interruption has not been previously described.

METHODS:

In the spring of 2020, we created a pandemic impact task force to develop a landscape of use case scenarios from 17 device trials of peripheral artery disease (PAD) and coronary artery disease (CAD) interventions. In conjunction with publicly available (clinictrials.gov) study inclusion criteria, primary endpoints and study design, information was shared for this use-case landscape by trial leadership and data owners.

RESULTS:

A total of 17 actively enrolling trials (9 CAD and 8 PAD) volunteered to populate the use case landscape. All 17 were multicenter studies (12 in North America and 5 international). Fifteen studies were industry-sponsored, of which 13 were FDA approved IDEs, one was PCORI-sponsored and two were sponsored by the NIH. Enrollment targets ranged from 150 to 9000 pts. At the time of interruption, 5 trials were <20 % enrolled, 9 trials were 50-80 % enrolled and 3 trials were >80 % enrolled. At 1 year, the majority of studies were continuing to enroll in the context of more sporadic but ongoing pandemic activity.

CONCLUSIONS:

At 1 year from the first surge interruptions, most trials had resumed enrollment. Trials most heavily interrupted were trials early in enrollment and those trials not able to pivot to virtual patient and site visits. Further work is needed to determine the overall impact on vascular intervention trials disrupted during the COVID-19 pandemic.

2019-09-01·Chest1区 · 医学

Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy

1区 · 医学

Article

作者: Mallow, Christopher ; Seward, Kirk ; Akulian, Jason ; Yarmus, Lonny ; Wahidi, Momen M ; Ettinger, David ; Voong, Kinh Ranh ; Lin, Cheng Ting ; Hales, Russell ; Feller-Kopman, David ; Semaan, Roy ; Lee, Hans

BACKGROUND:

Malignant airway obstruction (MAO) occurs in 30% of patients with advanced-stage lung cancer, leading to debilitating dyspnea, cough, and hemoptysis. Other than recanalization of the airways, these patients lack long-lasting palliative therapy. The goal of this study was to determine the safety and feasibility of local injection of paclitaxel into the airway wall with a novel microinjection catheter.

METHODS:

In this multicentered prospective trial, 23 patients with non-small cell lung cancer and MAO were enrolled from July 2014 through June 2016 to undergo rigid bronchoscopy with recanalization, followed by injection of 1.5 mg of paclitaxel with a novel injection catheter. Primary end points consisted of safety (adverse events, severe adverse events, and unanticipated adverse device effects) as well as feasibility (number of injections, injection success). Secondary end points consisted of airway patency improvement, quality of life metrics, and need for further interventions and/or stenting.

RESULTS:

Nineteen patients underwent rigid bronchoscopy with successful recanalization and paclitaxel injection. There were no adverse events, severe adverse events, or unanticipated adverse device effects. There was an average of 3.4 injections given for a total dose of 1.5 mg of paclitaxel in all patients. There was significantly less stenosis postprocedure vs preprocedure (25%-50% vs 75%-90%; P < .001), which was unchanged at 6 weeks (25%-50%). None of the participants required further interventions or airway stenting.

CONCLUSIONS:

The injection of paclitaxel after recanalization of MAO in patients with non-small cell lung cancer is safe and feasible, using a novel airway injection device.

TRIAL REGISTRY:

ClinicalTrials.gov; No.: NCT02066103; URL: www.clinicaltrials.gov.

Tech transfer from the eye of an investor

作者: Loarie, Thomas M.

Tom Loarie will speak on his technol. transfer experiences with Silicon BioDevices and Mercator MedSystems from the perspectives of a board member and investor.As he serves on the Dean′s Council, Jacobs School of Engineering at UC San Diego, and works with their new incubator, he will interject the role of the incubator in the tech transfer process.

项与 Mercator MedSystems, Inc. 相关的新闻（医药）

2023-10-30

·PRNewswire

Late-Breaking Clinical Trial Results Announced at The VEINS 2023

LAS VEGAS, Oct. 30, 2023 /PRNewswire/ -- The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the Late-Breaking Clinical Trials session at The VEINS conference, hosted at Wynn Las Vegas. The VEINS (Venous Endovascular INterventional Strategies) is an annual venous education symposium that brings together a global, multispecialty faculty to present a comprehensive variety of talks and case presentations focused on venous care. Attendees include an audience of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of this morning's 4 late-breaking clinical trial presentations. 1-Year Clinical Outcomes of Deep Vein Thrombosis Patients Treated With Mechanical Thrombectomy: Analysis of the CLOUT Registry Presented by David J. Dexter, MD Long-term, prospective outcome data after mechanical thrombectomy (MT) for deep vein thrombosis (DVT) are lacking. The CLOUT (ClotTriever Outcomes) registry is a prospective, multicenter study evaluating patient outcomes for proximal lower extremity DVT treated with the ClotTriever system (Inari Medical). CLOUT is the largest MT study in the field of DVT, and although positive results have been previously published, this is the first report of 1-year outcomes for all available patients. Patients in CLOUT were aged ≥ 18 years and enrolled regardless of bilateral disease, duration of symptoms, prior treatment failure for the current DVT event, or contraindications to thrombolytic therapy. A total of 310 patients completed the 1-year follow-up visit. One year after MT, moderate-to-severe postthrombotic syndrome (PTS; Villalta score ≥ 10) was observed in 8.8% of treated limbs. The overall PTS rate (Villalta score ≥ 5) was 19.3%. Venous patency, as measured by the presence of flow with normal or partial compressibility on duplex ultrasound, was observed in 94.2% of cases. Additionally, significant improvements from baseline in revised Venous Clinical Severity Score, Numeric Pain Rating Scale score, and EQ-5D questionnaire score were demonstrated. In the real-world, all-comer CLOUT registry, 1-year outcomes demonstrate a low rate of PTS following treatment with the ClotTriever system, which was complemented by patient-centric improvements in symptom relief and quality of life. Study follow-up through 2 years is ongoing. These favorable clinical outcomes highlight the need for randomized controlled trial data comparing MT with standard of care anticoagulation treatment. The recently initiated randomized controlled DEFIANCE trial (NCT05701917) will compare the ClotTriever system to anticoagulation for the treatment of symptomatic iliofemoral DVT. Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System: The VIVID Trial Presented by: Mahmood Razavi, MD The Duo Venous Stent System, comprised of the Duo Hybrid and Duo Extend stents, is uniquely designed for the varying anatomical and mechanical demands of the iliofemoral venous segment. The purpose of the VIVID study was to investigate the safety and efficacy of the Duo Venous Stent System for the treatment of patients with non-malignant iliofemoral occlusive disease. VIVID was a prospective, multi-center, single-arm study conducted in the United States and Poland. Study centers enrolled patients with non-thrombotic, acute thrombotic, or chronic post-thrombotic clinically significant venous outflow obstruction. Patients were required to have at least one of the following clinical indicators: CEAP ³3, VCSS pain score ³2, and/or suspected and symptomatic deep vein thrombosis. Performance goals were established from published, peer reviewed scientific literature. The primary safety endpoint was freedom from major adverse events at 30 days post-index procedure. The primary efficacy endpoint was primary patency of the stented segment at 12 months. The primary efficacy performance goal was derived based on enrollment distribution within the three disease states. Primary endpoints were adjudicated by a clinical events committee and/or core laboratory. Secondary and observational endpoints include symptom relief, primary-assisted patency, secondary-assisted patency, and device success. Patients remain in follow-up through 36 months. The VIVID trial enrolled 162 patients at 30 sites between 2020 and 2021. Primary safety and efficacy endpoints were met and will be available for presentation at the VIVA/VEINS meeting. First-in-Human: Safety and Performance of the Akura Medical Thrombectomy System in Treating Venous Thromboembolism Presented by: Jay Mathews, MD, MS A first-in-human, prospective, single-arm study enrolled five patients at two sites in Tbilisi, Georgia, in March and April 2023 to evaluate the safety and performance of percutaneous mechanical thrombectomy using the Akura Medical Thrombectomy System (Akura Medical). The Akura system is a low-profile system that combines targeted clot removal with a platform capable of providing objective data on hemodynamics to help clinicians understand the relationship between thrombus removal and alleviation of pulmonary artery pressures. The key inclusion criteria included medically eligible patients aged > 18 years with clinical symptoms consistent with acute pulmonary embolism (PE) or sPESI (simplified PE Severity Index) ≥ 1, with symptom onset ≤ 14 days, proximal PE confirmed by CTA, a stable heart rate < 130 bpm prior to procedure, and systolic blood pressure ≥ 90 mm Hg, with a right ventricular/left ventricular (RV/LV) ratio > 0.9. Five patients were enrolled, treated, and followed through 7-day follow-up. The patients successfully received treatment with the Akura thrombectomy system to remove pulmonary thrombus in the pulmonary vasculature. The average procedure time from anesthesia start to closure was 117 ± 50 minutes, with an average fluoroscopy time of 30 ± 21 minutes (range, 13-68 minutes). Total blood loss was 247 ± 80 mL on average, with 189 ± 120 mL of contrast used per procedure. After 48 hours, the RV/LV ratio decreased by 0.35 from 1.29 ± 0.15 to 0.94 ± 0.12 (P < .05; 26.85% reduction). Through 7-day follow-up, there were no deaths, device-related major bleeding, or device-related adverse events. The Akura thrombectomy system for PE appears safe, and preliminary evidence shows that this platform technology leads to a significant reduction in RV/LV ratio and thrombus burden. Local Anti-Inflammation to Augment Deep Vein Thrombosis Intervention: 6-Month Results From the Open-Label Phase of the DEXTERITY-AFP Trial Presented by: David J. Dexter, MD The DEXTERITY-AFP trial is a phase 2, multisite trial investigating Bullfrog microinfusion device (Mercator MedSystems, Inc.) perivenous injection of dexamethasone sodium phosphate injection, USP combined with contrast and at a dosage of 2 mL (6.4 mg) each 5 cm of treatment length to improve patency and postthrombotic syndrome (PTS) 6 months after thrombus removal in symptomatic deep vein thrombosis (DVT) spanning into at least the common femoral, femoral, and/or popliteal veins. In the first phase of the trial, 21 participants were enrolled and treated with dexamethasone for comparison to known historical data. In the second phase of the trial, 60 participants will be enrolled 1:1 in a dual-blinded, randomized controlled trial (RCT). DEXTERITY-AFP is the first known trial to investigate local drug delivery intended to reduce venous inflammation associated with DVT. Of the 21 patients enrolled in the first phase of the trial, one patient withdrew after 1-month follow-up. The 20 patients remaining are 90% male, 60% have left-sided DVT, are 10.2 ± 0.7 days post–symptom onset, and average treatment length is 36 ± 2 cm. Thrombus extent was categorized as 75% iliofemoral and 25% femoropopliteal. Regarding safety, there were no Bullfrog (device)- or dexamethasone (drug)-related serious adverse events observed. The primary efficacy endpoint, clinically relevant loss of primary patency, will be examined as combined with the RCT phase. Of the 21 patients followed at 1 month, 19 (90.5%) had fully compressible and two had partially compressible common femoral veins. Other key secondary endpoint data for 20 participants with in-window, 6-month follow-up include reduction from baseline to 6 months in average Villalta score (7.3 ± 0.7 to 1.6 ± 0.4) and 10-point pain score (3.2 ± 0.7 to 0.5 ± 0.2). Mild PTS was observed in 1/20 (5.0%) patients with no moderate-severe PTS. About the VIVA Foundation The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about the VIVA Foundation, visit . SOURCE The VIVA Foundation

临床结果临床2期

2022-06-17

·PRNewswire

The Worldwide Renal Denervation Industry is Expected to Reach $1.4 Billion by 2028

DUBLIN, June 17, 2022 /PRNewswire/ -- The "Global Renal Denervation Market Size, Share & Industry Trends Analysis Report By Technology (Radiofrequency, Ultrasound, and Micro-Infusion), By End User, By Product Type By Regional Outlook and Forecast, 2022 - 2028" report has been added to ResearchAndMarkets.com's offering. The Global Renal Denervation Market size is expected to reach $1.4 billion by 2028, rising at a market growth of 36.4% CAGR during the forecast period. Renal denervation is a minimally invasive, catheter-based treatment for hypertension. The nerves in the renal arteries are burnt using radiofrequency ablation. Nerve activity is lowered, and blood pressure is reduced. When pharmacological treatment has failed to provide relief, this procedure is usually employed in order to obtain enhanced results. The nerves of the renal artery wall are ablated using radiofrequency pulses or ultrasound. This reduces blood pressure by lowering sympathetic kidney activity. One of the key factors supporting Market growth is a significant rising prevalence of lifestyle diseases, like hypertension, due to an increase in the number of people who smoke and drink alcohol, sedentary and hectic lifestyles, increasing unhealthy dietary patterns, and the surging geriatric population. Apart from that, the RDN system's advantages, such as quick recuperation, safety, efficiency, and cost-effectiveness, are operating as a major growth-inducing element. Moreover, the rising demand for minimally invasive surgeries is fueling the Market 's expansion. In addition, micro-infusion technology, improved healthcare infrastructure, increased research and development activities, and an increase in the number of files for regulatory approvals of the systems are all contributing to Market expansion. Ultrasound ablates nerves in the renal artery wall, interrupting nerve impulse transmission and decreasing blood pressure with ultrasound-based renal denervation devices. It is a hypertension treatment that is done with the least amount of invasiveness possible. Ultrasound-based technologies" significant efficacy in trials is anticipated to rise their relevance and rejuvenate them. For example, ReCor Medical, a medical device manufacturer, debuted Paradise Ultrasound Renal Denervation for the therapeutics of hypertension in October 2021. This minimally invasive renal denervation technology is used to treat excessive blood pressure. Hence, the significant number of benefits of this method along with the increasing efforts and initiatives being introduced by major Market players is expected to accelerate the growth of the renal denervation Market throughout the coming years. COVID-19 Impact Analysis The COVID-19 pandemic caused a severe impact on various economies all over the world. Several businesses were significantly devastated as a result of the outbreak of the COVID-19 infection. In addition, the governments of several countries were forced to impose lockdowns in their nations. As a result, the manufacturing units of numerous goods were temporarily shut down. Moreover, these lockdowns also caused a major disruption in the supply chain of various goods. Further, COVID-19 led the worldwide healthcare industry to a significant failure due to the shortage of beds and oxygen in hospitals. Market Growth Factors Rising instances of hypertension among people With the increasing modernization all over the world, the lifestyles of people are majorly being altered. The day-to-day routines of people worldwide are increasingly becoming hectic. Hypertension is a significant and modifiable risk factor for cardiovascular disorders and diseases, chronic kidney disease, and death. Because more strict BP objectives are recommended by guidelines, obtaining these targets frequently necessitates the use of multiple drugs, which can result in increased dosing complexity, expense, pill burden, and drug intolerance. There are few choices for treating hypertension without worsening polypharmacy or in the presence of multidrug intolerance. Introduction of new capabilities in Renal Denervation The number of new capabilities that are being introduced in the renal denervation approach is one of the major factors that is accelerating its adoption. Renal denervation systems that incorporate ultrasound technology can overcome the limitations of radiofrequency-based renal denervation systems. The high-frequency sound waves of the ultrasonic energy aid to ablate nerves without coming into close touch with the tissues. This aids in the prevention of renal artery damage. Due to this attribute, a significant number of patients all over the world prefer this technology. Moreover, the integration of technology into these kinds of healthcare practices offers a considerable scale of enhancements in the outcomes of these techniques. Market Restraining Factors Risk of post-surgery infection One of the major factors that are restricting the demand for renal denervation methods is the risk of infection that can be caused post a surgery. Any kind of surgery that involves cuts, incisions, or any other kind of invasion into the skin can cause infection in the body of the patient. Mostly, infections in surgical wounds are visible after one month of the surgery. Due to the post-surgical infection, various types of problems in the wound or in the body of the patient can occur. For example, surgical wound infections can ejaculate the puss from the incision. In addition, these infections are very painful and cause soars and inflammation in the wound. Key Topics Covered: Chapter 1. Market Scope & Methodology Chapter 2. Market Overview 2.1 Introduction 2.1.1 Overview 2.1.1.1 Market Composition and Scenario 2.2 Key Factors Impacting the Market 2.2.1 Market Drivers 2.2.2 Market Restraints Chapter 3. Global Renal Denervation Market by Technology 3.1 Global Radiofrequency Market by Region 3.2 Global Ultrasound Market by Region 3.3 Global Micro-Infusion Market by Region Chapter 4. Global Renal Denervation Market by End User 4.1 Global Hospitals Market by Region 4.2 Global Specialty Clinics Market by Region 4.3 Global Others Market by Region Chapter 5. Global Renal Denervation Market by Product Type 5.1 Global Symplicity Market by Region 5.2 Global Enlightn Market by Region 5.3 Global Vessix Market by Region 5.4 Global Paradise Market by Region 5.5 Global Iberis Market by Region 5.6 Global Others Market by Region Chapter 6. Global Renal Denervation Market by Region Chapter 7. Company Profiles 7.1 Abbott Laboratories 7.1.1 Company Overview 7.1.2 Financial Analysis 7.1.3 Segmental and Regional Analysis 7.1.4 Research & Development Expense 7.2 Boston Scientific Corporation 7.2.1 Company Overview 7.2.2 Financial Analysis 7.2.3 Segmental and Regional Analysis 7.2.4 Research & Development Expense 7.3 Medtronic PLC 7.3.1 Company overview 7.3.2 Financial Analysis 7.3.3 Segmental and Regional Analysis 7.3.4 Research & Development Expenses 7.3.5 Recent strategies and developments: 7.3.5.1 Partnerships, Collaborations, and Agreements: 7.4 Ablative Solutions, Inc. 7.4.1 Company Overview 7.5 Mercator MedSystems, Inc. 7.5.1 Company Overview 7.6 ReCor Medical, Inc (Otsuka Holdings Co., Ltd.) 7.6.1 Company Overview 7.6.2 Financial Analysis 7.6.3 Segmental and Regional Analysis 7.6.4 Research & Development Expenses 7.6.5 Recent strategies and developments: 7.6.5.1 Product Launches and Product Expansions: 7.7 Renal Dynamics Limited 7.7.1 Company Overview 7.8 Johnson & Johnson 7.8.1 Company Overview 7.8.2 Financial Analysis 7.8.3 Segmental &Regional Analysis 7.8.4 Research & Development Expenses 7.8.5 Recent strategies and developments: 7.8.5.1 Partnerships, Collaborations and Agreements: 7.9 Terumo Corporation 7.9.1 Company Overview 7.9.2 Financial Analysis 7.9.3 Segmental Analysis 7.9.4 Recent strategies and developments: 7.9.4.1 Acquisition and Mergers: For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets

并购合作

2022-06-07

·PRNewswire

Critical Limb Ischemia Market to Progress at a CAGR of 10.6% by 2030 | DelveInsight

The critical limb ischemia market is expected to expand with a rise in prevalence and the expected entry of emerging therapies into the 7MM markets. LAS VEGAS, June 7, 2022 /PRNewswire/ -- DelveInsight's critical limb ischemia market insights report includes a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2018 to 2030, segmented into 7MM (the United States, the EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. Key Takeaways from the Critical Limb Ischemia Market According to DelveInsight estimates, the Critical Limb Ischemia market size in the 7MM was USD 1,519 million in 2020. As per analysis, the total critical limb ischemia diagnosed prevalent population in the 7MM was approximately 2 million in 2020. Key critical limb ischemia companies such as Boston Scientific Corporation, AnGes, Inc., Mitsubishi Tanabe Pharma, B. Braun Melsungen AG, Medtronic Endovascular, Ixaka Ltd (formerly Rexgenero), Mercator MedSystems, Inc, Hemostemix Inc., Caladrius Biosciences, Reven Pharmaceuticals, Inc., New Beta Innovation Limited, BioGenCell Ltd., Abbott Medical Devices, and others are developing novel drugs and technologies/devices, which can be available in the critical limb ischemia market in the upcoming years. The critical limb ischemia therapies/technologies/devices in the pipeline include REX-001, Temsirolimus Adventitial Delivery, Collategene, ACP-01, Honedra (CLBS12), RJX (Rejuveinix), YQ23, BGC101, Esprit BTK Device , and others. The increase in the critical limb ischemia market size directly impacts the increasing prevalent population of critical limb ischemia patients in the 7MM. Discover more about therapies that are set to grab major critical limb ischemia market share at critical limb ischemia market landscape Critical Limb Ischemia Critical limb ischemia is a clinical syndrome characterized by ischemic pain at rest and tissue loss, such as nonhealing ulcers or gangrene, caused by lower limb peripheral arterial disease (PAD). Critical limb ischemia is the final stage of PAD, and macrovascular lesions cause a decrease in distal perfusion. This disease drastically impairs nutrient blood flow to tissues and microcirculation exchange. Rutherford has traditionally characterized critical limb ischemia as rest pain (class 4), tissue loss (class 5), and gangrene (class 6). Rest discomfort is classified as class 3 in the Fontaine classification, and tissue loss or gangrene is classified as class 4 in the Fontaine classification. The threatened critical limb ischemia classification system was recently developed by the Society for Vascular Surgery Lower Extremity Guidelines Committee: Risk stratification based on wound, ischemia, and foot infection (WIfI). The critical limb ischemia life expectancy is around 1.23 years for men and 2.7 years for women. The most noticeable critical limb ischemia symptoms are ischemic rest pain — extreme pain in the legs and feet when a person is not moving or nonhealing sores on the feet or legs. Other critical limb ischemia symptoms include an absent or decreased pulse in the legs or feet, open sores, skin infections or nonhealing ulcers, toenail thickening, dry gangrene, shiny, smooth, dry skin of the legs or feet, and pain or numbness in the feet; other factors such as age, smoking, diabetes, high cholesterol, family history, etc. also contribute. Physical examination and noninvasive hemodynamic testing (ankle-brachial index [ABI]/ankle pressure [AP], toe-brachial index [TBI]/toe pressure [TP], imaging of vascular anatomy, duplex ultrasound imaging [DUS], computed tomography angiography [CTA], and others) can be used for critical limb ischemia diagnosis. Critical Limb Ischemia Epidemiology Segmentation In 2020, approximately 2 million critical limb ischemia diagnosed prevalent population was affected in the 7MM. Among EU5 countries, Germany had the highest critical limb ischemia diagnosed prevalence in 2020. The critical limb ischemia market report offers epidemiological analysis for the study period 2018–2030 in the 7MM segmented into: Total diagnosed prevalent cases of critical limb ischemia Age-specific diagnosed prevalent cases of critical limb ischemia Severity-specific diagnosed prevalent cases of critical limb ischemia Diagnosed prevalent cases of no-option critical limb ischemia Download the report to understand which factors are driving critical limb ischemia epidemiology trends at critical limb ischemia epidemiological insights Critical Limb Ischemia Treatment Market The basic aim of Critical Limb Ischemia treatment is pain relief, trophic lesion healing, avoiding high-level amputations, improving limb functionality and quality of life, and improving medium-term survival. These objectives call for an interdisciplinary approach. Revascularization is the most common and effective critical limb ischemia treatment option. Other approaches include the administration of analgesics, the treatment of infections, and the optimization of cardiac and pulmonary function. Patients with critical limb ischemia require monitoring and therapy for cardiovascular risk factors as much as any other patient with PAD. When revascularizing operations are not possible or have proven unsuccessful, prostanoids are utilized. Cell and gene therapies are gaining popularity as critical limb ischemia treatments for patients ineligible for endovascular or surgical revascularization. Several regeneration treatments, including angiogenic recombinant proteins, gene therapy, cell-based therapies (including stem or progenitor cells), and chemokines, have been studied in patients with PAD and nonrevascularizable critical limb ischemia. Collategene (HGF plasmid) is the only approved critical limb ischemia treatment in Japan. The company also intends to penetrate the US critical limb ischemia market. Furthermore, many cell therapies are being developed to target the population that is not appropriate for revascularization or has poor results following revascularization. To know about more Critical Limb Ischemia management, visit at critical limb ischemia guidelines Critical Limb Ischemia Pipeline Therapies/Technologies/Devices and Key Companies REX-001: Ixaka Ltd (formerly Rexgenero) Temsirolimus Adventitial Delivery: Mercator MedSystems, Inc. Collategene: Anges and Mitsubishi Tanabe Pharma ACP-01: Hemostemix Inc. Honedra (CLBS12): Caladrius Biosciences RJX (Rejuveinix): Reven Pharmaceuticals, Inc. YQ23: New Beta Innovation Limited BGC101: BioGenCell Ltd. Esprit BTK Device: Abbott Medical Devices Critical Limb Ischemia Market Dynamics The rising prevalence of diabetes due to an aging global population will boost the critical limb ischemia treatment options, resulting in critical limb ischemia market growth. Moreover, companies are actively developing critical limb ischemia drugs to address the disease's unmet requirements, despite the disease's low visibility and complexity. Except in Japan, there are no authorized pharmaceutical critical limb ischemia treatment alternatives, creating tremendous potential for investment and research for innovative drugs along with less competition. The present unmet need of the critical limb ischemia market is medications that are safer and more effective in providing an optimal cure. However, some factors restrain the critical limb ischemia market growth. The disease is being underdiagnosed and undertreated, resulting in greater morbidity, death, and costs. L ack of awareness and other similar diseases challenge the critical limb ischemia market's growth. Pricing and reimbursement rules that are strictly enforced also limit the growth of the critical limb ischemia market along with the failure of drugs in clinical development. Moreover, the availability of surgical procedures may make it difficult for innovative treatments to get a foothold. Scope of the Critical Limb Ischemia Market Report Study Period: 2018–2030 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Critical Limb Ischemia Companies: Boston Scientific Corporation , AnGes, Inc, Mitsubishi Tanabe Pharma, B. Braun Melsungen AG, Medtronic Endovascular, Ixaka Ltd (formerly Rexgenero), Mercator MedSystems, Inc, Hemostemix Inc., Caladrius Biosciences, Reven Pharmaceuticals, Inc., New Beta Innovation Limited, BioGenCell Ltd., Abbott Medical Devices, and others Key Critical Limb Ischemia Therapies/Technologies/Devices: REX-001, Temsirolimus Adventitial Delivery, Collategene, ACP-01, Honedra (CLBS12), RJX (Rejuveinix), YQ23, BGC101, Esprit BTK Device, and others Therapeutic Assessment: Critical Limb Ischemia current marketed and emerging therapies Critical Limb Ischemia Market Dynamics: Critical Limb Ischemia market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Critical Limb Ischemia Market Access and Reimbursement Discover more about the future critical limb ischemia market share of treatment therapies at critical limb ischemia treatment market Table of Contents Get in touch with our Business executive at Healthcare Due Diligence Services Related Reports Critical Limb Ischemia Epidemiology Critical Limb Ischemia Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical, and forecasted critical limb ischemia epidemiology in the 7MM. Critical Limb Ischemia Pipeline Critical Limb Ischemia Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key critical limb ischemia companies involved are Pluristem Therapeutics, Reven Pharmaceuticals, Inc., New Beta Innovation Limited, among others. Critical Limb Ischemia Market Critical Limb Ischemia Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key companies such as Boston Scientific Corporation, AnGes, Inc, Mitsubishi Tanabe Pharma, B. Braun Melsungen AG, among others. Peripheral Arterial Disease Epidemiology Peripheral Arterial Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted peripheral arterial disease epidemiology in the 7MM. Peripheral Arterial Disease Pipeline Peripheral Arterial Disease Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products. The key companies are NovoNordisk, Takeda, Mercator MedSystems, Inc., among others. Peripheral Arterial Disease Market Peripheral Arterial Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, and market barriers. The key companies are NovoNordisk, Takeda, Mercator MedSystems, Inc., among others. Other Trending Reports Degenerative Disc Disease (DDD) Market "Degenerative Disc Disease (DDD) Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the degenerative disc disease market size, share, and trends in the 7MM. Some of the key companies in the degenerative disc disease market are DiscGenics, Kuros Biosciences, Mesoblast, Ankasa Therapeutics, and others. Periodontal Disease Market "Periodontal Disease Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the periodontal disease market size, share, and trends in the 7MM. Some of the key companies in the periodontal disease market are D and D Pharmatech, Amyndas Pharmaceuticals, AngioLab, Denteric, Dexcel Pharma Technologies, Yuhan Corporation, and others. IgG4-related Disease Market "IgG4-Related Disease Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the IgG4-related disease market size, share, and trends in 7MM. Some of the key companies in the IgG4-related disease market are Bristol-Myers Squibb, Xencor, Principia Biopharma, Viela Bio, Horizon Therapeutics, and others. Nicotine Addiction Market "Nicotine Addiction Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the nicotine addiction market size, share, and trends in the 7MM. Some of the key companies in the nicotine addiction therapeutics market include Axsome Therapeutics, Achieve Life Sciences, Novo Nordisk, and others. Hairy Cell Leukemia (HCL) Market "Hairy Cell Leukemia (HCL) Market" report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the hairy cell leukemia (HCL) market size, share, and trends in the 7MM. Some of the key companies in the hairy cell leukemia (HCL) therapeutics market include AstraZeneca, Janssen, Merck, Pharmacyclics, Johnson and Johnson, Roche, Innate Pharma, and others. Hypereosinophilic Syndrome Market "Hypereosinophilic Syndrome Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the hypereosinophilic syndrome market size, share, and trends in 7MM. Some key companies in the hypereosinophilic syndrome market include AstraZeneca, GlaxoSmithKline, Knopp Biosciences, and others. Related Healthcare Blogs Heart Failure Market Upcoming Cardiovascular Diseases Drugs Key Companies in the Cardiology Segment About DelveInsight DelveInsight is a leading business consultant and market research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 SOURCE DelveInsight Business Research, LLP

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