The Latest Cardiac and Vascular News
Bloomington, Ind. — Cook Medical’s Zenith® Fenestrated+ Endovascular Graft (ZFEN+) product has received Breakthrough Device designation from the US Food and Drug Administration (FDA). This designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. While the […]
TEL AVIV, Israel, March 1, 2021 /PRNewswire/ — Vascular Grafts Solutions (VGS) Ltd. announced today receipt of marketing clearance from the Food and Drug Administration (FDA) for the VIOLA™, a new device for clampless proximal anastomosis in coronary artery bypass grafting (CABG) Neurocognitive dysfunction remains the most devastating perioperative complication of CABG […]
PORTLAND, Ore., Feb. 23, 2021 /PRNewswire/ — Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR® heart failure management system. The system uses clinically tested algorithms to detect the risk of decompensation at home in patients who have been previously hospitalized for heart failure. […]
20-vial pack provides a green packaging alternative and helps increase storage efficiency MONROE TOWNSHIP, N.J., Feb. 22, 2021 /PRNewswire/ — Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world’s leading companies in the diagnostic imaging business, announced today that its ultrasound enhancing agent (UEA) LUMASON® (sulfur hexafluoride lipid-type […]
Transformative Technology Now Available for Calcified Coronary Plaque SANTA CLARA, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the company’s sonic pressure wave therapy received Pre-Market Approval for […]
Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3 Expanded indication enables potential treatment of more adults with […]
FREMONT, Calif. and OXFORD, United Kingdom, Feb. 11, 2021 /PRNewswire/ — Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System™. Breakthrough Device Designation is granted to medical devices and device-led combination products […]
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 […]
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 […]
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 […]
