Transcatheter arterial chemoembolization

LimFlow Announces Agreement to Be Acquired by Inari Medical

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Mercoledì, Novembre 1, 2023
Cardiology, Radiology, Surgery, Health, FDA, Medical Devices, Clinical Trials, Other Health, Peripheral artery disease, Femoral vein, Chronic limb threatening ischemia, CLTI, MD, Acquisition, Sofinnova, Leg, Growth, The New England Journal of Medicine, Amputation, Transcatheter arterial chemoembolization, Pain, Patient, PAD, Wound healing, Pharmaceutical industry, Nursing

The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.

Key Points: 
  • The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.
  • "We are thrilled to join forces with Inari Medical, expanding the reach of our remarkable technology to bring renewed hope to patients who are currently suffering," said LimFlow CEO Dan Rose.
  • "Our heartfelt gratitude goes out to the exceptional LimFlow team, our dedicated clinical partners, and our investors who believed in our mission.
  • “The acquisition of LimFlow is closely aligned with our mission to address significant unmet patient needs and adds another highly differentiated growth platform into our portfolio,” said Drew Hykes, CEO of Inari.

M&L Healthcare's First MedTech Investment Receives FDA Approval Following Successful US Trials

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Lunedì, Settembre 18, 2023
Chin Na, Amputation, The New England Journal of Medicine, M&L, CE marking, Type 2 diabetes, Catheter, Johannes Hoffmann (vascular surgeon), Vein, Statistics, COVID-19, Clinical trial, Foot, Quality of life, St Luke's Hospital, Singapore, Leg, Artery, Changi General Hospital, Elective surgery, PMA, Transcatheter arterial chemoembolization, Patient, Investment, MD, Series, Engineering, Mortality, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medtech, Food, Wound healing, Pharmaceutical industry, Medical device, Valvulotome, EU, CLTI

The approval comes after successful outcomes in the PROMISE II Pivotal trial in the United States, recently published in the New England Journal of Medicine.

Key Points: 
  • The approval comes after successful outcomes in the PROMISE II Pivotal trial in the United States, recently published in the New England Journal of Medicine.
  • It is the first and only FDA-approved device for TADV and provides no-option CLTI patients with access to a minimally invasive treatment.
  • Type 2 diabetes is a major cause of CLTI, a condition that affects millions of people globally.
  • The United States alone witnesses approximately 150,000 ischemic amputations each year, resulting in healthcare costs of over US$95 billion.

FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options

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Martedì, Settembre 12, 2023
Health, FDA, Medical Devices, Diabetes, Surgery, Clinical Trials, Cardiology, Chronic limb threatening ischemia, The New England Journal of Medicine, Vein, Amputation, CE marking, PAD, Foot, Quality of life, Leg, Multimedia, Artery, Sale, Pain, Professor, Transcatheter arterial chemoembolization, MD, Patient, Risk, Peripheral artery disease, Mortality, CLTI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Wound healing, Pharmaceutical industry, Medical device

View the full release here: https://www.businesswire.com/news/home/20230908213065/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230908213065/en/
    The LimFlow System is designed to reestablish blood flow in deep veins for "no-option" patients with Chronic Limb-Threatening Ischemia (CLTI).
  • The technology bypasses permanently blocked arteries in the leg and foot and delivers oxygenated blood back into the foot via the veins.
  • (Graphic: Business Wire)
    The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is designed to reestablish blood flow in deep veins for “no-option” CLTI patients.
  • “We thank the FDA for their collaborative review process and we look forward to introducing and expanding use of the LimFlow System in the U.S.”
    The LimFlow System is indicated for patients who have chronic limb-threatening ischemia (CLTI) with no suitable endovascular or surgical revascularization options and are at risk of major amputation.

Landmark New England Journal of Medicine Publication Reports Positive Results From PROMISE II Pivotal Trial Showing that LimFlow System Saves Most Patients with End-stage Peripheral Artery Disease From Major Amputation

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Giovedì, Marzo 30, 2023
Health, FDA, Medical Devices, Surgery, General Health, Clinical Trials, Cardiology, Chin Na, Chronic limb threatening ischemia, The New England Journal of Medicine, Chronic kidney disease, Diabetes, Amputation, Rutherford, PAD, University Hospitals Cleveland Medical Center, Quality of life, Multimedia, Research, Doctor of Philosophy, Female, NEJM, Dialysis, DO, Professor, MD, Patient, Transcatheter arterial chemoembolization, Peripheral artery disease, Mortality, MPH, CLTI, Wound healing, Pharmaceutical industry, Medicine

The results demonstrated that the LimFlow System achieved 66% amputation-free survival (patients were alive and amputation-free) at six months.

Key Points: 
  • The results demonstrated that the LimFlow System achieved 66% amputation-free survival (patients were alive and amputation-free) at six months.
  • The therapy is designed to prevent amputation, which is associated with significant complications, mortality, and deterioration of quality of life.
  • PROMISE II was designed to be representative of a broad patient population, with 43% of subjects being Black, Hispanic, or Latino, and 31% female.
  • The no-option patients treated in PROMISE II were determined by an independent physician committee to be no longer eligible for conventional endovascular or surgical therapy to treat their CLTI.

Global Embolotherapy Market Analysis/Forecasts, 2022-2023 & 2029 - Growing Patient Population With Chronic Conditions Increasing the Demand for Embolization Procedures - ResearchAndMarkets.com

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Mercoledì, Febbraio 1, 2023
Health, Other Health, Hospital, Moyamoya disease, TACE, Urology, Microparticle, PVA, Transcatheter arterial chemoembolization, Neurology, TAE, Gelatin, Liver cancer, Arteriovenous malformation, Brachytherapy, Growth, Lung cancer, SIRT, Prevalence, Intracranial aneurysm, AVM, Video game, Speciality chemicals, Pharmaceutical industry, Nursing, Selective internal radiation therapy

The radioembolization segment is expected to grow at high single digit CAGR from 2022 to 2029.

Key Points: 
  • The radioembolization segment is expected to grow at high single digit CAGR from 2022 to 2029.
  • The liquid embolization agents market is expected to grow at early teens CAGR from 2022 to 2029.
  • Factors such as the growing patient population with chronic conditions increasing the demand for embolization procedures, and technology advancements are driving the market growth, whereas, acquisitions and collaborations and emerging markets are providing growth opportunities.
  • The Embolotherapy global market is a highly competitive market and all the existing players in this market are involved in developing new and advanced products to maintain their market shares.

NeoChord Announces Positive 1-year Follow-Up Data with Transcatheter NeXuS System for Mitral Chordal Repair Using Multiple Chords to a Single Anchor

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Mercoledì, Ottobre 19, 2022
Montefiore Medical Center, MR, Adrenal insufficiency, Hospital, Disease, LVEF, Heart, Transcatheter arterial chemoembolization, Patient, Cardiovascular disease, Interventional cardiology, EFS, Safety, GLOBE, Mitral valve, Solution, Pharmaceutical industry, Medical device, Medical imaging

Based on this clinical expertise, the Transcatheter NeXuS system has been developed to broaden patient access with a catheter-based approach.

Key Points: 
  • Based on this clinical expertise, the Transcatheter NeXuS system has been developed to broaden patient access with a catheter-based approach.
  • NeoChord announced today positive results on the first, 1-year follow up patient in the Companys Global Early Feasibility Study (EFS) treated with the novel Transcatheter NeXuS system.
  • The NeoChord NeXuS Transcatheter Mitral Chordal Repair device is unique from other mitral valve repair technologies in maintaining a natural physiologic functionality of the mitral valve.
  • NeoChord is now adding the minimally invasive transcatheter chordal repair system NeoChord NeXuS to its portfolio and is underlining the leading position in degenerative mitral valve chordal treatment.

EDWARDS ANNOUNCES SIX-MONTH DATA CONFIRMING TEER AS SAFE AND EFFECTIVE FOR DMR IN FIRST HEAD-TO-HEAD TRIAL

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Sabato, Settembre 17, 2022
Linda, Safety, Edwards Lifesciences, Quality of life, Alfieri, Critical care, U.S. Securities and Exchange Commission, Ventricular remodeling, MitraClip, Significance, CLASP, Drug Quality and Security Act, Annual report, DMR, View, YouTube, PASCAL, NYSE, MD, Quality, CE marking, News, Forward-looking statement, Instagram, Edwards, Security (finance), Transcatheter arterial chemoembolization, Mitral valve, Risk, Securities Exchange Act of 1934, Adrenal insufficiency, Twitter, LinkedIn, Securities Act of 1933, Stroke, Structural heart disease, Randomized controlled trial, Multimedia, University, TCT, Pharmaceutical industry, Medical imaging, Medical device, Patient, Facebook

The study confirms TEER as a safe and effective therapy in patients with degenerative mitral regurgitation (DMR).

Key Points: 
  • The study confirms TEER as a safe and effective therapy in patients with degenerative mitral regurgitation (DMR).
  • The PASCAL system further demonstrated significant and sustained MR 1+ with 83.7 percent of patients at MR 1+ at six months.
  • The CLASP IID trial is a prospective randomized controlled trial comparing the safety and effectiveness of the PASCAL system to the MitraClip system.
  • Edwards, Edwards Lifesciences, the stylized E logo, CLASP, Edwards PASCAL, Edwards PASCAL Precision, PASCAL, and PASCAL Precision are trademarks of Edwards Lifesciences Corporation.

The Worldwide Transcatheter Heart Valve Replacement Industry is Expected to Reach $11.8 Billion by 2027 - ResearchAndMarkets.com

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Lunedì, Febbraio 7, 2022
Health, Medical Devices, Cardiology, Prevalence, Percutaneous aortic valve replacement, Industry, Aortic valve, Government, TAVR, Medicare, Adrenal insufficiency, Stainless steel, Degenerative disease, Medicaid, Survival rate, Valvular heart disease, Heart, Cath lab, Risk, Hospital, Patient, Artery, American Heart Association, Cardiac arrest, Aortic stenosis, Acute decompensated heart failure, Transcatheter arterial chemoembolization, Physician, Infarction, Stroke, Insurance, Enlargement, Medical imaging

Over the past decade, transcatheter heart valve replacement has become the leading technique for aortic valve replacement, mitral valve replacement, and pulmonary valve replacement.

Key Points: 
  • Over the past decade, transcatheter heart valve replacement has become the leading technique for aortic valve replacement, mitral valve replacement, and pulmonary valve replacement.
  • Transcatheter heart valve replacement is a procedure with a less invasive approach that helps replace the heart valve with a prosthetic valve to treat severe aortic stenosis and mitral regurgitation.
  • Therefore, the growing cases of heart attacks, heart failures, strokes, and other heart-related conditions facilitate the market for transcatheter heart valve replacement.
  • On the basis of product, Transcatheter Heart Valve Replacement Market includes Transcatheter Aortic Vmeaningalve Replacement Market, Transcatheter Mitral Valve Replacement Market, and Transcatheter Pulmonary Valve Replacement Market.