Cardiopulmonary bypass

Haemonetics Receives FDA Clearance for New TEG® 6s Global Hemostasis - HN Cartridge

Retrieved on: 
Thursday, April 4, 2024
6S, Heparinoid, Patient, HAE, Liver transplantation, MD, Senior, Hemostasis, Heparin, Cardiopulmonary bypass, Safety, FDA, TEG, Physician, Food, Medical device

This new cartridge extends Haemonetics' TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.

Key Points: 
  • This new cartridge extends Haemonetics' TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.
  • Haemonetics is planning to release the new Global Hemostasis-HN cartridge for TEG 6s system in the coming months.
  • Overall, over 5,500 clinical data points were used to demonstrate safety and effectiveness of the Global Hemostasis – HN assays.
  • "Our market-leading TEG 6s platform has helped Haemonetics make effective and efficient viscoelastic testing more accessible throughout the world," said Stewart Strong, President, Global Hospital at Haemonetics.

CytoSorbents Provides Update on the STAR-T Trial and Reports Final Independent Data and Safety Monitoring Board Recommendation

Retrieved on: 
Thursday, December 28, 2023
Patient, Safe, DSMB, Cardiology, Cardiopulmonary bypass, Acute coronary syndrome, Risk, AstraZeneca, Cytosorbents Corporation, FDA, Bleeding, International, Data analysis, Disease, Mortality, De novo, Professional corporation, Randomized controlled trial, CABG, Public, Health Canada, American College, International Star Registry, Safety, Data monitoring committee, PMA, Senior, Pharmaceutical industry

The independent DSMB met recently to perform the final review of the full unblinded data on all 140 patients in the STAR-T trial and concluded there were no issues with device safety, meeting the primary safety endpoint of the study.

Key Points: 
  • The independent DSMB met recently to perform the final review of the full unblinded data on all 140 patients in the STAR-T trial and concluded there were no issues with device safety, meeting the primary safety endpoint of the study.
  • The Company expects to complete the analysis of the full trial results in the next several weeks.
  • Pending this final analysis, the Company believes the safety and effectiveness data from STAR-T may support the regulatory submission of DrugSorb-ATR to the U.S. FDA and Health Canada.
  • If accepted, the full results of the STAR-T trial are expected to be presented next April 2024 in Atlanta.

Arch Biopartners Receives Approval from Ethics Committee in Turkey to Proceed with Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Retrieved on: 
Thursday, December 21, 2023
Clinical trial, Liver, Arch, AKI, Conlon, Reperfusion, Risk, IRI, Prevalence, Ethics, Disease, Mortality, TMX Group, Science Advances, Cardiopulmonary bypass, Inflammation, CPB, Renal replacement therapy, National Research Council, Oxygen, Acute kidney injury, OTCQB, CABG, MOH, Health Canada, Kidney, Injury, Patient, Ischemia, Dialysis, Pharmaceutical industry

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The ethics committee approval of the trial will be followed by a final regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-January.
  • Once the trial is approved by the MoH, activation of clinical sites in Turkey will take place and patient enrollment can begin in February.
  • Quote from Richard Muruve, CEO of Arch Biopartners Inc:
    “We look forward to a positive decision from the MoH, which will permit enrollment of Turkish cardiac surgery patients into the trial.

Arch Biopartners Submits Application to Health Canada to Conduct the Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Retrieved on: 
Wednesday, December 13, 2023
Clinical trial, Phase, Liver, Arch, Food, AKI, Conlon, Reperfusion, Risk, IRI, FDA, Prevalence, Disease, Mortality, TMX Group, Science Advances, Cardiopulmonary bypass, Inflammation, Investigational New Drug, CPB, Renal replacement therapy, National Research Council, Oxygen, Acute kidney injury, OTCQB, CABG, Health Canada, Kidney, Patient, Safety, Ischemia, Dialysis, Pharmaceutical industry

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The FDA granted the Company permission to proceed with a Phase II trial in late June .
  • Quote from Richard Muruve, CEO of Arch Biopartners Inc:
    “The clinical trial application submitted to Health Canada is the result of clinical interest in Canada to support our Phase II trial targeting CS-AKI.
  • LSALT peptide has been shown to prevent ischemia reperfusion injury (IRI) to the kidneys in pre-clinical models , providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

United States DSUVIA (sufentanil) Drug Insight and Market Forecasts, 2019-2022 and 2023-2032 - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023
Health, Pharmaceutical, CNS, Pain, Research, Tablet, Sufentanil, Clinical trial, Cleveland Clinic, Patient, SWOT, Hospital, Cardiopulmonary bypass, Poultry farming, Dietary supplement, Pharmaceutical industry

The "United States DSUVIA Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "United States DSUVIA Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about DSUVIA for acute pain in the United States.
  • A detailed picture of the DSUVIA for acute pain in the United States for the study period 2019 -2032 is provided in this report along with a detailed description of the DSUVIA for acute pain.
  • This report provides a detailed market assessment of DSUVIA for acute pain in the United States.

Arch Biopartners Submits Application to the Turkish Ministry of Health to Conduct a Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Retrieved on: 
Friday, September 22, 2023
Conlon, CABG, Prevalence, Science Advances, Acute kidney injury, Oxygen, MOH, OTCQB, CPB, Arch, IRI, Inflammation, Ethics committee, AKI, Dialysis, Data monitoring committee, Cardiopulmonary bypass, Ministry, Ischemia, Investigational New Drug, Patient, TMX Group, Risk, Renal replacement therapy, Disease, Kidney, Ministry of Health (Kuwait), Reperfusion, Liver, Mortality, FDA, Food, Safety, National Research Council, Pharmaceutical industry, Hospital

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • This application in Turkey follows the Company’s submission of an Investigational New Drug Application to the U.S. Food and Drug Administration’s (FDA).
  • The FDA subsequently granted the Company permission to proceed with this Phase II trial in late June .
  • Of this total, the application to the MoH requests permission to recruit up to 150 patients in Turkey.

LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark

Retrieved on: 
Wednesday, August 30, 2023
Cardiology, Software, Health, FDA, Medical Devices, Health Technology, Technology, Other Health, Partnership, PLC, ILBM, LIVN, Perfusion, Hematocrit, Oxygen, CE marking, Food and Drug Administration, LivaNova, CPB, Multimedia, Temperature, Cardiopulmonary bypass, Sale, United Arab Emirates, CLIA, Journal, Acute kidney injury, GDP, Patient, Risk, Stazione Sperimentale per le Industrie delle Essenze e dei Derivati dagli Agrumi, Clinical Laboratory Improvement Amendments, Perfusionist, HLM, Partial pressure, Food, Monitoring (medicine), Medical device, Medical imaging

LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark for its Essenz™ In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures.

Key Points: 
  • LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark for its Essenz™ In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures.
  • “Dynamic conditions can rapidly change a patient’s blood parameters during a cardiopulmonary bypass procedure,” said Marco Dolci, LivaNova President, Cardiopulmonary.
  • “The Essenz In-Line Blood Monitor provides continuous monitoring throughout a patient’s procedure.
  • It consists of a next-generation heart-lung machine (HLM), a patient monitor and accurate sensing technology that now includes the ILBM.

Trisol announces successful implants of its Transcatheter Tricuspid Valve in the US

Retrieved on: 
Wednesday, August 23, 2023
University of Virginia Health System, University, TR, Food and Drug Administration, Cardiopulmonary bypass, Risk, Valvular heart disease, EFS, Principal, Food, Medical device, Trisol, MD

YOKNEAM, Israel, Aug. 23, 2023 /PRNewswire/ -- The heart teams at the Piedmont Heart Institute in Atlanta, Georgia, USA and the University of Virginia Health System in Charlottesville, VA, USA, successfully performed the first two implantations in the US of the Trisol Transcatheter Tricuspid Valve Replacement as part of a U.S. Food and Drug Administration approved Early Feasibility Study (EFS), led by Principal Investigator Isaac George, MD.

Key Points: 
  • We were able to abolish the patient's valvular heart disease via a minimally invasive procedure without the need for cardiopulmonary bypass.
  • Trisol patented valve features a distinctive design, that sets it apart from other tricuspid valves technologies.
  • Trisol valve is comprised of a single leaflet, the leaflet is affixed by 2 commissures enabling it to function as a bi-leaflet valve.
  • Five of these implants were performed as part of the Israeli Pilot Study, led by Principal Investigator Ran Kornowski, MD.

Aquedeon Medical, Inc. Receives FDA IDE Approval for the Duett Vascular Graft System

Retrieved on: 
Wednesday, August 23, 2023
Surgeon, University, Clinical trial, Federal, Thoracic aortic aneurysm, Social Democratic Federation (United States), Penn Presbyterian Medical Center, Cardiopulmonary bypass, Silicon, Patient, Cardiac surgery, Risk, Principal, IDE, FDA, Dentistry

The procedure often requires 30-45 minutes of surgical time to complete anastomoses where the cardiothoracic surgeon sutures each individual native branch vessel to the surgical graft.

Key Points: 
  • The procedure often requires 30-45 minutes of surgical time to complete anastomoses where the cardiothoracic surgeon sutures each individual native branch vessel to the surgical graft.
  • The Duett Vascular Graft System was uniquely designed to standardize and simplify open surgical thoracic aortic procedures with the goal of providing cardiothoracic surgeons a means to treat the target vessels effectively and efficiently.
  • Dr. Szeto also highlighted his longstanding involvement with the Duett Vascular Graft System's evolution, since the company's inception, and expressed enthusiasm about participating in the imminent clinical trial.
  • "The Duett Vascular Graft System has been developed in collaboration with leading cardiothoracic surgeon and the device is aimed at helping to address the complexities and intricacies of thoracic aortic surgeries.

Trisol announces successful implants of its Transcatheter Tricuspid Valve in the US

Retrieved on: 
Wednesday, August 23, 2023
University of Virginia Health System, University, TR, Food and Drug Administration, Cardiopulmonary bypass, Risk, Valvular heart disease, EFS, Principal, Food, Medical device, Trisol, MD

YOKNEAM, Israel, Aug. 23, 2023 /PRNewswire/ -- The heart teams at the Piedmont Heart Institute in Atlanta, Georgia, USA and the University of Virginia Health System in Charlottesville, VA, USA, successfully performed the first two implantations in the US of the Trisol Transcatheter Tricuspid Valve Replacement as part of a U.S. Food and Drug Administration approved Early Feasibility Study (EFS), led by Principal Investigator Isaac George, MD.

Key Points: 
  • We were able to abolish the patient's valvular heart disease via a minimally invasive procedure without the need for cardiopulmonary bypass.
  • Trisol patented valve features a distinctive design, that sets it apart from other tricuspid valves technologies.
  • Trisol valve is comprised of a single leaflet, the leaflet is affixed by 2 commissures enabling it to function as a bi-leaflet valve.
  • Five of these implants were performed as part of the Israeli Pilot Study, led by Principal Investigator Ran Kornowski, MD.