Coronary/Structural Heart

Tenax Therapeutics Gains North American Rights to Oral Levosimendan through Expanded License Agreement with Orion Corporation

Tenax gains developmental and commercial rights for a fully-developed oral levosimendan formulation in the U.S. and Canada Oral formulation expected to be used in upcoming Phase 3 registration trial MORRISVILLE, N.C.–(BUSINESS WIRE)–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical […]

Medtronic Launches Head-to-Head TAVR Study Comparing the Evolut™ TAVR Platform Against the Edwards SAPIEN Valve in Small Annulus Patients

Medtronic Also Begins Feasibility Study of Evolut TAVR System in Moderate and Asymptomatic Aortic Stenosis Patients DUBLIN, Oct. 14, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in structural heart therapies, today announced it will begin a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic […]

Results of the PROSPECT II Natural History Study Demonstrate High-Risk Plaques Identified by NIRS+IVUS Imaging are Linked to Future Coronary Events

PROSPECT ABSORB, a randomized substudy, showed treatment of high risk plaques with BVS is safe and associated with favorable long-term clinical outcomes compared to GDMT alone BEDFORD, Mass.–(BUSINESS WIRE)–Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced positive results from the PROSPECT II and […]

Medtronic Announces Partnership with The Foundry to Develop Innovative Mitral Valve Repair Technology

Half Moon Medical’s Technology Now Ready for Evaluation in Early Feasibility Study DUBLIN, Oct. 14, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced a partnership with The Foundry – a medical device company incubator – dating back to mid-2017 to invest in and create a company with the […]

Restore EF Study Demonstrates Impella-Supported High-Risk PCI Improves Left Ventricular Ejection Fraction

DANVERS, Mass.–(BUSINESS WIRE)–The Restore EF Study demonstrates the use of contemporary best practices, including attempting a more complete revascularization with Impella-supported high-risk PCI, is associated with significant improvement of left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at follow up. The interim analysis was presented today by Mitul […]

Large Study Demonstrates Exceptional Safety and High Procedural Success With Cardiovascular Systems’ Diamondback 360® Coronary Orbital Atherectomy System (OAS)

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that results from a large retrospective observational study of coronary orbital atherectomy were released at TCT Connect 2020. The presentation, authored […]

Foldax Named Cardiovascular Device Company of the Year by MedTech Outlook

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 […]

GE Healthcare Receives FDA Clearance for Vivid Ultra Edition, AI-Powered Cardiovascular Ultrasound System Designed to Shorten Diagnostic Exam Time and Improve Measurement Consistency

CHICAGO–(BUSINESS WIRE)–GE Healthcare today announced U.S. FDA 510k clearance for its Ultra Edition package on Vivid1 cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that enable clinicians to acquire faster, more repeatable exams consistently. Methodical assessments of heart function are key in echocardiography but can be tedious […]

CARMAT is granted €13 million in national innovation funding to conduct the EFICAS study in France

PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has been granted €13 million in funding […]

LivaNova Presents New Data at European Association for Cardio-Thoracic Surgery Annual Meeting Demonstrating Benefits of Perceval Sutureless Valve

New PERSIST-AVR study results and SURE-AVR registry data analysis underscore utility of Perceval as a minimally invasive surgical approach for patients with aortic valve stenosis LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) a market-leading medical technology and innovation company, today announced new data from the Perceval® Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR) clinical study and […]