BRISBANE, Australia & MINNEAPOLIS–(BUSINESS WIRE)– Anteris Technologies Ltd (Anteris or the Company) (ASX: AVR, OTC: ANTTY) reported today that DurAVR™ THV, a new class of biomimetic heart valve and the world’s only balloon-expandable, single-piece transcatheter aortic valve was implanted in a second successful Valve-in-Valve (ViV) procedure as part of Health Canada’s Special […]
Coronary/Structural Heart
Anteris Technologies Commences US Early Feasibility Study
BRISBANE, Australia & MINNEAPOLIS–(BUSINESS WIRE)–Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR, OTC: ANTTY) reported today that DurAVR™ Transcatheter Heart Valve (THV), a new class of biomimetic valve and the world’s only biomimetic, single-piece transcatheter aortic valve, was used to successfully to treat patients as part of the DurAVR™ […]
Novo Nordisk A/S: Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the SELECT trial
Bagsværd, Denmark, 8 August 2023 – Novo Nordisk today announced the headline results from the SELECT cardiovascular outcomes trial. The double-blinded trial compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to standard of care for prevention of major adverse cardiovascular events (MACEs) over a period of up to five years. […]
Orchestra BioMed™ Granted FDA Approval of IDE for U.S. Pivotal Study of Virtue® Sirolimus AngioInfusion Balloon™ in Patients with Coronary In-Stent Restenosis
NEW HOPE, Pa., Aug. 08, 2023 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the U.S. Food and Drug Administration (the “FDA”) granted investigational device exemption (“IDE”) approval with conditions […]
VenusP-Valve granted IDE approval for clinical trial, unveiling a new chapter for Chinese valve solutions globally
HANGZHOU, China, Aug. 6, 2023 /PRNewswire/ — Recently, Venus Medtech (Hangzhou) Inc. (“Venus Medtech”), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced the Investigational Device Exemption (IDE) full approval for its in-house developed VenusP-Valve from the U.S. Food and Drug Administration (FDA). VenusP-Valve, thus, has become the […]
Lilly’s Retevmo® (selpercatinib) is the First Targeted Therapy to Demonstrate Superior Progression-Free Survival Compared to a PD-1 Inhibitor Plus Chemotherapy for Adults with Newly-Diagnosed Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
INDIANAPOLIS, Aug. 4, 2023 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced topline results from the LIBRETTO-431 study evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed – with or without pembrolizumab – as an initial treatment for patients with rearranged during transfection (RET) fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC). The study met […]
Results from XyloCor Therapeutics’ Phase 1 Portion of EXACT Trial of XC001 for Cardiovascular Disease Published in Circulation: Cardiovascular Interventions
WAYNE, Pa.–(BUSINESS WIRE)–XyloCor Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, announced today that Circulation: Cardiovascular Interventions has published results from the Phase 1 portion of its Phase 1/2 clinical trial (EXACT) of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina. The findings […]
Cardio Diagnostics Holdings, Inc Announces Expansion of IP Portfolio in Australia with Notice of Allowance of Patent Application
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc (Nasdaq: CDIO), a pioneer of artificial intelligence-driven precision cardiovascular medicine tests, today announced that Australia’s Patent Office has issued a Notice of Allowance to the University of Iowa Research Foundation (“UIRF”) for Australian Patent Application No. 2017277666, titled “Compositions and Methods for Detecting Predisposition to Cardiovascular […]
Alucent Biomedical Wins FDA Approval for U.S. Clinical Study
SALT LAKE CITY–(BUSINESS WIRE)–Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology. “AlucentNVS technology is poised to change the standard of care in treating patients undergoing life- and […]
Teleflex Receives FDA Clearance for Expanded Indication for QuikClot Control+™ Hemostatic Device Usage in Cardiac Surgical Procedures
WAYNE, Pa., Aug. 01, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the U.S Food and Drug Administration (FDA) has cleared the QuikClot Control+™ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a […]
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