Coronary/Structural Heart

Catasys’ Telehealth-Enabled OnTrak™ Programs See Surge in Enrollment and Engagement Amidst COVID-19 Pandemic

Customer Expansions Continue as Effective Outreach Pool Climbs to 145,000, Up 34% from Q4 2019 SANTA MONICA, Calif.–(BUSINESS WIRE)–Catasys, Inc. (NASDAQ: CATS) (“Catasys” or the “Company”), a leading AI-powered and telehealth-enabled, virtualized outpatient healthcare treatment company, today announced that the Company is surpassing a weekly rate of 500 member enrollments for the […]

Foldax® Completes Enrollment in Tria LifePolymer™ Early Feasibility Study

Company demonstrates excellent progress in its surgical aortic heart valve study SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that it has completed initial enrollment in its early feasibility study (EFS) for the Tria LifePolymer™ heart valve. Fifteen patients have been enrolled in 4 participating sites. “The study is progressing well and we […]

MCRA Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

WASHINGTON, March 24, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device advisory firm and CRO with specialization in regulatory affairs, clinical research, reimbursement, compliance, and quality assurance, has implemented a call center to keep medical device manufacturers informed of government and site decisions that impact regulatory submissions, clinical study operations, or quality […]

CHF Solutions’ Aquadex FlexFlow® System is licensed and approved for sale in India

EDEN PRAIRIE, Minn., March 19, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced the Aquadex FlexFlow system has been licensed and approved for sale in India, making ultrafiltration therapy available for patients suffering from hypervolemia, or fluid overload, in one of the largest countries in the world. “We […]

Novartis announces NEJM publication of three pivotal trials showing durable and potent efficacy of inclisiran, an investigational first-in-class siRNA cholesterol-lowering therapy

– Inclisiran, an investigational medicine, showed durable and potent reduction of low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalents and heterozygous familial hypercholesterolemia (HeFH)[1,2] – Inclisiran reduced LDL-C at 17 months by 52% in patients with ASCVD (ORION-10), 50% for ASCVD and ASCVD risk […]

Tenax Therapeutics Completes Enrollment in Phase 2 Pulmonary Hypertension Trial

HELP study exceeds target enrollment with 37 patients 84% initial open-label lead-in response rate to qualify for randomization Pulmonary capillary wedge pressure (PCWP) was reduced, on average, by 7.5 mmHg during exercise following the initial levosimendan infusion No serious drug-related adverse events have been reported to date Top-line data expected […]

Paragonix Technologies, Inc., Announces AdventHealth’s Adoption of Paragonix SherpaPak™ Cardiac Transport System

Paragonix SherpaPak™ Cardiac Transport System is the only FDA cleared and CE marked device that safeguards hearts between donor and recipient patients CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced AdventHealth (Orlando, Florida) has adopted its Paragonix SherpaPak™ Cardiac Transport System (CTS) for the preservation of donor hearts for transplantation. A recent […]

Mentice Expands Coronary Product Portfolio with the Introduction of Coronary Intermediate Software

STOCKHOLM, March 12, 2020 /PRNewswire/ — Mentice AB (STO: MNTC), a world leader in simulation solutions for endovascular therapies, introduces Coronary Intermediate as the latest software addition to the Coronary Product Portfolio. Coronary Intermediate follows the introduction of Coronary Essentials three months earlier at the 20th International Meeting on Simulation in Healthcare […]

NuVera Medical Wins Cardiology2.0 Magazine’s "Top 25 Cardiac Imaging Leaders 2020" Honor

LOS GATOS, Calif., March 12, 2020 /PRNewswire/ — NuVera Medical, Inc., a portfolio company of Shifamed LLC, has been awarded the “Top 25 Cardiac Imaging Leaders 2020” honor from Cardiology2.0 Magazine as recognition for the impact the company is making in the cardiac imaging space. “NuVera is reinventing the imaging modality for complex […]