Medtronic (NYSE:MDT) today announced new, long-term study data further supporting its Symplicity Spyral renal denervation (RDN) system. Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure to treat hypertension. These nerves can become overactive and contribute to high blood pressure. The RDN system holds approval for commercial use in more […]
Clinical Trials
HeartFlow data supports AI plaque analysis
HeartFlow announced positive seven-year data supporting the use of its AI-enabled fractional flow reserve computed tomography (FFRCT) and Plaque Analysis. This study assessed long-term risk of coronary artery disease (CAD) in clinically stable, symptomatic patients. Outcomes showed that the HeartFlow platform provides clinicians with the insights needed to anticipate and mitigate adverse events. That includes myocardial infarctions […]
Edwards data highlights superiority of early TAVR intervention
Edwards Lifesciences (NYSE:EW) today announced positive results from a study aiming to evaluate the benefits of early TAVR intervention. Investigators presented data from the transcatheter aortic valve replacement (TAVR) study at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C. Findings from the EARLY-TAVR trial were published simultaneously in The New England Journal of Medicine. Edwards’ trial […]
Johnson & Johnson has positive Impella ECP heart pump data
Johnson & Johnson MedTech reported positive data for the Abiomed Impella ECP transvalvular axial flow pump with compressible pump architecture. Investigators presented results at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C. Dr. Amir Kaki led the FDA IDE study — the first completed pivotal trial for Impella ECP — as principal investigator. J&J said […]
Shifamed’s Adona Medical initiates first-in-human interatrial shunt study
Shifamed‘s Adona Medical announced the successful first-in-human use of its novel interatrial shunt in patients with heart failure. Dr. George Khabeishvili performed the first cases in a study at the Tbilisi Heart and Vascular Clinic in the Republic of Georgia. U.S. heart failure experts Dr. Gagan Singh and Dr. Edris Aman supported the initial cases. […]
Corvia Medical has positive data for atrial shunt
Corvia Medical today announced three-year positive results from its clinical trial of its Corvia Atrial Shunt. The REDUCE LAP-HF randomized trial evaluated the safety and efficacy of an atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. The group of patients had no latent pulmonary vascular disease or a […]
Jupiter Endovascular reports first patient treated in U.S. study of Vertex pulmonary embolectomy system
Jupiter Endovascular today announced the first U.S. patient treated in its SPIRARE II U.S. pivotal study for the Vertex system. The first U.S. patient treated follows last month’s announcement of the first Vertex use in the SPIRARE I study in Poland. SPIRARE II evaluates the Vertex pulmonary embolectomy system in the treatment of acute pulmonary […]
BlueWind Medical reports positive data for tibial neuromod
BlueWind Medical today announced two-year data from the OASIS pivotal study of its implantable tibial neuromodulation (iTNM) system. Park City, Utah-based BlueWind said investigators presented data at the American Urogynecologic Society (AUGS) Pelvic Floor Disorders (PFD) Week 2024 in Washington, D.C., and the International Continence Society (ICS) 2024 Annual Meeting in Madrid. Data came from […]
Adagio has first case in IDE study for cryoablation tech
Adagio Medical (Nasdaq:ADGM) today announced the first completed procedure in an FDA IDE study of its VT cryoablation system. The company picked up FDA investigational device exemption (IDE) for the study of its VT cryoablation system in May. Laguna Hills, California-based Adagio also reported the first commercial procedures in Europe following CE mark approval at […]
Abbott kicks off new trial aiming to improve heart failure outcomes with CardioMEMS, HeartMate 3
Abbott (NYSE:ABT) announced today that it launched a new, first-of-its-kind clinical trial designed to help heart failure patients with advanced therapy options. The company plans to utilize its CardioMEMS HF system to identify advanced heart failure patients at high risk of mortality. This could then identify those who could benefit from a HeartMate 3 left […]
CroíValve reports first tricuspid coaptation valve implant as part of U.S. early feasibility study
CroíValve today announced the first patient treated with its Duo transcatheter tricuspid coaptation valve system in the TANDEM II study. TANDEM II, an early feasibility study in the U.S., evaluates Duo in the treatment of severe tricuspid regurgitation (TR). Duo works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous […]
