Coronary/Structural Heart

Imbria Pharmaceuticals Completes Enrollment in the Phase 2 IMPROVE-ISCHEMIA Clinical Trial of Ninerafaxstat in Patients with Stable Angina

BOSTON, Aug. 16, 2023 (GLOBE NEWSWIRE) — Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company dedicated to developing innovative therapies designed to improve patient symptoms and function by enhancing cellular energetics, today announced that it has completed enrollment in the IMPROVE-ISCHEMIA Phase 2 placebo-controlled clinical trial of the investigational therapy, […]

Viz.ai Receives First De Novo Approval by the FDA for Hypertrophic Cardiomyopathy AI Algorithm

SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received a De Novo approval by the U.S. Food and Drug Administration (FDA) for its Viz HCM module, a hypertrophic cardiomyopathy (HCM) artificial intelligence (AI) detection algorithm, creating a new regulatory category for […]

CytoSorbents Completes U.S. and Canadian STAR-T Pivotal Trial

PRINCETON, N.J., Aug. 14, 2023 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has completed the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial, following the last scheduled patient follow-up.  The […]

DurAVR™ THV Demonstrates Exceptional Results in Second Valve-in-Valve Case

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 […]

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 […]