Coronary/Structural Heart

FDA grants “Breakthrough Device Designation” to CorFlow Therapeutics to expedite clinical development and regulatory review of its CoFI™ (COF-fee) System

BAAR, Switzerland–(BUSINESS WIRE)–CorFlow Therapeutics AG (www.corflow-therapeutics.ch) today announced that the FDA has designated the company’s CoFI (CorFlow Controlled Flow Infusion) System as a “Breakthrough Device” with a broad indication-for-use statement: “The CoFI™ System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), and to be a platform for controlled infusion of therapeutic agents […]

Heart MRI Delivers Accurate Diagnosis and Helps Guide Treatment of Cardiovascular Diseases

MOUNT ROYAL, N.J., Oct. 22, 2019 /PRNewswire/ — A recent study published in the New England Journal of Medicine supports the use of heart magnetic resonance imaging (Heart MRI) for improved diagnosis and treatment of patients with chest pain. Heart MRI is a non-invasive method for providing a complete visual evaluation of the anatomy and […]

MedHub’s AI-powered Solutions Are Disrupting Cardiology

The software company is commencing its pivotal multi-center clinical trial, aimed at demonstrating the efficacy of its ground-breaking product – AutocathFFR TEL AVIV, Israel, Oct. 22, 2019 /PRNewswire/ — MedHub develops decision-support systems for cardiologists that leverage Artificial Intelligence (AI) to guide cardiologists during the diagnostic cardiac angiography process. The fully automated […]

Medicure Announces SMILE™-HF Study Demonstrates Use of ReDS™ Results in 58% Reduction in Hospital Readmission Rate

WINNIPEG, Oct. 15, 2019 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company”) (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the primary results of the late-breaking SMILETM-Heart Failure (SMILE-HF) Clinical Trial which was presented at the recent Heart Failure Society of America (“HFSA”) conference in Philadelphia, PA by Dr. William T. Abraham, the […]

Neovasc Announces Notice of US Patent Granted for Tiara™ Transcatheter Device for Treatment of Severe Mitral Regurgitation

VANCOUVER, Oct. 15, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that the United States Patent […]

CHF Solutions Announces that James A. Haley Veterans’ Hospital Receives Final Approval To Initiate Heart Failure Outpatient Study utilizing Aquadex FlexFlow® System

First Study of Aquadex FlexFlow System Sponsored by United States Veterans Administration for Aquapheresis Treatment in Patients Suffering from Fluid Overload. First patient enrollment expected in the fourth quarter of 2019. EDEN PRAIRIE, Minn., Oct. 10, 2019 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), today announced that James A. Haley […]

PENUMBRA ANNOUNCES FIRST PATIENT ENROLLED IN STUDY OF MECHANICAL POWER ASPIRATION FOR THROMBUS REMOVAL IN CORONARY VESSELS

Prospective Study to Evaluate Safety and Performance of Indigo® System and CAT RX Aspiration Catheter ALAMEDA, Calif. – October 10, 2019 – Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced enrollment of the first patient into the CHEETAH study, a prospective, multi-center U.S. study to […]

FDA Classifies Medtronic Sherpa Delivery Catheter Field Action Initiated in March 2019 as Class I Recall

DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s voluntary field action initiated in March 2019 related to the 6F Sherpa™ NX Active Coronary Guide Catheter as a Class I recall. The catheter is used during coronary […]

Corvia Medical’s Interatrial Shunt Device (IASD®) Receives Breakthrough Device Designation For Heart Failure

TEWKSBURY, Mass., Oct. 9, 2019 /PRNewswire/ — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its InterAtrial Shunt Device (IASD) for heart failure. The IASD is […]

BioVentrix Enrolls and Treats First Patient in REVIVE-HF European RCT for Ischemic Heart Failure Patients

SAN RAMON, Calif., Oct. 8, 2019 /PRNewswire/ — BioVentrix, Inc. announced the first patient was enrolled and treated  in the REVIVE-HF European  study, a prospective multi-center, dual-arm randomized controlled study evaluating the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TCTM System compared to Guideline-Directed Medical Therapy (GDMT) or drug treatment. The  patient […]