Patented SelectFlex™ Technology allows operators to achieve the ideal balance of trackability and support on demand to navigate complex neurovasculature System enables biaxial approach, regardless of access site, to eliminate complexity and cost of conventional configurations FREMONT,…
Regulatory
Corvia Medical Achieves CE Certification for Atrial Shunt Under New EU MDR Standards
Commercial validation in Europe parallels ongoing RESPONDER-HF clinical trial TEWKSBURY, Mass., Dec. 20, 2024 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure, announced today that it has achieved CE certification for the Corvia®…
SUPIRA MEDICAL INITIATES U.S. EARLY FEASIBILITY STUDY (EFS) FOR HIGH-RISK PCI
Company expands clinical program beyond 70 patients already treated in South America FIH and Feasibility Studies. FDA acknowledged potential benefits of the Supira System by granting the company a review pathway under the Breakthrough Device Program. Results from EFS will be used to support submission to FDA for Supira’s pivotal […]
Johnson & Johnson MedTech Receives IDE Approval for OTTAVA™ Robotic Surgical System
Company prepares to support clinical trial in the United States NEW BRUNSWICK, N.J., Nov. 12, 2024 /PRNewswire/ — Johnson & Johnson MedTech, a global leader in cardiovascular, orthopaedic, surgery and vision solutions, today announced that the U.S. Food & Drug Administration (FDA) has…
FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
MOUNTAIN VIEW, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that the U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of its next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD.
VANTIS VASCULAR RECEIVES FDA CLEARANCE FOR ITS CROSSFAST™ GUIDE EXTENSION SYSTEM
First and Only Dual Monorail Microcatheter System Purpose-Built for Complex Coronary and Peripheral Interventions SAN JOSE, Calif., Oct. 25, 2024 /PRNewswire/ — Vantis Vascular, Inc., a pioneering medical technology company founded by physicians with a passion to revolutionize vascular…
Medtronic receives CE Mark for Evolut™ FX+ TAVI system for treatment of symptomatic severe aortic stenosis
Medtronic plc, a global leader in healthcare technology, today announced it has received CE (Conformité Européenne) Mark for the Evolut™ FX+ transcatheter aortic valve implantation (TAVI) system, the company’s latest Evolut TAVI system for the treatment of symptomatic severe aortic stenosis. This follows the recent United States Food and Drug […]
Pi-Cardia Receives FDA Market Clearance for ShortCut™
REHOVOT, Israel–(BUSINESS WIRE)–Pi-Cardia Ltd., a global leader in the development of leaflet modification solutions for treating heart valves, announced today that the United States Food and Drug Administration (FDA) provided market clearance for ShortCut™ – the world’s first dedicated leaflet modification device, enabling valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures […]
Astellas Announces FDA Listing of DIGITIVA™ for the Management of Heart Failure
– New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring – TOKYO, Sept. 18, 2024 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced…
Piccolo Medical, Inc. Receives FDA Clearance for ECGuide™ Catheter Guidance Technology
SAN FRANCISCO, Sept. 16, 2024 /PRNewswire/ — Piccolo Medical, Inc. (Piccolo) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its innovative catheter guidance technology, the PM2™ System with ECGuide™ Connector. This technology…