Peripheral artery disease

Cardio Flow, Inc., Announces U.S. Food and Drug Administration (FDA) 510(k) Clearance for its FreedomFlow® Orbital Atherectomy Peripheral Platform

Retrieved on: 
Wednesday, October 18, 2023
Medical Devices, FDA, Health, Surgery, Other Health, Cardiology, Ascension St. Mary's Hospital, Peripheral artery disease, Artery, Incidence, Plaque, Food, Physician, Heel, Hip, Physics, Freedom, Ankle, Patient, Food and Drug Administration, Atherectomy, PAD, Hospital, Medical device, Powder metallurgy

Cardio Flow, Inc. , a privately held medical device company and developer of minimally invasive devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform.

Key Points: 
  • Cardio Flow, Inc. , a privately held medical device company and developer of minimally invasive devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform.
  • The simplicity of the FreedomFlow platform likewise offers time savings and cost efficiencies, with quick and simple device setup, no capital equipment, no lubricant, and reduced inventory needs.
  • Many of the existing atherectomy devices on the market have various design constraints and capital equipment costs.
  • We’re excited that FreedomFlow will now be available to physicians.”

Humacyte Publishes Preclinical Results Showing Human Acellular Vessel™ (HAV™) Patency as Modified Blalock–Taussig–Thomas Shunt in Juvenile Primate Model

Retrieved on: 
Monday, October 16, 2023
Patent, HAV, Buddha's hand, The Journal of Thoracic and Cardiovascular Surgery, Research, Nationwide, CABG, Heart, Tetralogy of Fallot, Hospital, FDA, Nationwide Children's Hospital, Regenerative medicine, National Center for Regenerative Medicine, Tetralogy, HUMA, Peripheral artery disease, Child, Patient, Sale, Pharmaceutical industry, Dentistry

The publication in the open-access Journal of Thoracic and Cardiovascular Surgery (JTCVS Open), entitled “ Evaluation of tissue-engineered human acellular vessels as a Blalock–Taussig–Thomas shunt in a juvenile primate model, ” describes a preclinical study in which researchers from Humacyte and Nationwide Children's Hospital (Columbus, OH) implanted 3.5mm diameter HAVs into a juvenile large-animal model of pediatric heart disease.

Key Points: 
  • The publication in the open-access Journal of Thoracic and Cardiovascular Surgery (JTCVS Open), entitled “ Evaluation of tissue-engineered human acellular vessels as a Blalock–Taussig–Thomas shunt in a juvenile primate model, ” describes a preclinical study in which researchers from Humacyte and Nationwide Children's Hospital (Columbus, OH) implanted 3.5mm diameter HAVs into a juvenile large-animal model of pediatric heart disease.
  • The study assessed the HAV’s patency, structure, and blood flow from one week to six months after the implant.
  • This study also demonstrates the successful extension of Humacyte’s manufacturing platform, from the production of 6.0mm vessels to 3.5mm vessels.
  • The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Cholesterol Tests Market: Identifying Elevated Cholesterol Levels Takes Center Stage in Global Healthcare - ResearchAndMarkets.com

Retrieved on: 
Tuesday, September 26, 2023
General Health, Health, Fitness & Nutrition, ASP, Prevalence, Stroke, Cholesterol, COVID-19, WHO model list of essential in vitro diagnostics, Splenic infarction, HDL, Market access, Hypertension, Market, SWOT, Blood, LDL, SWOT analysis, Peripheral artery disease, Total, Forecast, Pharmaceutical industry

This report is a leading authority in healthcare market analysis, presenting a comprehensive market model focusing on Cholesterol Tests.

Key Points: 
  • This report is a leading authority in healthcare market analysis, presenting a comprehensive market model focusing on Cholesterol Tests.
  • The Cholesterol Tests market is vital in identifying elevated cholesterol levels in the blood, which are associated with increased risks of heart attacks, strokes, and peripheral artery disease.
  • Cholesterol levels in the blood are determined through parameters such as High-Density Lipoproteins (HDL), Low-Density Lipoproteins (LDL), and total cholesterol.
  • The Cholesterol Tests model is segmented into the following categories:
    Key Inclusions of the Market Model:
    Detailed analysis of the impact of COVID-19 on the Cholesterol Tests market for 2020 and beyond.

Texas Vein and Wellness Institute Achieves Accreditation for Peripheral Arterial Intervention & Deep Venous from Intersocietal Accreditation Commission

Retrieved on: 
Tuesday, September 26, 2023
Medicine, Communication, Accreditation, IAC, Patient satisfaction, PAD, Quality of life, Trust, Clinical decision support system, Vein, Marketing, Comfort, Patient, Moyamoya disease, Peripheral artery disease, Diagnosis, Health, Mayo Clinic Center for Innovation, Environment, Safety, Nursing, Medical imaging, Medical device, Hospital

HOUSTON, Sept. 25, 2023 /PRNewswire/ -- Texas Vein & Wellness Institute (TXVWI), a leading provider of vein and vascular care in the Houston area, is proud to announce its recent accreditation for Peripheral Arterial Interventions and Deep Venous by the Intersocietal Accreditation Commission (IAC). TXVWI is the only facility in Houston to have achieved this prestigious accreditation, underscoring TXVWI's commitment to maintaining the highest standards of patient care, safety and excellence.

Key Points: 
  • HOUSTON, Sept. 25, 2023 /PRNewswire/ -- Texas Vein & Wellness Institute (TXVWI), a leading provider of vein and vascular care in the Houston area, is proud to announce its recent accreditation for Peripheral Arterial Interventions and Deep Venous by the Intersocietal Accreditation Commission (IAC).
  • The IAC Accreditations for Peripheral Arterial Interventions and Deep Venous are recognized as the benchmark for facilities in the field of vein and vascular care.
  • Dr. Rao emphasized the significance of this accreditation for both the institute and its patients:
    "IAC accreditation is a vital milestone for TXVWI as we continue to progress in the vein and vascular space.
  • Texas Vein & Wellness Institute is a premier vein and vascular center founded in 2013.

Alarming Increase in Cardiovascular Disorders Propels Growth in the 2023 Global Atherosclerosis Drugs Market - ResearchAndMarkets.com

Retrieved on: 
Monday, September 18, 2023
Pharmaceutical, Health, Cardiology, Blood pressure, Plaque, Obesity, Coronary artery disease, Pharmacy, Atherosclerosis, Splenic infarction, Market, Research, Artery, Inflammation, Aspirin, Peripheral artery disease, Government, Administration, Anticoagulant, Investment, Patient, Risk, ACE, Distribution, Route of administration, Growth, Diagnosis, R, Thrombus, Pharmaceutical industry

The global atherosclerosis drugs market, valued at $20.60 billion in 2022, is poised for substantial growth and is estimated to reach $27.71 billion by 2032, with a compound annual growth rate (CAGR) of 3% from 2023 to 2032.

Key Points: 
  • The global atherosclerosis drugs market, valued at $20.60 billion in 2022, is poised for substantial growth and is estimated to reach $27.71 billion by 2032, with a compound annual growth rate (CAGR) of 3% from 2023 to 2032.
  • Atherosclerosis drugs play a vital role in reducing plaque formation, managing cholesterol levels, reducing inflammation, preventing blood clots, and improving blood flow.
  • The growth of the global atherosclerosis drugs market is primarily driven by the alarming increase in cardiovascular disorders.
  • Additionally, the rising awareness of early diagnosis and treatment of atherosclerosis is boosting the demand for these drugs, positively impacting market growth.

Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma

Retrieved on: 
Tuesday, September 12, 2023
Infection, Biologics license application, KOL, Extremities, Surgeon, File, Amputation, Conference call, Internet, Ligation, Clinical trial, Trauma, Sale, Saphenous, Regenerative Medicine Advanced Therapy, Food and Drug Administration Amendments Act of 2007, Patient, Standard of care, Risk, HUMA, Injury, Peripheral artery disease, FDA, HAV, BLA, Conference, Food, Vaccine, Pharmaceutical industry

DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) --  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. The single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the Food and Drug Administration (FDA) during the 4th quarter of 2023.

Key Points: 
  • ET today -
    DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) --  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair.
  • Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the Food and Drug Administration (FDA) during the 4th quarter of 2023.
  • Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft.
  • Human Acellular Vessel (HAV) for Vascular Trauma Repair: Top Line Phase 2/3 V005 Results and KOL Perspectives

Results From Mayo Clinic Clinical Study of Humacyte’s Human Acellular Vessel™ (HAV™) in Treatment of Patients with Chronic Limb Ischemia Presented at Midwestern Vascular Conference

Retrieved on: 
Monday, September 11, 2023
Chin Na, Infection, Chronic limb threatening ischemia, Artery, Mayo Clinic, Surgeon, Human, Amputation, PAD, Food and Drug Administration, Sale, Trial of the century, Gangrene, Pain, Saphenous, Ischemia, Patient, Risk, HUMA, Peripheral artery disease, Clinical professor, Ulcer, FDA, HAV, Nerve, CLTI, Buddha's hand, Conference, Food, Disease, Pharmaceutical industry, Birth control

In the study the investigational HAV is being evaluated in patients with chronic limb-threatening ischemia (CLTI), the end stage of peripheral artery disease (PAD).

Key Points: 
  • In the study the investigational HAV is being evaluated in patients with chronic limb-threatening ischemia (CLTI), the end stage of peripheral artery disease (PAD).
  • The presentation at the Midwestern Vascular Conference in Minneapolis, MN, entitled Outcomes of Arterial Bypass Using the Human Acellular Vessel (HAV) In Patients With Chronic Limb Threatening Ischemia, concluded that in the clinical study the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage.
  • Of these 29 patients, 97% had previously experienced unsuccessful revascularization procedures on the extremity and 21 (72%) had tissue loss or gangrene.
  • The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

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

Retrieved on: 
Tuesday, September 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.

The Society for Vascular Surgery Launches National Initiative to Help Tobacco Users Quit

Retrieved on: 
Monday, August 21, 2023
Blood pressure, Smoker, SVS, Plaque, Society, Surgeon, Smoking, Non-Smokers' Rights Association, American Heart Association, Registry, Disability, Cholesterol, Cardiovascular disease, Cancer, Artery, Blood, PSO, Patient, Risk, Smoke, Peripheral artery disease, Heated tobacco product, Heart rate, Nicotine, Death, Patient safety organization, Social media, Safety, Nursing, Tobacco, Pharmaceutical industry, Dentistry

CAN-DO is part of the PSO's Vascular Quality Initiative (VQI) of the SVS.

Key Points: 
  • CAN-DO is part of the PSO's Vascular Quality Initiative (VQI) of the SVS.
  • The VQI mission is to improve the quality, safety, effectiveness and cost of vascular health care.
  • She and Lemmon noted that new technologies have multiplied the number of tools to help people quit.
  • "Most adults try to quit six times before being successful," said Wymer, and urged surgeons to stress, "It's never too late to quit."

Humacyte Presents Clinical Performance of Human Acellular Vessel™ (HAV™) From Ukrainian Humanitarian Program

Retrieved on: 
Tuesday, August 15, 2023
Amputation, Extremities, Surgeon, International, Life, Survival, Cell, Sale, Regenerative medicine, Ischemia, Hospital, Patient, HUMA, Love, Gunshot, Peripheral artery disease, Kharkiv, Sportspeople who died during their careers, FDA, HAV, Buddha's hand, BLA, Food, Pharmaceutical industry, Health

DURHAM, N.C., Aug. 15, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, presented yesterday at MHSRS the clinical results of a year-long humanitarian program in Ukraine. The Company’s investigational Human Acellular Vessel (HAV) was provided to five hospitals on the frontlines to treat traumatic vascular injuries beginning in June 2022.   

Key Points: 
  • The Company’s investigational Human Acellular Vessel (HAV) was provided to five hospitals on the frontlines to treat traumatic vascular injuries beginning in June 2022.
  • Humacyte’s humanitarian program was initiated in May 2022, when the company provided investigational HAVs to hospitals in Vinnytsia, Dnipro, Odessa, Kyiv, and Kharkiv, in response to Ukrainian surgeon requests.
  • Humacyte worked closely with the International Office of the U.S. Food and Drug Administration (FDA) and the Ukrainian Ministry of Health to obtain approval for the program.
  • Humacyte then subsequently trained Ukrainian surgeons by video conference on how to implant the HAV.