Cardiovascular system

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.

InspireMD Engages Hart Clinical Consultants to Conduct Clinical Trial for CGuard Carotid Stent System in the United States

Retrieved on: 
Wednesday, February 24, 2021

TEL AVIV, Israel, Feb. 24, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today that it has engaged Hart Clinical Consultants (HCC), a leading Contract Research Organization (CRO) to conduct the clinical trial for its CGuard Carotid Stent System in the United States.

Key Points: 
  • TEL AVIV, Israel, Feb. 24, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today that it has engaged Hart Clinical Consultants (HCC), a leading Contract Research Organization (CRO) to conduct the clinical trial for its CGuard Carotid Stent System in the United States.
  • HCC is ideally suited to manage this trial having supported clinical trial operations for a variety of products and indications, including with multiple carotid intervention procedures, stated Marvin Slosman, InspireMDs CEO.
  • This will be the first U.S.-based study of CGuard and our opportunity to demonstrate its potential for the prevention of stroke caused by carotid artery disease in patients in the United States.
  • We look forward to working with InspireMD on this pivotal trial of the CGuard System to help establish a new standard of care for the management of carotid artery disease and stroke prevention.

Study Confirms Elucid’s AI Software Accurately Estimates Lesion-Specific Ischemia Compared to Standard of Care

Retrieved on: 
Thursday, February 18, 2021

The study, entitled Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve demonstrates that Fractional Flow Reserve (FFR) assessment derived from non-invasive plaque morphology using Elucids software is highly accurate as compared to invasive FFR.

Key Points: 
  • The study, entitled Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve demonstrates that Fractional Flow Reserve (FFR) assessment derived from non-invasive plaque morphology using Elucids software is highly accurate as compared to invasive FFR.
  • These measurements were fed into Elucids computational neural networks to accurately estimate ischemia.
  • The combination of Computed Tomography-based Fractional Flow Reserve (FFRct) and plaque morphology provides the clearest overview of myocardial ischemia in order to determine treatment options for a patient.
  • Leveraging Elucids software, the study demonstrated a strong level of sensitivity and specificity relative to invasive FFR.

Novartis Entresto® granted expanded indication in chronic heart failure by FDA

Retrieved on: 
Tuesday, February 16, 2021

For the first time, there is a treatment with benefit for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3.

Key Points: 
  • For the first time, there is a treatment with benefit for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3.
  • Approximately 6 million Americans are living with chronic heart failure (CHF)4.
  • In the United States, Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure1.
  • Accessed July 2019. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Info...
    Langenickel T, Dole W. Angiotensin receptor-neprilysin inhibition with LCZ696: a novel approach for the treatment of heart failure.

RSIP Vision Announces Sophisticated AI-Based Tool for Coronary Artery Analysis and Intervention Planning

Retrieved on: 
Tuesday, February 16, 2021

RSIP Vision , an experienced leader in driving innovation for medical imaging through advanced AI and computer vision solutions, today announces a new coronary artery segmentation tool.

Key Points: 
  • RSIP Vision , an experienced leader in driving innovation for medical imaging through advanced AI and computer vision solutions, today announces a new coronary artery segmentation tool.
  • This tool enhances image-based assessments of coronary artery function and diagnosis of conditions, such as narrowing (stenosis).
  • It also provides the needed understanding to physicians for advanced procedure planning, including navigation planning, stent selection, and stent positioning.
  • We are pleased to introduce our new module that will aid in the detection of coronary artery stenosis and be useful in percutaneous coronary intervention (PCI) planning.

Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease

Retrieved on: 
Tuesday, February 16, 2021

With this approval, IVL is now commercially available in the United States to treat problematic calcium in the coronary arteries, which can reduce blood flow in the heart.

Key Points: 
  • With this approval, IVL is now commercially available in the United States to treat problematic calcium in the coronary arteries, which can reduce blood flow in the heart.
  • As coronary artery disease progresses, plaque in the arterial wall often evolves into calcium deposits, which narrow the artery and restrict blood flow.
  • Intravascular Lithotripsy uses sonic pressure waves, also known as shockwaves, that pass through soft arterial tissue and preferentially disrupt calcified plaque by creating a series of micro-fractures.
  • Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated.

Global Atrial Fibrillation Pipeline Insight Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 16, 2021

The "Atrial Fibrillation - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Atrial Fibrillation - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "Atrial Fibrillation - Pipeline Insight, 2021," report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Atrial Fibrillation pipeline landscape.
  • This segment of the Atrial Fibrillation report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.
  • Atrial Fibrillation pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

SpectraWAVE Announces $13.2 Million Series A-2 Financing from Existing Investors to Bring Intracoronary Imaging Technology to Market

Retrieved on: 
Wednesday, February 3, 2021

today announced a $13.2 million Series A-2 financing to support completion of product development and regulatory filing for its flagship intracoronary imaging product, designed to help physicians optimize coronary stenting interventions and limit future adverse events.

Key Points: 
  • today announced a $13.2 million Series A-2 financing to support completion of product development and regulatory filing for its flagship intracoronary imaging product, designed to help physicians optimize coronary stenting interventions and limit future adverse events.
  • The funding round is led by prior investor Deerfield Management, and includes follow-on investment from prior unnamed seed investors.
  • In CAD, patients can undergo stent placement to relieve symptoms, but one in five patients can experience a major adverse event.
  • SpectraWAVE is developing a medical imaging platform that combines two state-of-the-art technologies providing high resolution plaque structure and content in coronary blood vessels.

Genomic Advances in Heart Failure, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Tuesday, February 2, 2021

Despite significant research into the drivers of heart failure, many patients remain undiagnosed or poorly managed and new therapies are needed.

Key Points: 
  • Despite significant research into the drivers of heart failure, many patients remain undiagnosed or poorly managed and new therapies are needed.
  • This webinar will cover recent advances in heart failure genomics with a focus on translating findings into improved therapeutics and diagnosis.
  • For heart failure, these datasets help scientists discover and validate new drug targets for heart failure and are enriched with participants with HFpEF.
  • For more information, or to register for this event, visit Genomic Advances in Heart Failure.

Cardio Diagnostics Launches Epi+Gen CHD™, A New Heart Disease Risk Assessment Test

Retrieved on: 
Thursday, January 28, 2021

Primary care clinicians currently have only two tools: the Framingham Risk Score (FRS), and the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator, for predicting future heart disease.

Key Points: 
  • Primary care clinicians currently have only two tools: the Framingham Risk Score (FRS), and the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator, for predicting future heart disease.
  • Cardio Diagnostics flagship product focuses on risk for coronary heart disease because it is the most common type of heart disease, and the major cause of heart attacks.
  • Cardio Diagnostics Chief Executive Officer and Co-Founder, Meeshanthini (Meesha) Dogan Ph.D., shared we are incredibly excited about getting this early risk assessment test to the market.
  • Developed in partnership with a team of dedicated scientists and clinicians, the Cardio Diagnostics Epi+Gen CHD test helps clinicians better assess each patients unique risk profile for disease.