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Top Cardiovascular News News

Foldax Secures Approval for TRIA Mitral Heart Valve in India
India · India

Foldax Secures Approval for TRIA Mitral Heart Valve in India

100% Center coverage: 1 sources
SALT LAKE CITY--(BUSINESS WIRE)--Jun 5, 2025-See the Story
Atraverse closes US$29 million to boost commercialisation of Hotwire transseptal access technology - Cardiovascular News
FDA · New York

Atraverse closes US$29 million to boost commercialisation of Hotwire transseptal access technology - Cardiovascular News

Atraverse Medical has announced the close of US$29.4 million in follow-on financing to accelerate growth, building upon the US$12.5 million in prior seed investment that was previously used to obtain US Food and Drug Administration (FDA) 510(k) clearance and begin early commercialisation of Hotwire—the company’s novel radiofrequency (RF) guidewire for left-heart access. Designed to simplify left-heart access through universal sheath compatibilit…Read Article
FastWave Medical Completes Initial Procedures In Study Of IVL System - Data Intelligence
Gainesville, Florida · Gainesville

FastWave Medical Completes Initial Procedures In Study Of IVL System - Data Intelligence

The company aims for the solution to obtain FDA approval. Credit: xmee/Shutterstock. FastWave Medical has completed the initial first-in-human procedures in the multicentre feasibility study of the Sola coronary laser intravascular lithotripsy (IVL) system. The study is designed to evaluate the performance and safety of Sola in individuals with calcified coronary artery disease. According to the company, this rupture-resistant balloon catheter a…See the Story

EuroPCR 2025: Thirty-day results show promise for Lux-Valve Plus TTVR system - Cardiovascular News

Thomas Modine Jenscare has announced the release of 30-day follow-up results of the TRINITY trial of the LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system, presented at EuroPCR 2025 (20–23 May, Paris, France) by Thomas Modine (CHU de Bordeaux, Bordeaux, France). TRINITY is a global prospective, multicentre, single-arm clinical trial, which primarily aims to evaluate the safety and efficacy of LuX-Valve Plus patients with sev…Paris, France · ParisRead Article

Surgical ablation during CABG carries survival advantage for patients with preexisting AF - Cardiovascular News

Medicare patients with atrial fibrillation (AF) who undergo surgical ablation during isolated coronary artery bypass grafting (CABG) live longer than those who do not, new research published in The Annals of Thoracic Surgery have shown. Researchers examined Medicare claims data from more than 87,000 patients with preexisting AF who underwent CABG between 2008 and 2019. Overall, only 22% of studied patients received concomitant surgical ablation …Medicare · United StatesRead Article

Trial of DCB and scaffold technologies enrols first CTO-PCI patients - Cardiovascular News

Biotronik has announced the enrolment of the first patient in the Leave Nothing Behind-trial, which aims to demonstrate the non-inferiority of drug-coated balloons (DCB) or DCBs in combination with resorbable magnesium scaffolds (RMS) compared to drug-eluting stents (DES) in chronic total occlusions (CTO) in percutaneous coronary interventions (PCI). The first implantation was performed by Mohamed Ayoub at the Heart and Diabetes Center North Rhi…Bad Oeynhausen · Bad OeynhausenRead Article

Boston Scientific ends TAVR sales; J&J shares Monarch robot data

100% Center coverage: 1 sources
Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory requirements.”Johnson & Johnson · BostonSee the Story

EuroPCR 2025: Myval shows promise in latest comparative studies against contemporary TAVI platforms - Cardiovascular News

Patrick W Serruys New data comparing the Myval transcatheter aortic valve implantation (TAVI) system (Meril Life Sciences) to contemporary TAVI platforms, have shown that the device continues to measure favourably against its competitor valves. One-year clinical and haemodynamic outcomes from the randomised LANDMARK trial were shared at EuroPCR 2025 (20–23 May, Paris, France)—comparing the balloon-expandable system to both Sapien (Edwards Lifesc…Paris, France · ParisRead Article

Abbott Receives FDA Approval for Tendyne™, First-of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery

60% Center coverage: 5 sources
The Tendyne system replaces mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves, known as severe mitral annular calcification (MAC)Tendyne offers a new treatment option for patients who are not…Fentanyl · United StatesSee the Story

Prevail DCB gains expanded CE mark indications - Cardiovascular News

Medtronic has received CE mark approval for several expanded indications for the treatment of coronary artery disease (CAD) with the Prevail paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter, or drug-coated balloon (DCB). The Prevail DCB now has the broadest range of CE Mark indications including bifurcation and is the only DCB indicated for treatment in patients with multivessel disease, acute coronary syn…Washington State · WashingtonSee the Story

EuroPCR 2025 hears early outcomes of Topaz TTVR system - Cardiovascular News

Julien Dreyfus TRiCares has announced the presentation of data in a late-breaking session at EuroPCR 2025 (20–23 May, Paris, France) from its first-in-human trial of the Topaz transcatheter tricuspid valve replacement (TTVR) system. Julien Dreyfus (Centre Cardiologique du Nord, Saint-Denis, France) presented 30-day post-procedural data from 20 tricuspid regurgitation (TR) patients treated with Topaz across eight specialist cardiac centres in Eur…Paris, France · ParisRead Article

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