Aorta

JenaValve’s Trilogy THV System Highlighted at CRT 2024

Retrieved on: 
Tuesday, March 19, 2024
Observational study, CRT, Conference, Herpetology, Disease, Aortic regurgitation, Patient, Aortic stenosis, Treatment, TAVR, Trilogy, THV, Aorta

IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the Cardiovascular Research Technologies (CRT) Conference 2024.

Key Points: 
  • IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the Cardiovascular Research Technologies (CRT) Conference 2024.
  • JenaValve’s Trilogy THV system, a TAVR system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR), and symptomatic, severe aortic stenosis (ssAS), was featured in multiple scientific sessions highlighting the significant unmet need for devices to treat ssAR.
  • This session reviewed an observational study examining outcomes of patients with ssAR treated with off-label THV’s versus a device designed to treat ssAR.
  • Results showed significantly better technical and device success in the Trilogy arm, with significantly less valve embolization, need for a second valve, and post-procedural aortic regurgitation.

PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions

Retrieved on: 
Monday, March 11, 2024
Certification, Aorta, MDD, Risk, Patient, Femoral artery, Medical device, Diastole, MCS, Interventional cardiology, MDR, Pump, PCI, Safety, Blood, Medical device regulation

The MDR CE certification signifies PulseCath's commitment to the highest standards of quality and safety in medical devices.

Key Points: 
  • The MDR CE certification signifies PulseCath's commitment to the highest standards of quality and safety in medical devices.
  • The iVAC 2L System is a percutaneous Mechanical Circulatory Support (MCS) device.
  • It can be used to facilitate high-risk Percutaneous Coronary Interventions (PCIs).
  • iVAC 2L represents a leap forward in complex High-Risk PCI's, and we are eager to make this transformative device available to healthcare providers and patients worldwide."

PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions

Retrieved on: 
Monday, March 11, 2024
Certification, Aorta, MDD, Risk, Patient, Femoral artery, Medical device, Diastole, MCS, Interventional cardiology, MDR, Pump, PCI, Safety, Blood, Medical device regulation

The MDR CE certification signifies PulseCath's commitment to the highest standards of quality and safety in medical devices.

Key Points: 
  • The MDR CE certification signifies PulseCath's commitment to the highest standards of quality and safety in medical devices.
  • The iVAC 2L System is a percutaneous Mechanical Circulatory Support (MCS) device.
  • It can be used to facilitate high-risk Percutaneous Coronary Interventions (PCIs).
  • iVAC 2L represents a leap forward in complex High-Risk PCI's, and we are eager to make this transformative device available to healthcare providers and patients worldwide."

Orchestra BioMed Announces Presentation of Results from Clinical Study Demonstrating Favorable Hemodynamic Effects of AVIM Therapy In Hypertensive Pacemaker Patients

Retrieved on: 
Wednesday, March 6, 2024
Blood pressure, PV, HOPE, Beat (music), Overalls, Cardiac output, Stroke, Safety, Hypertension, Aorta, Patient, Hemodynamics, RV, DDD, Heart failure, Medical device

These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.

Key Points: 
  • These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.
  • The PV loop study was conducted at Na Homolce Hospital in Prague by Prof. Petr Neužil, M.D.
  • AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure.
  • “Well-conducted invasive PV loop studies are a robust way to evaluate the impact of a novel therapy like AVIM on hemodymanics and overall cardiac function.

CardioSignal Raises $10 Million in Series A as the First Technology to Detect Major Heart Diseases without Specialized Medical Hardware

Retrieved on: 
Tuesday, January 23, 2024
Research, Telemedicine, Virtual Medicine, Insurance, Software, Medical Devices, Internet, Hardware, Professional Services, Consumer Electronics, Science, Technology, Mobile, Wireless, Clinical Trials, Cardiology, Health, Apps, Applications, Health Technology, Health Insurance, Atrial fibrillation, Death, Coronary artery disease, Patient, Heart, Aortic stenosis, Aorta, Heart failure, Mayo Clinic, Risk, Xerox, Biomarker, Sandwater, Pulmonary hypertension, Motion, Smartphone, Pharmaceutical industry

The Series A investment will fund additional clinical validation of CardioSignal’s breakthrough technology and the expansion of its commercial efforts.

Key Points: 
  • The Series A investment will fund additional clinical validation of CardioSignal’s breakthrough technology and the expansion of its commercial efforts.
  • CardioSignal develops digital technologies and software-as-medical-devices to provide early detection of heart diseases, and provides the first and only technology to detect several major heart diseases with high accuracy using just one clinical modality without any specialized medical equipment.
  • CardioSignal’s technology harnesses gyroscope and accelerometer motion data from smartphones to measure specific rotational movements of the heart that can be used to accurately detect abnormal heart function.
  • Currently, primary care has very limited tools to detect heart diseases, like heart failure patients who are often already experiencing symptoms.

Prytime Medical Announces 500th Patient Case Using pREBOA-PRO™ Catheter Designed for True Partial REBOA

Retrieved on: 
Tuesday, December 5, 2023
Organ, Research, SAN, Center of excellence, AKI, Partial, Surgeon, Patient, Science, REBOA, MD, Trauma, Acute kidney injury, Bleeding, Hospital, Physician, PROMPT, Aorta, Blood pressure, Medical device, Medical imaging, Dentistry, Pharmaceutical industry

SAN ANTONIO, Dec. 5, 2023 /PRNewswire-PRWeb/ -- Prytime Medical Devices Inc, The REBOA Company™, the leading innovator and global provider of lifesaving REBOA products for minimally invasive, endovascular hemorrhage control, announced reaching the milestone of 500 patient uses with its lifesaving pREBOA-PRO™ catheter.

Key Points: 
  • Partial REBOA, or partial occlusion of the aorta, allows the viscera to be sufficiently perfused during the REBOA procedure.
  • "When we launched pREBOA-PRO™ in 2021, we assumed that partial REBOA using pREBOA-PRO™ would have an enhanced value proposition from complete REBOA.
  • "The physicians at the Centers of Excellence continue to invest in additional research to broaden our understanding of partial REBOA using the pREBOA-PRO™ catheter."
  • In March 2023, Prytime Medical announced the launch of the Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) Study, the first large-scale multicenter prospective study for Partial REBOA.

New Published Study Demonstrates Safety and Feasibility of Filterlex Medical's CAPTIS® Device in Providing Embolic Protection During TAVR

Retrieved on: 
Wednesday, November 15, 2023
TAVR, Brain, Safety, Risk, Patient, FIH, Stroke, MD, Aortic stenosis, CMO, EuroIntervention, Aorta, Travel, Medical device, Medical imaging

CAESAREA, Israel, Nov. 15, 2023 /PRNewswire/ -- Filterlex Medical Ltd., a cardiovascular medical device startup, announced today the publication of a first-in-human (FIH) study in the peer-reviewed cardiovascular journal, EuroIntervention. The study validates the safety and feasibility of the next generation CAPTIS® full-body embolic protection device during TAVR procedures.

Key Points: 
  • The study validates the safety and feasibility of the next generation CAPTIS® full-body embolic protection device during TAVR procedures.
  • In the published study, the CAPTIS® system captured a high number of embolic debris particles, providing embolic protection and enhancing safety during TAVR procedures.
  • The study, which included 20 patients undergoing TAVR procedures with the CAPTIS® device, demonstrated a 100% success rate in the use of the device.
  • This study sheds light on the capability of the CAPTIS® device to deliver neurovascular and systemic embolic protection, crucial for lowering the risk of stroke and other embolic events during TAVR procedures.

New Published Study Demonstrates Safety and Feasibility of Filterlex Medical's CAPTIS® Device in Providing Embolic Protection During TAVR

Retrieved on: 
Wednesday, November 15, 2023
TAVR, Brain, Safety, Risk, Patient, FIH, Stroke, MD, Aortic stenosis, CMO, EuroIntervention, Aorta, Travel, Medical device, Medical imaging

CAESAREA, Israel, Nov. 15, 2023 /PRNewswire/ -- Filterlex Medical Ltd., a cardiovascular medical device startup, announced today the publication of a first-in-human (FIH) study in the peer-reviewed cardiovascular journal, EuroIntervention. The study validates the safety and feasibility of the next generation CAPTIS® full-body embolic protection device during TAVR procedures.

Key Points: 
  • The study validates the safety and feasibility of the next generation CAPTIS® full-body embolic protection device during TAVR procedures.
  • In the published study, the CAPTIS® system captured a high number of embolic debris particles, providing embolic protection and enhancing safety during TAVR procedures.
  • The study, which included 20 patients undergoing TAVR procedures with the CAPTIS® device, demonstrated a 100% success rate in the use of the device.
  • This study sheds light on the capability of the CAPTIS® device to deliver neurovascular and systemic embolic protection, crucial for lowering the risk of stroke and other embolic events during TAVR procedures.

CytoSorbents Highlights Upcoming Presentations at EACTS 2023: Focus on Antithrombotic Removal including the 2nd Analysis of the International STAR Registry

Retrieved on: 
Wednesday, September 27, 2023
CABG, Percutaneous coronary intervention, Anticoagulant, International, Bleeding, Intraparenchymal hemorrhage, CET, Boehringer, Dabigatran, STAR, EACTS, Edoxaban, Acute coronary syndrome, International Star Registry, Cytokine adsorbing column, CTD, Research, AstraZeneca, Professional corporation, Eli Lilly, Clopidogrel, DOAC, Boehringer Ingelheim, Incidence, Bayer, Neurosurgery, International Safe Harbor Privacy Principles, Patient, Risk, European Heart Journal, Daiichi Sankyo, Blood, Rivaroxaban, Annual general meeting, Cytosorbents Corporation, United Kingdom, BMS, Cardiology, European Association for Cardio-Thoracic Surgery, Starship Enterprise, Trauma, Ticagrelor, ATR, Pfizer, Birth control, Pharmaceutical industry, Dentistry, Janssen, Aorta, Sanofi

The International STAR Registry captures high fidelity data on real-world clinical use and associated clinical outcomes using CytoSorb® for antithrombotic drug removal (ATR) in the acute hospital setting.

Key Points: 
  • The International STAR Registry captures high fidelity data on real-world clinical use and associated clinical outcomes using CytoSorb® for antithrombotic drug removal (ATR) in the acute hospital setting.
  • The STAR Registry, not to be confused with the completed U.S. and Canada STAR-T pivotal trial, is enrolling ahead of internal projections with plans for ongoing presentations at large, international conferences.
  • The first registry analysis entitled, “ Insights from the International Safe and Timely Antithrombotic Removal (STAR) Registry ” was presented at the EuroPCR conference in May 2023, the largest interventional cardiology conference in the E.U., attracting 11,500+ participants this year.
  • It also includes, for the first time, data on patients being treated with CytoSorb to reduce seven different antithrombotic medications.

Desktop Health™ Introduces the PrintRoll™ Rotating Build Platform for the 3D-Bioplotter® — a First-of-its-kind Bioprinting Tool to Develop Tubular Solutions for Vascular, Digestive, Respiratory, and Other Channels

Retrieved on: 
Monday, July 24, 2023
Surgery, Medical Devices, Hospitals, Clinical Trials, Stem Cells, Cardiology, Biotechnology, Health, Pharmaceutical, Desktop Metal, DM, Honeycomb, Gel, Aorta, Sterility, Printing, 3D, 3D bioprinting, University of Mainz, Innovation, Temperature, Cell, 30 mm caliber, Trachea, Regenerative medicine, PCL, Femoral artery, Human body, FDA, NYSE, 3D printing, Publishing

View the full release here: https://www.businesswire.com/news/home/20230724680554/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230724680554/en/
    Nicole Black, Ph.D., VP of Biomaterials and Innovation at Desktop Health, examines two tubular medical devices printed on the new 3D-Bioplotter® PrintRoll™ rotating build platform in medical-grade materials.
  • PrintRoll is designed to enable new medical solutions for the body’s thousands of miles of internal channels, such as vascular, digestive, and other systems.
  • 3D-Bioplotter offers eight printheads with the widest range of temperatures in bioprinting — from 2°C to 500°C (35.6°F to 932°F) — enabling complex, multi-material medical parts.
  • As the PrintRoll tool rotates, the printhead moves back and forth depositing material on the surface in the desired design.