GENT, Belgium–(BUSINESS WIRE)–Data from the PRECISE-TAVI study, presented at the PCR Valves 2022 convention in London shows that Transcatheter Aortic Valve Implantation (TAVI) procedures planned by means of FEops HEARTguideTM result in an important change of pre-procedural decision making of the heart team, associated with favorable clinical outcomes. This prospective multicenter […]
Coronary/Structural Heart
EDWARDS ANNOUNCES ONE-YEAR DATA ON TRANSFEMORAL TRANSCATHETER TRICUSPID VALVE REPLACEMENT
LONDON, Nov. 27, 2022 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW) announced that one-year results on patients treated in the single-arm, prospective, global, multi-center TRISCEND study of the company’s EVOQUE transcatheter tricuspid valve replacement system demonstrated favorable safety, efficacy and quality-of-life outcomes. The data were presented during the late-breaking trials session at PCR London […]
Late-Breaking Post-Market Study Data Reinforce Clinical Procedural Success and Safety of the ACURATE neo2™ Aortic Valve System
MARLBOROUGH, Mass., Nov. 27, 2022 /PRNewswire/ — Boston Scientific Corporation (NYSE:BSX) has announced the first results from the ACURATE neo2 Post Market Clinical Follow-up (PMCF) study evaluating the performance of the ACURATE neo2TM Aortic Valve System. The findings, which included a high procedural success rate of 98.4% and low rates of mortality and paravalvular […]
Peijia Medical Limited and inQB8 Medical Technologies, LLC report Successful First-in-Human implantation of MonarQ Transcatheter Tricuspid Valve Replacement System
SUZHOU, China, Nov. 25, 2022 /PRNewswire/ — inQB8 Medical Technologies, LLC (inQB8), in Partnership with Peijia Medical Limited (Peijia, (9996.HK)), announced today that it has successfully implanted the MonarQ Transcatheter Tricuspid Valve in a 75-year-old female suffering from severe torrential Tricuspid Regurgitation. The Trans-Jugular TTVR procedure was performed on November 21, 2022, on compassionate grounds […]
Tenaya Therapeutics Receives Orphan Drug Designation from the U.S. Food and Drug Administration for its Gene Therapy for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy
TN-401 is being developed for the treatment of genetic arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by mutations in the PKP2 gene Orphan Drug Designation for TN-401 is the first for a gene therapy treatment for ARVC Expect to submit TN-401 IND application to the FDA in 2023 SOUTH SAN FRANCISCO, […]
CinCor Pharma Announces Topline Data for Phase 2 HALO Trial Evaluating Selective Aldosterone Synthase Inhibitor Baxdrostat in Uncontrolled Hypertension
Primary endpoint in Intention to Treat (ITT) was not met despite large absolute reductions in Systolic Blood Pressure (SBP) 12.6 mmHg placebo-adjusted reduction in SBP with 2 mg baxdrostat in a pre-specified subgroup that represents approximately 81-89% of the U.S. hypertension population (nominal p-value = 0.001) Safety profile and tolerability […]
Anteris Technologies Receives FDA Clearance to Initiate Early Feasibility Study for its Novel TAVR Product, DurAVR™
U.S. Clinical Trial Commencement Anticipated in 1Q2023 BRISBANE, Australia & EAGAN, Minn.–(BUSINESS WIRE)–Anteris Technologies Ltd (ASX: AVR), a structural heart company developing DurAVR™, the world’s only balloon-expandable, 3D single-piece aortic valve shaped to mimic the native human valve, today announced the U.S. Food and Drug Administration (FDA) has conditionally approved […]
Nyra Medical Announces $20 Million Series A Financing for its Transcatheter Heart Valve Repair Technology
Financing co-led by Vensana Capital and a Large, Global Medical Device Company Use of Proceeds to Advance Development of a Novel Catheter-based Solution for Mitral Regurgitation ATLANTA, Nov. 23, 2022 /PRNewswire/ — Nyra Medical, Inc., a medical device company that is developing a novel transcatheter mitral valve repair technology, today announced the […]
Acticor Biotech: World’s First Clinical Trial to Test New Drug Glenzocimab for Heart Attacks
PARIS–(BUSINESS WIRE)–Partnership between the University of Birmingham and Acticor Biotech (Paris:ALACT) will see patients with heart attacks treated with glenzocimab, a promising new class of drug for the first time. A potential new drug to improve the long-term outcomes for heart attack patients will be trialled in the UK. With the signing […]
CARMAT Announces the Resumption of Commercial Implants of its Aeson® Artificial Heart Is Now Effective
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 provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced that the resumption of commercial implants of its Aeson® artificial heart is now effective On October […]



