The Latest Cardiac and Vascular News
TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ — Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C) In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced LDL-C by nearly half at 24 […]
First enrollment in the study expected in Q1 2021 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today provides […]
MONTREAL, Feb. 8, 2021 /PRNewswire/ – Puzzle Medical Devices Inc., (www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure. The FDA Breakthrough Device Program is intended to help patients receive more timely access […]
Expands portfolio across Health, Wellness and User Identification for deployment in consumer and medical technology sectors BELFAST, Northern Ireland–(BUSINESS WIRE)–B-Secur, a leader in EKG/ECG technology, today announced that it has received U.S. Food and Drug Administration (FDA) 510(K) clearance of its HeartKey® software library1. B-Secur’s HeartKey® is a suite of powerful […]
Clinical Trial Demonstrates Procedural Efficiencies, Safety, Effectiveness and Non-Inferiority of DiamondTemp System DUBLIN, Jan. 29, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of the DiamondTemp™ Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial […]
Innovative technology offers an implant-free approach for individuals with chronic heart failure AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology offers a no-implant interatrial […]
Novel perfusion monitor achieves FDA Breakthrough Device Designation for real-time, periprocedural monitoring of tissue perfusion in patients with critical limb threatening ischemia SINGAPORE, Jan 25, 2021 /PRNewswire/ — PEDRA™ Technology, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for the […]
11F mechanical thrombectomy system removes large blood clots in deep vein thrombosis (DVT) HALLANDALE BEACH, Flo., Jan. 22, 2021 /PRNewswire/ — Control Medical Technology announced the FDA cleared Control 11F Mechanical Thrombectomy system was used to remove large blood clots from patients with deep vein thrombosis (DVT). “Control removed large blood […]
Aquilion Exceed LB CT System Offers Industry’s Largest Bore and Widest Field-of-View TUSTIN, Calif.–(BUSINESS WIRE)–Canon Medical Systems USA, Inc. has received FDA clearance for the Aquilion Exceed LB™ CT system, giving clinicians the opportunity to see more during radiation therapy planning for accuracy, precision and speed. As cancer cases continue to […]
VERQUVO Approved for Reduction of Risk of Cardiovascular Death and Heart Failure (HF) Hospitalization Following a Hospitalization for HF or Need for Outpatient Intravenous (IV) Diuretics in Adults with Symptomatic Chronic Heart Failure and Ejection Fraction Less than 45% VERQUVO is the First Soluble Guanylate Cyclase Stimulator, Approved to Treat […]
