Regulatory

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. 

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 […]

Arch Biopartners Announces Alberta Health Services Approval to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI)

TORONTO, Sept. 11, 2024 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that Alberta Health Services (AHS) has approved the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).