Cardiovascular system

MyoStrain® Provides Comprehensive Assessment of Myocardial Deformation to Help Physicians Risk-Stratify Heart Failure Patients for Individualized Cardiac Treatment

Retrieved on: 
Monday, April 19, 2021

[ 1 ]\nSebastian Kelle, MD, PhD, FSCMR, Head of Cardiac Imaging at the Berlin Center and the study\'s primary investigator, commented: "The study highlights the importance of using both longitudinal and circumferential strain to assess myocardial deformation in cardiac patients.

Key Points: 
  • [ 1 ]\nSebastian Kelle, MD, PhD, FSCMR, Head of Cardiac Imaging at the Berlin Center and the study\'s primary investigator, commented: "The study highlights the importance of using both longitudinal and circumferential strain to assess myocardial deformation in cardiac patients.
  • This makes MyoStrain a critical tool for physicians to evaluate cardiac patients, as it uses both of these metrics in a single MyoHealth risk score.
  • This information may help to guide individualized treatment decisions and potentially mitigate future dysfunction progression by monitoring the functional effects of treatment on the heart over time.
  • (2021)Myocardial deformation assessed among heart failure entities by cardiovascular magnetic resonance imaging.ESC Heart Failure, https://doi.org/10.1002/ehf2.13193\n'

Harmony Biosciences To Present WAKIX® (Pitolisant) Data At The 2021 AAN Annual Meeting

Retrieved on: 
Monday, April 12, 2021

"We look forward to sharing these data and the results of these analyses with both the neurology and narcolepsy communities.

Key Points: 
  • "We look forward to sharing these data and the results of these analyses with both the neurology and narcolepsy communities.
  • "\nThe data that will be presented by Harmony will be available from 7 a.m.-5 p.m. EDT on April 17-22, and include:\nTime to Onset of Clinical Response During Treatment with Pitolisant (P26.015).
  • WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate impairment.\nWAKIX prolongs the QT interval.
  • Avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval.

BioSig lands Commercial Sales to Leading Hospital System

Retrieved on: 
Tuesday, April 6, 2021

We are pleased to expand our commercial installations across this most important healthcare system in multiple states.

Key Points: 
  • We are pleased to expand our commercial installations across this most important healthcare system in multiple states.
  • commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc. We expect to see further commercial sales in coming weeks and months
    More than 680 patient cases have been conducted with the PURE EP System to date across eight clinical sites.
  • The PURE EP System is being used in all types of arrhythmia cases, including atrial fibrillation, ventricular tachycardia, and atrial flutter.
  • We are excited to see leading electrophysiologists and institutions commercially adopt the PURE EP system which we believe demonstrates acceptance of the unique benefits of our system platform, software, and data, added Londoner.

S4 Medical Closes Series A Financing

Retrieved on: 
Friday, April 2, 2021

CLEVELAND, April 2, 2021 /PRNewswire/ -- S4 Medical moves a step closer in developing the most comprehensive solution to protect the esophagus from thermal injury during catheter ablation procedures for atrial fibrillation (AF) with the closing of their Series A financing.

Key Points: 
  • CLEVELAND, April 2, 2021 /PRNewswire/ -- S4 Medical moves a step closer in developing the most comprehensive solution to protect the esophagus from thermal injury during catheter ablation procedures for atrial fibrillation (AF) with the closing of their Series A financing.
  • S4 Medical was cofounded by Dr. Emile Daoud of The Ohio State University, and William Fuller.
  • Jumpstart, which focuses on early stage investing and has been involved with S4 from the start, also reinvested in the Series A round.
  • S4 Medical Corp. is a medical device company focused on innovative solutions for cardiac procedures.

Lawrence Berkeley National Laboratory Introduces New Method to Monitor Endothelial Function, Aiding Prevention, Treatment of Heart Disease

Retrieved on: 
Wednesday, March 31, 2021

Lawrence Berkeley National Laboratory (Berkeley Lab) has announced a new non-invasive method employing cuff-based measurement of flow-mediated dilation to detect preclinical cardiovascular disease.

Key Points: 
  • Lawrence Berkeley National Laboratory (Berkeley Lab) has announced a new non-invasive method employing cuff-based measurement of flow-mediated dilation to detect preclinical cardiovascular disease.
  • The new method will enable the accurate, inexpensive, and routine detection and monitoring of preclinical cardiovascular disease via both endothelial function and endothelium-independent vasodilation.
  • The novel method is the only noninvasive vasorelaxation assessment technique to achieve the previously unprecedented accuracy of invasive methods such as ultrasonic imaging.
  • Berkeley Lab is a multiprogram national laboratory, managed by the University of California for the U.S. Department of Energys Office of Science.

Shockwave Provides Update on U.S. Launch of Coronary IVL System

Retrieved on: 
Tuesday, March 30, 2021

The entire Shockwave Medical organization remains focused on our mission to deliver life changing products to patients suffering from calcified arterial disease.

Key Points: 
  • The entire Shockwave Medical organization remains focused on our mission to deliver life changing products to patients suffering from calcified arterial disease.
  • The C2 System was approved by the U.S. Food and Drug Administration on February 12, 2021 for use in calcified de-novo coronary arteries prior to implanting a stent.
  • Over 120 U.S. customers have purchased the C2 Launch Kit, with initial launch orders averaging approximately six C2 units.
  • Nearly 50% of U.S. accounts that have initiated launch have completed the launch activities and are able to use IVL independently.

Physicians In The U.S. Begin Commercial Use Of The GORE® EXCLUDER® Conformable AAA Endoprosthesis With ACTIVE CONTROL System

Retrieved on: 
Tuesday, March 30, 2021

FLAGSTAFF,Ariz., March 30, 2021 /PRNewswire/ --Today, W.L.Gore& Associates, Inc. (Gore) announces the first use of the FDA approved GORE EXCLUDERConformable AAA Endoprothesis with ACTIVE CONTROL System in cases outside of clinical trials.

Key Points: 
  • FLAGSTAFF,Ariz., March 30, 2021 /PRNewswire/ --Today, W.L.Gore& Associates, Inc. (Gore) announces the first use of the FDA approved GORE EXCLUDERConformable AAA Endoprothesis with ACTIVE CONTROL System in cases outside of clinical trials.
  • "Gore has combined a novel stent design, device conformability and an enhanced delivery system to give physicians even more control when we need it most."
  • For more information on the GORE EXCLUDER Conformable AAA Endoprosthesis and the GORE EXCLUDER Device family, visit goremedical.com .
  • Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms.

FDA Grants Breakthrough Device Designation to Tempus’ Atrial Fibrillation ECG Analysis Platform, Developed in Collaboration With Geisinger

Retrieved on: 
Wednesday, March 24, 2021

Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its ECG Analysis Platform.

Key Points: 
  • Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its ECG Analysis Platform.
  • The platform, developed in collaboration with Geisinger, aids clinicians in identifying patients at increased risk of developing atrial fibrillation (AFib) or atrial flutter.
  • The device analyzes the results of a 12-lead ECG administered as part of routine care to provide clinicians with insight into a patient's risk of future atrial fibrillation and/or atrial flutter events.
  • The Tempus ECG Analysis Platform is tackling that challenge by analyzing results of a widely-used clinical test, the 12-lead ECG, with software that identifies patients at increased risk of developing AFib or atrial flutter within the next 12 months.

Study Published in JAMA Cardiology Finds Zio by iRhythm Proactively Identifies Atrial Fibrillation, Increases Detection Tenfold

Retrieved on: 
Wednesday, February 24, 2021

The transatlantic clinical trial found that Zio by iRhythm , an ambulatory cardiac monitoring solution, led to a tenfold increase in the detection of atrial fibrillation (AF) versus patients receiving standard clinical care.

Key Points: 
  • The transatlantic clinical trial found that Zio by iRhythm , an ambulatory cardiac monitoring solution, led to a tenfold increase in the detection of atrial fibrillation (AF) versus patients receiving standard clinical care.
  • The study results lend support for Zio as a screening tool for early detection of AF.
  • iRhythm is a leading digital healthcare company redefining the way cardiac arrhythmias are clinically diagnosed.
  • The company believes improvements in arrhythmia detection and characterization have the potential to change the clinical management of patients.

Occlutech announces Completion of Patient Enrolment in Pilot Study of Atrial Flow Regulator (AFR) in Patients with Heart Failure

Retrieved on: 
Wednesday, February 24, 2021

Even with the best medical therapy, many patients experience persistent symptoms and low quality of life as a result of elevated left atrial pressure.

Key Points: 
  • Even with the best medical therapy, many patients experience persistent symptoms and low quality of life as a result of elevated left atrial pressure.
  • "The completion of the enrolment is another important milestone for Occlutech and we are excited to support this therapy option for heart failure patients with our clinical activities."
  • Occlutech has sales of congenital and structural heart products in over 80 countries and maintains manufacturing and R&D facilities in Jena,GermanyandIstanbul,Turkey.
  • The AFR is under clinical investigation for use in patients with pulmonary arterial hypertension and use in these patients is limited by applicable national laws.