The Latest Cardiac and Vascular News
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced the appointment of medical device veteran Scott Huennekens as an independent member of the company’s board of directors. Huennekens possesses more than 30 years of experience in the medical device industry, leading high-profile companies through IPOs and acquisitions, and serving on the board […]
Publication in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions Found TRIA Aortic Heart Valve Provided Sustained Improvement in Heart Valve Function to One-Year with Good Safety Profile SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced publication of the first clinical results for its TRIA™ biopolymer heart valve – […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the Drugs Controller General of India (DCGI), India’s regulatory body for medical devices, has approved initiation of a clinical trial of the TRIA™ biopolymer surgical aortic heart valve. The TRIA valve reimagines the heart valve by combining the company’s proprietary biopolymer – […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced completion of enrollment in the U.S. early feasibility study of the TRIA™ surgical aortic heart valve. The TRIA valve reimagines the heart valve by combining the company’s proprietary biopolymer – LifePolymer™ – with an innovative valve design intended to resist calcification, withstand stresses […]
Second Product from Tria Biopolymer Valve Portfolio to Move into Human Study SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced the successful first-in-human use of its biopolymer Tria™ heart valve in surgically replacing a diseased mitral valve. The first case was performed by David Heimansohn, MD, at Ascension St. Vincent Hospital, […]
Company’s LifePolymer Material Used in First Polymer Heart Valves Ever Approved by FDA for Use in Clinical Trials SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced publication of a research paper in Advanced NanoBiomed Research that concluded that its LifePolymer™ biopolymer “exhibits ideal biomaterial properties for the flexible leaflets of a totally synthetic […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval to expand the U.S. clinical study of the Tria™ surgical aortic heart valve. This next stage of enrollment is expected to begin within the next month. “We are excited to expand enrollment […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that it has been selected as Company of the Year among 10 cardiovascular device company finalists by MedTech Outlook Magazine. Foldax was honored for its innovative Tria™ heart valve, the first biopolymer heart valve to receive FDA approval for a U.S. clinical trial. Foldax has reinvented every […]
Tria Heart Valve Made with Proprietary LifePolymer Reimagines Material, Design and Manufacturing to Solve Long-Standing Heart Valve Issues SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that it has been selected as a finalist in the Fierce Innovation Awards – Life Sciences Edition 2020, a peer-reviewed awards program from the publisher of Fierce Biotech and Fierce Pharma, […]
