Circulatory system

Medtronic Announces Early Feasibility Trial for Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal Approach

Retrieved on: 
Friday, September 27, 2019
Medical specialties, Medicine, Cardiac surgery, Circulatory system, Cardiology, Mitral valve replacement, Regurgitation, Mitral valve, Valvular heart disease, Mitral insufficiency, Valve replacement, Heart valve

DUBLIN, Sept. 27, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) todayannounced it has received U.S. Food and Drug Administration (FDA) approval to begin an early feasibility study (EFS) for its Intrepid transcatheter mitral valve replacement (TMVR) system using a minimally-invasive transfemoral access approach.

Key Points: 
  • DUBLIN, Sept. 27, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) todayannounced it has received U.S. Food and Drug Administration (FDA) approval to begin an early feasibility study (EFS) for its Intrepid transcatheter mitral valve replacement (TMVR) system using a minimally-invasive transfemoral access approach.
  • The prospective, multi-center, non-randomized EFS will evaluate the safety and performance of the Intrepid TMVR System with the transfemoral approach in patients with severe, symptomatic mitral regurgitation (MR) who are ineligible for conventional mitral valve surgery.
  • Mitral regurgitation (MR) is the most common heart valve disease in the United States, affecting an estimated four million people.
  • Medtronic believes that transcatheter mitral valve replacement will have a vital role in treating patients with mitral valve diseaseand this early feasibility study is another step forward in our Intrepid program, said Nina Goodheart, vice president and general manager, Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic.

SVS: 5 things you need to know about leg artery disease

Retrieved on: 
Wednesday, September 25, 2019
Cardiovascular system, Circulatory system, Angiology, RTT, Vascular diseases, Cardiovascular physiology, Peripheral artery disease, Atherosclerosis, Artery, Heart diseases, Macrovascular disease

ROSEMONT, Ill., Sept. 25, 2019 /PRNewswire/ --Between 12 and 20 percent of Americans over age 60 have peripheral arterial disease (also called PAD or leg artery disease).

Key Points: 
  • ROSEMONT, Ill., Sept. 25, 2019 /PRNewswire/ --Between 12 and 20 percent of Americans over age 60 have peripheral arterial disease (also called PAD or leg artery disease).
  • The disease, which is caused by atherosclerosis, or hardening of the arteries, becomes much more prevalent with age.
  • It may never progress beyond the mild stage, but it also could lead to a deadly conclusion.
  • Here are some important facts to know and share:
    Who gets PAD?

PPMD Awards University of Florida $1 Million for Novel Gene Therapy Approach Targeting the Heart

Retrieved on: 
Tuesday, September 17, 2019
RTT, Anatomy, Branches of biology, Cardiomyopathy, Circulatory system, Dilated cardiomyopathy, Cardiac muscle, Coxsackievirus-induced cardiomyopathy, Duchenne muscular dystrophy

The absence of dystrophin in the heart contributes to a progressive deterioration of cardiac muscle and eventual dilated cardiomyopathy (DCM) or heart disease.

Key Points: 
  • The absence of dystrophin in the heart contributes to a progressive deterioration of cardiac muscle and eventual dilated cardiomyopathy (DCM) or heart disease.
  • Gene therapy, utilizing AAV vector as the delivery vehicle, provides a potential strategy to deliver transgenes targeting the mechanisms underlying the development of dilated cardiomyopathy.
  • This funding supports the development of a heart specific therapy using an AAV vector containing two transgenes to restore calcium handling and prevent mitochondrial dysfunction.
  • Chris and Patrick died of heart failure, so the heart is at the center of Duchenne for me.

Familial Hypercholesterolemia Patients at High Risk for Cardiovascular Events Despite Treatment

Retrieved on: 
Tuesday, September 17, 2019
RTT, Branches of biology, Health, Circulatory system, Cardiovascular disease, Hypercholesterolemia, Cholesterol, Heart, Myocardial infarction, Familial hypercholesterolemia, Coronary artery disease

"These data suggest that FH patients without known heart disease may actually have a risk of heart attack that is comparable to the risk in patients without FH who have already had a heart attack.

Key Points: 
  • "These data suggest that FH patients without known heart disease may actually have a risk of heart attack that is comparable to the risk in patients without FH who have already had a heart attack.
  • While cardiovascular event rates were high overall, rates of major cardiovascular events were almost six times higher among individuals with prior cardiovascular disease compared to those without.
  • FH is a common genetic condition that causes very high cholesterol and can lead to early heart disease if untreated.
  • Our mission is to save lives by contributing to scientific research that leads to greater understanding and improved diagnosis and treatment of FH worldwide.

SMILE Heart Failure Clinical Trial Primary Results Presented at HFSA 2019

Retrieved on: 
Monday, September 16, 2019
Anatomy, RTT, Circulatory system, Cardiovascular system, Heart diseases, Healthcare quality, Organ failure, Cardiovascular diseases, Hospital readmission, Heart failure, Management of heart failure, Heart

PHILADELPHIA, Sept. 16, 2019 /PRNewswire/ --Today at the Heart Failure Society of America Annual Meeting Dr. William T. Abraham the SMILE national principle investigator presented the results of the study as a late breaking trial.

Key Points: 
  • PHILADELPHIA, Sept. 16, 2019 /PRNewswire/ --Today at the Heart Failure Society of America Annual Meeting Dr. William T. Abraham the SMILE national principle investigator presented the results of the study as a late breaking trial.
  • The study examined use of ReDS non-invasive remote monitoring of pulmonary congestion for the management of heart failure patients.
  • The SMILE trial demonstrated that when used as intended, REDS-guided heart failure management prevented 58% of heart failure readmissions.
  • "When ReDS measurements are taken regularly by patients and physicians use this information to guide therapy, the SMILE trial demonstrates a reduction in hospital readmissions for heart failure."

FDA Grants Fast Track Designation for FARXIGA in Heart Failure

Retrieved on: 
Monday, September 16, 2019
FDA, Diabetes, Clinical trials, Cardiology, Biotechnology, Pharmaceutical, Health, Heart diseases, Cardiovascular system, Anatomy, Circulatory system, Organ failure, RTT, Bristol-Myers Squibb, Chloroarenes, Dapagliflozin, Heart failure with preserved ejection fraction, Heart failure, Ejection fraction, heart failure, the DapaCare Clinical Program, AstraZeneca in CV, Renal & Metabolism (CVMD), AstraZeneca

This Fast Track designation for FARXIGA brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure, and we look forward to working with the FDA to explore FARXIGA as a potential new treatment option for heart failure patients.

Key Points: 
  • This Fast Track designation for FARXIGA brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure, and we look forward to working with the FDA to explore FARXIGA as a potential new treatment option for heart failure patients.
  • The Fast Track designation is based on two Phase III trials, DAPA-HF and DELIVER, which investigated the role of FARXIGA in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively.
  • In August 2019 the FDA granted Fast Track designation for the development of FARXIGA to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease.
  • Heart failure (HF) is a life-threatening disease in which the heart cannot pump enough blood around the body.

Ancora Heart Announces Key Activities for Transcatheter Cardiovascular Therapeutics 2019

Retrieved on: 
Monday, September 16, 2019
Health, Medical devices, Clinical trials, Cardiology, Biotechnology, Cardiovascular diseases, Cardiology, Circulatory system, Valvular heart disease, Heart diseases, RTT, Heart failure, Organ failure, Mitral insufficiency, Mitral valve

Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced the companys key activities at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation in San Francisco.

Key Points: 
  • Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced the companys key activities at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation in San Francisco.
  • Ancora Hearts primary TCT conference activities include:
    Hypertension and Heart Failure Therapies: Session II: Heart Failure Therapies, TCT 88: Six Month Outcomes of an Early Feasibility Study of the AccuCinch Left Ventricular Repair System in Patients with Heart Failure and Functional Mitral Regurgitation
    Presented by Satya Shreenivas, M.D.
  • Ancora Heart, Inc., based in Santa Clara, Calif., is dedicated to helping people with heart failure feel better and live longer.
  • Ancora Heart has developed the AccuCinch system, an investigational therapy designed to repair the enlarged left ventricle targeting the underlying cause of heart failure.

Sensible Medical announces ReDS™ Pro, the next generation of market leading lung fluid management technology for heart failure

Retrieved on: 
Saturday, September 14, 2019
Anatomy, RTT, Heart diseases, Cardiovascular system, Organ failure, Heart failure, Congestion, Heart, Pulmonary edema, Circulatory system

ReDSTM PRO utilizes non-invasive low energy RF technology that produces reliable fluid volume readings after 45 seconds of measurement.

Key Points: 
  • ReDSTM PRO utilizes non-invasive low energy RF technology that produces reliable fluid volume readings after 45 seconds of measurement.
  • "ReDS is a valuable tool for assessment of my heart failure patients' pulmonary congestion," said Dr. Daniel Bensimhon, Medical Director of the Advanced Heart Failure and Mechanical Circulatory Support Program at Cone Health System in Greensboro, NC.
  • "We are very excited to launch the ReDS Pro system here at HFSA," said Amir Ronen, Sensible Medical CEO.
  • Expanding the accessibility to ReDS monitoring technology to help improve heart failure care is our goal and our passion."

Rex Medical Receives 510k Clearance for Revolution™ Peripheral Atherectomy System

Retrieved on: 
Thursday, September 12, 2019
Oncology, Medical devices, Other Manufacturing, Clinical trials, Surgery, Cardiology, FDA, Health, Manufacturing, Medical specialties, Circulatory system, Medicine, Vascular surgery, Interventional radiology, Atherectomy, RTT, Vascular diseases, Thrombus, Atherosclerosis, Peripheral vascular system, Revascularization

Rex Medical, L.P. , a medical device design and development company, today announced that it has received 510k Clearance from the U.S. Food and Drug Administration (FDA) for the Revolution Peripheral Atherectomy System.

Key Points: 
  • Rex Medical, L.P. , a medical device design and development company, today announced that it has received 510k Clearance from the U.S. Food and Drug Administration (FDA) for the Revolution Peripheral Atherectomy System.
  • The results of this pivotal trial demonstrated the safety and effectiveness of the Revolution Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization in 121 subjects with femoropopliteal/tibial occlusive disease.
  • The Revolution device is indicated for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.
  • The Rex Medical Revolution Peripheral Atherectomy System is an innovative and ergonomically designed low profile rotational atherectomy system (140,000 RPM) with continuous mechanical aspiration for below-the-knee (BTK) and above-the-knee (ATK) applications including multiple plaque morphologies ranging from thrombus and soft plaque to severely calcified lesions and chronic total occlusions (CTOs).

HeartFlow Announces FDA Clearance for HeartFlow Planner

Retrieved on: 
Thursday, September 12, 2019
FDA, Mobile, Wireless, Technology, Health, Medical devices, Software, Hospitals, Internet, Data management, Cardiology, Circulatory system, Cardiovascular system, Medical specialties, Coronary artery disease, RTT, Coronary circulation, Coronary, Artery disease, the HeartFlow FFRct Analysis and HeartFlow Planner, HeartFlow, Inc.

HeartFlow, Inc. today announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner , a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention.

Key Points: 
  • HeartFlow, Inc. today announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner , a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention.
  • The HeartFlow Planner is a pre-procedure planning tool that is based on an idealized model of the HeartFlow Analysis, a color-coded 3D model of a patients coronary arteries.
  • HeartFlow will be showcasing the HeartFlow Planner at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting taking place in San Francisco, September 25-29, Booth # 2343.
  • The HeartFlow Planner utilizes an idealized coronary anatomy model and physiology simulation created from the HeartFlow Analysis.