Peripheral artery disease

Wolters Kluwer delivers strong Lippincott journal performance in 2023 Journal Citation Reports

Retrieved on: 
Wednesday, August 9, 2023
Science, Software, Research, Publishing, General Health, Health, Communications, Technology, Learning, Sports medicine, Journal Citation Reports, Obstetrics, Circulation, Anesthesiology, American College of Sports Medicine, Hearing, ESCI, COVID-19, Jif, Wolters Kluwer, Testosterone and the cardiovascular system, Multimedia, Doctor of Philosophy, Impact factor, Wolters, Student, Patient, Transplant, Gynaecology, Clarivate, American College, Ear, Peripheral artery disease, JCR, Emerging Sources Citation Index, Lippincott, Pharmaceutical industry, Video game

Wolters Kluwer Health today announced strong results for the Lippincott portfolio of journals in the 2022 Journal Impact Factor (JIF), the journal metric released annually by Clarivate Analytics as part of the Journal Citation Reports (JCR).

Key Points: 
  • Wolters Kluwer Health today announced strong results for the Lippincott portfolio of journals in the 2022 Journal Impact Factor (JIF), the journal metric released annually by Clarivate Analytics as part of the Journal Citation Reports (JCR).
  • The 2023 rankings featured 387 Wolters Kluwer journals, with more than half (52%) receiving improved rankings from the previous year and an overall net increase for the portfolio.
  • To learn more about the titles within the Wolters Kluwer Lippincott publishing lineup, please visit lww.com .
  • The division of Wolters Kluwer supports clinical effectiveness, learning and research, clinical surveillance and compliance, as well as data solutions.

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon

Retrieved on: 
Monday, August 7, 2023
Senior, PAD, MCRA, DCB, Organization, Clinical trial, PMA, Peripheral artery disease, Biocompatibility, Quality assurance, FDA, Health, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Medical device, Computer security

The Surmodics team understood the importance of this collaboration, and we are honored to have played a part in this important PMA approval."

Key Points: 
  • The Surmodics team understood the importance of this collaboration, and we are honored to have played a part in this important PMA approval."
  • For Surmodics, we were able to integrate our biocompatibility expertise with our cardiovascular regulatory experience to create a successful outcome.
  • We thank Surmodics for trusting us to help them achieve their goals for the SurVeil™ drug-coated balloon."
  • Finally, our team enjoyed the spirit of camaraderie and candor in our working relationship with MCRA."

Humacyte Announces Publication of Biological Mechanism Explaining Low Rates of Infection Observed in Clinical Study of Human Acellular Vessel™ (HAV™)

Retrieved on: 
Thursday, August 3, 2023
Infection, Neutrophil, Amputation, Clinical trial, Quality of life, Sale, Sepsis, Dialysis, Polytetrafluoroethylene, Journal, Patient, HUMA, Peripheral artery disease, Vascular remodelling in the embryo, FDA, HAV, Trauma, Death, Pharmaceutical industry, Synthetic

DURHAM, N.C., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announces the publication of controlled in vitro studies in the Journal of Vascular Surgery – Vascular Science describing the scientific basis for the significantly lower rates of infection observed in a clinical trial of the investigational HAV compared to synthetic expanded polytetrafluoroethylene (ePTFE) grafts. The in vitro study results show the HAV had more host cell infiltration than ePTFE grafts, and that the biocompatibility of the HAV supported neutrophil viability and function, each of which may explain the HAV’s superior resistance to bacterial infection versus ePTFE grafts observed in the clinical trial. 

Key Points: 
  • Neutrophils are a critical cell type for host defense against infection.
  • Data analyzed from a comparative clinical trial demonstrated that the HAV had a significantly lower infection rate than ePTFE grafts.
  • A biological rationale for this finding was then shown through explant histopathology and cell experiments which demonstrated that the HAV, but not ePTFE grafts, supported neutrophil viability and function.
  • The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Alucent Biomedical Wins FDA Approval for U.S. Clinical Study

Retrieved on: 
Wednesday, August 2, 2023
Medical Devices, FDA, Health, Clinical Trials, Cardiology, Biotechnology, PAD, Trial of the century, Standard of care, Patient, Vascular disease, Coronary, Peripheral artery disease, Vascular remodelling in the embryo, Arteriovenous fistula, IDE, AVF, Medical imaging

Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.

Key Points: 
  • Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.
  • AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling.
  • The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow.
  • “IDE approval by the FDA’s Division of Coronary and Peripheral Interventional Devices is another validation of our novel approach to treating vascular disease,” said Dr. Myles Greenberg, CEO of Alucent Biomedical.

The Inner Circle Acknowledges, Patrick Tamim as a Top Pinnacle Professional for his contributions to the Vascular Surgery Field

Retrieved on: 
Friday, July 28, 2023
Emerald, Moyamoya disease, Surgeon, Society, University, Vein, Education, National Council on Aging, Stroke, Varicose veins, Southern Methodist University, Multimedia, Artery, Mentorship, Inner circle, Dialysis, Blood, Ageing, ABS, American Board of Commissioners for Foreign Missions, Patient, Council, Peripheral artery disease, Methodist University, Knowledge, American Board of Surgery, Hartford Hospital, Medical degree, Henry Ford Hospital, Aortic aneurysm, PANAMA, Dentistry, Nursing, Science, MD, Chemistry, Biology

PANAMA CITY, Fla., July 28, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Patrick Tamim is acknowledged as a Top Pinnacle Professional for his contributions to the Vascular Surgery Field.

Key Points: 
  • PANAMA CITY, Fla., July 28, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Patrick Tamim is acknowledged as a Top Pinnacle Professional for his contributions to the Vascular Surgery Field.
  • Dr. Tamim pursued higher education at Southern Methodist University where he earned a Bachelor of Science in Biology and Chemistry.
  • He capped his scholarship with a fellowship in vascular surgery at Hartford Hospital in Connecticut to complete his higher education.
  • In the field since 2010, the doctor provides treatment for carotid disease; aortic aneurysm; and peripheral artery disease surgery.

Humacyte Completes Enrollment in Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) for Vascular Trauma Repair

Retrieved on: 
Wednesday, July 26, 2023
Infection, Tissue, Amputation, Surgeon, Vein, Life, Trauma, Leg, Artery, Cell, Trauma center, Sale, Regenerative medicine, Pain, Ischemia, Literature, Food and Drug Administration Amendments Act of 2007, Injury, Patient, Risk, HUMA, Level, Peripheral artery disease, FDA, HAV, BLA, Food, Caregiver, Pharmaceutical industry

DURHAM, N.C., July 26, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced completion of enrollment of its Phase 2/3 vascular trauma trial (V005) that is expected to support a BLA filing for Humacyte’s HAV in vascular trauma repair. The HAV, an innovative regenerative medicine product candidate, is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries. The HAV has the potential to assist healthcare professionals in saving life and limb in some of the most difficult circumstances. The results from the Phase 2/3 vascular trauma trial are intended to support a BLA filing with the Food and Drug Administration (FDA), planned for the fourth quarter 2023.

Key Points: 
  • The results from the Phase 2/3 vascular trauma trial are intended to support a BLA filing with the Food and Drug Administration (FDA), planned for the fourth quarter 2023.
  • The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level 1 Trauma Centers in the U.S. and Israel.
  • Humacyte, the clinical trial sites, and contracted service providers are preparing for locking of the trial database in order to report the V005 results.
  • “The completion of the target enrollment in Humacyte’s Phase 2/3 vascular trauma trial is expected to enable BLA submission, and is another important landmark moment for our groundbreaking science.

Cagent Vascular announces initial RECOIL Study results: Serranator demonstrates 49% less recoil than POBA in BTK arteries

Retrieved on: 
Tuesday, July 11, 2023
Health, FDA, Surgery, Health Technology, General Health, Clinical Trials, Biotechnology, CE, Clear, Amputation, Stanford University, PAD, Fernand Serrane, Elective surgery, BTK, Sale, Peripheral artery disease, Wound healing, Patient, Risk, Mortality, CLTI, Dilation, Dissection, Telescopic sight, Medical imaging, POBA, MD

Cagent Vascular, the exclusive developer of serration technology for vessel dilatation in endovascular interventions, announced the results of its Below-the-Knee (BTK) RECOIL study.

Key Points: 
  • Cagent Vascular, the exclusive developer of serration technology for vessel dilatation in endovascular interventions, announced the results of its Below-the-Knee (BTK) RECOIL study.
  • This Core Lab-Adjudicated Recoil analysis, the first of its kind, evaluated vessel recoil in lesions treated with Serranator® verses Plain Old Balloon Angioplasty (POBA).
  • The study results demonstrated that lesions treated using Serration Angioplasty exhibited 49% less average recoil than POBA.
  • “The 49% difference demonstrated in the RECOIL study between Serranator® and POBA is statistically significant and in my view also clinically relevant.

JanOne files international patent application for methods of using low dose naltrexone to treat chronic pain

Retrieved on: 
Wednesday, June 28, 2023
Risk, Clinical trial, PAD, Hope, CRPS, Patent, Patient, Security (finance), FDA, Chronic pain, Netflix, Complex regional pain syndrome, Pharmaceutical industry, Peripheral artery disease, Janon

LAS VEGAS, June 28, 2023 /PRNewswire/ -- JanOne Inc. (Nasdaq: JAN), a biopharmaceutical company that is developing multiple drugs to treat chronic diseases like Peripheral Artery Disease (PAD) and Complex Regional Pain Syndrome (CRPS), has just filed an international patent application for methods of using low dose naltrexone to treat chronic pain.

Key Points: 
  • LAS VEGAS, June 28, 2023 /PRNewswire/ -- JanOne Inc. (Nasdaq: JAN), a biopharmaceutical company that is developing multiple drugs to treat chronic diseases like Peripheral Artery Disease (PAD) and Complex Regional Pain Syndrome (CRPS), has just filed an international patent application for methods of using low dose naltrexone to treat chronic pain.
  • JanOne is developing Jan123 (a novel formulation of low dose naltrexone) to treat CRPS, an orphan disease with no current FDA-approved treatments.
  • CRPS leaves patients in debilitating pain and suffering and, as a result, oftentimes patients resort to opioid pain medications.
  • "This international patent application is part of our strategy to help patients around the world who are suffering from this debilitating disease.

Surmodics Receives FDA Approval for the SurVeil™ Drug-Coated Balloon

Retrieved on: 
Tuesday, June 20, 2023
Medical Supplies, Health, FDA, Medical Devices, Clinical Trials, Pharmaceutical, Cardiology, Ankle, Freedom, Amputation, Food and Drug Administration, Clinical trial, Paclitaxel, Postmarketing surveillance, Leg, History, De novo, DCB, Patient, Physician, European, Peripheral artery disease, Certification, Food, Safety, Pharmaceutical industry

Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the receipt of U.S. Food and Drug Administration (FDA) approval for the SurVeil™ drug-coated balloon (DCB).

Key Points: 
  • Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the receipt of U.S. Food and Drug Administration (FDA) approval for the SurVeil™ drug-coated balloon (DCB).
  • “Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, President and CEO of Surmodics.
  • Surmodics will manufacture and supply the product and realize revenue from product sales to Abbott and a share of profits from Abbott’s third-party sales.
  • Mr. Maharaj continued, “Building on our recent progress, Surmodics remains focused on supporting Abbott and its exclusive worldwide commercialization rights for the SurVeil DCB.

NIH Approves Second Phase of Funding to Support IND-enabling Work for Ambulero Gene Therapy to Treat Vascular Disease

Retrieved on: 
Monday, June 12, 2023
Health, Genetics, Clinical Trials, Research, Science, Cardiology, Biotechnology, University, NIH, Amputation, Catalysis, University of Florida, National Heart, Lung, and Blood Institute, Vasculitis, IP, Lung, AAV, Doctor of Philosophy, Bangladesh Technical Education Board, Peripheral artery disease, NHLBI, US, Partner, MD, FACS, IND, Pharmaceutical industry

Ambulero, Inc. is developing a first-in-class gene and cell therapy platform for treating serious vascular diseases and non-healing wounds where amputation is a care option.

Key Points: 
  • Ambulero, Inc. is developing a first-in-class gene and cell therapy platform for treating serious vascular diseases and non-healing wounds where amputation is a care option.
  • Drs.
  • Velazquez and Liu are focused on advancing E-selectin/AAV gene therapies for the treatment of arterial occlusive diseases such as Peripheral Artery Disease with Chronic Limb Threatening Ischemia.
  • For more information about Ambulero, please see www.ambulero.com
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