Coronary/Structural Heart

Family Heart Foundation Study Shows Some Children With Homozygous Familial Hypercholesterolemia Miss out on Decades of Life-Saving Treatment

Only Children with the Most Severe HoFH are Diagnosed Before Adulthood, Putting those Not Identified Early at Risk for Heart Disease at a Young Age Findings presented in poster at AAP National Conference ANAHEIM, Calif.–(BUSINESS WIRE)–The Family Heart Foundation, a leading research and advocacy organization, shared results from an analysis of patients […]

Endologix Submits Premarket Approval (PMA) Application to FDA for the DETOURTM System.

 FDA to Review First-of-Its-Kind Percutaneous Femoropopliteal Bypass System IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives by providing disruptive therapies for the interventional treatment of vascular disease, today announced the submission of a Premarket Approval (PMA) application requesting approval for the DETOUR System to […]

ELANA® Heart Bypass Solution shows promising preliminary results in first-in-human trials

Results now available for the first 10 patients being treated with the ELANA open heart bypass solution as part of a SAFE-CAB trial. ELANA Heart Bypass Solution shown to be safe and feasible in humans, with all candidates free of Major Adverse Cardiovascular Events (MACE) at post-operative day 30. This trial […]

UPDATE – scPharmaceuticals Announces FDA Approval of FUROSCIX® (furosemide injection), the First and Only Self-administered, Subcutaneous Loop Diuretic for the At-home Treatment of Congestion in Chronic Heart Failure

FUROSCIX demonstrated 99.6% bioavailability and produced similar diuresis and natriuresis compared to intravenous furosemide Commercial launch planned in Q1 2023 BURLINGTON, Mass., Oct. 10, 2022 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of […]

Positive Data Presented at HFSA Annual Meeting Demonstrate Effects of Oral Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

MORRISVILLE, N.C., Oct. 10, 2022 (GLOBE NEWSWIRE) — Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announces the presentation of positive data from a study of PH-HFpEF patients being treated with […]

Merck Announces Positive Top-line Results from Pivotal Phase 3 STELLAR Trial Evaluating Sotatercept for the Treatment of Adults with Pulmonary Arterial Hypertension (PAH)

Sotatercept demonstrated significant improvement in exercise capacity and key secondary outcome measures compared to placebo when added to background therapy RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive top-line results from the pivotal Phase 3 STELLAR trial evaluating the safety […]

Valbiotis Accelerates Its Marketing Strategy

Internationally, the signing of licensing or distribution partnerships with major players in nutrition and healthcare. In France, Valbiotis has chosen to internalize its commercial operations for direct distribution, in order to generate rapid turnover and to ensure an independent and value-creating source of income. Continued structuring and R&D efforts on […]

Fourth Generation CathWorks FFRangio® System Receives Regulatory Approval in Japan

KFAR-SABA, Israel and IRVINE, Calif., Oct. 6, 2022 /PRNewswire/ — CathWorks announced today the approval of the fourth generation CathWorks FFRangio® System by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The FFRangio System is also commercially available in the United States and Europe. “The FFRangio System enables us to quickly perform a comprehensive physiologic assessment of coronary artery […]

From heart failure to heartfelt success IEHP Program Sustains Life for I.E. Woman

RANCHO CUCAMONGA, Calif., Oct. 6, 2022 /PRNewswire/ — After treatment and discharge from the emergency room (ER) for congestive heart failure complications, Inland Empire Health Plan (IEHP) member Lavinia experienced panic and anxiety attacks that compounded her heart issues and led to more hospital visits. IEHP team members identified Lavinia’s specialized needs […]