– Submitted four efficacy supplements seeking inclusion of CV risk reduction and expansion of LDL-C lowering – – Anticipated approvals in U.S. in the first half of 2024 – ANN ARBOR, Mich., June 01, 2023 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today announced that it has submitted Supplemental New Drug Applications (sNDA) to […]
Coronary/Structural Heart
Lundquist Institute Investigators Co-Author Paper in JAMA on Coronary Heart Disease (CHD) Risk Prediction
Drs. Jerome Rotter & Matt Budoff Study Shows that in Middle-aged to Older Adults the Coronary Artery Calcium Score Improved CHD Risk Discrimination Los Angeles, June 01, 2023 (GLOBE NEWSWIRE) — The Lundquist Institute (TLI) announced today that Jerome Rotter, MD, and Matthew Budoff, MD, two of TLI’s investigators, are […]
Valve Medical Announces Successful First-in-Human Implantation of Ultra-low Profile TAVR Valve in Israel
TEL AVIV, Israel, May 31, 2023 /PRNewswire/ — Valve Medical, a wholly owned subsidiary of Medinol Ltd. is pleased to announce today the successful First-in-Human (FIH) implantation of their advanced Transcatheter Aortic Valve Replacement (TAVR) system in Israel, introducing a revolutionary advancement in Structural Heart procedures with the world’s first modular valve. The […]
VESTECK CONTINUES TO HELP PATIENTS AROUND THE WORLD
WEST CHESTER, Pa., May 31, 2023 /PRNewswire/ — VESTECK, Inc. is excited to announce the successful completion of 7 Endovascular Aortic Repair (EVAR) clinical cases with the “SUTURE-TIGHT”™ device. Professor Dainis Krievins and Dr. Bao Bui, performed the 2 most recent EVAR procedures in Riga, Latvia, suturing EVAR grafts to the aorta with the “SUTURE-TIGHT”™ catheter. […]
Tenax Therapeutics Achieves Major Milestone as USPTO Grants Notice of Allowance for U.S. Patent Application Covering Use of Oral Levosimendan (TNX-103) in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Once granted, this patent will provide intellectual property protection until December 2040, and may qualify for additional U.S. patent term extension beyond 2040 There are currently no FDA approved treatments for PH-HFpEF, a condition affecting more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients […]
Revamp Medical secures Series A Funding to support clinical trials for its Doraya™ catheter for treating heart failure patients
NETANYA, Israel, May 30, 2023 /PRNewswire/ — Revamp Medical, Inc., a privately held clinical-stage medical technology company committed to developing solutions for Heart Failure congestion management, today announced closing of a Series A preferred stock financing led by KCK Medtech. Major existing investors Arkin and Accelmed also participated in the financing as well as Michael […]
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guidelines-recommended treatment pathways RARITAN, N.J., May 30, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson […]
LEXICON ANNOUNCES FDA APPROVAL OF INPEFA™ (SOTAGLIFLOZIN) FOR TREATMENT OF HEART FAILURE
INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to placebo in the SOLOIST-WHF […]
Novel Percutaneous Ventricular Assist Device Feasible in Patients Undergoing High-Risk Percutaneous Coronary Interventions (HRPCI)
First-of-its-Kind Low Profile, High Continuous Flow Device May Reduce Risk of Vascular Complications Associated with Current Devices Phoenix, AZ – Findings from the first-in-human trial of a novel percutaneous ventricular assist device (pVAD) were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific […]
European Study Finds the Abbott CardioMEMS Sensor Results in Improved Quality of Life and 44% Reduction in Heart Failure Hospitalizations
MONITOR-HF is the third randomized, controlled trial globally to show a significant health benefit for indicated heart failure patients CardioMEMS is a paperclip-sized sensor that can remotely flag to a patient’s clinical team the early warning signs of worsening heart failure ABBOTT PARK, Ill., May 24, 2023 /PRNewswire/ — New data presented […]



