Coronary/Structural Heart

Gradient Denervation Technologies Enrolls Initial Patient in First-In-Human Study of Pulmonary Artery Denervation Technology

Company plans Early Feasibility Study in the US for late 2023 PARIS, FRANCE / ACCESSWIRE / June 1, 2023 / Gradient Denervation Technologies, a Paris-based medical device company developing a minimally-invasive device for treating certain heart failure patients with associated pulmonary hypertension, announced today the successful first patient enrollment in its […]

Amarin Partner EddingPharm Receives Regulatory Approval for Vascepa® (Icosapent Ethyl) in Mainland China

 VASCEPA Approved by the National Medical Products Administration (NMPA) as an Adjunct to Diet to Reduce Triglyceride Levels in Adult Patients with Severe Hypertriglyceridemia (≥ 500 mg/dL) — — EddingPharm Now Working Towards Preparing for Commercial Launch of VASCEPA Across Mainland China Expected by Year-End — DUBLIN, Ireland and BRIDGEWATER, […]

Methodist Le Bonheur Healthcare’s Olive Branch Hospital is Among Nation’s Top Performing Hospitals for Treatment of Heart Attack Patients

 American College of Cardiology recognizes sustained, high-level performance in quality of care MEMPHIS, Tenn., June 1, 2023 /PRNewswire/ — The American College of Cardiology recognizes Methodist Le Bonheur Healthcare‘s Olive Branch Hospital for its dedication and excellence in treating heart attack patients. Methodist Olive Branch Hospital received the National Cardiovascular Data Registry Chest Pain – […]

Esperion Announces Submission of Supplemental New Drug Applications to U.S. FDA for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet

– 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 […]

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 […]