Coronary/Structural Heart

Filterlex Medical Announces Positive Results from A First-In-Human Study for the CAPTIS® Full-Body Embolic Protection Device

Cardiovascular data presented at EuroPCR 2022 demonstrates successful device performance during a TAVR procedure with no complications.  CAESAREA, Israel, May 31, 2022 /PRNewswire/ — Filterlex Medical Ltd., a cardiovascular medical device startup, announced today results from a first-in-human (FIH) study demonstrating the safety, feasibility, and performance of the CAPTIS device. CAPTIS is […]

Mezzion Pharma Receives Clear FDA Path Forward for the Approval of Udenafil for Single Ventricle Heart Disease

SEOUL, South Korea and BETHESDA, Md. , May 31, 2022 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) met with the FDA Division of Cardiology and Nephrology (DCN) on Friday, May 27th to discuss with the FDA the path forward for the regulatory approval of udenafil for the treatment of single ventricle heart disease (SVHD) in […]

AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 2 DATA FOR INVESTIGATIONAL OLPASIRAN IN ADULTS WITH ELEVATED LIPOPROTEIN(a)

Study Showed Significant, Sustained Reduction in Lipoprotein(a) During Treatment Period Lipoprotein(a) Reduction was Consistent With Phase 1 Results  THOUSAND OAKS, Calif., May 31, 2022 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced positive topline data from the Phase 2 OCEAN(a)-DOSE clinical study, evaluating olpasiran (formerly AMG 890) in 281 adult patients with Lipoprotein(a), or […]

Toku Eyes, Developer of an AI Platform That Accurately Identifies Risk of Heart Attack Using an Eye Image, Expands to The US

With Toku Eyes’ artificial intelligence platform, the eye is not only the window to the soul — it is now a window to the state of your health AUCKLAND, New Zealand , May 31, 2022 /PRNewswire/ — Toku Eyes, the New Zealand-based developer of a multi-modal artificial intelligence platform for instant healthcare diagnostics, today announced […]

Lexicon Resubmits New Drug Application for Sotagliflozin for the Treatment of Heart Failure

THE WOODLANDS, Texas, May 31, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of sotagliflozin for the treatment of heart failure. The FDA has a […]

ŌNŌCOR Receives FDA Clearance for Novel Endovascular Retrieval Technology

The ŌNŌ is intended to simplify bailout procedures in the expanding world of structural heart disease interventions PHILADELPHIA, May 25, 2022 (GLOBE NEWSWIRE) — ŌNŌCOR LLC, a leader in endovascular safety technology, today announced it has received 510(k) U.S. Food and Drug Administration (FDA) clearance for its ŌNŌ retrieval system, […]

inHEART RECEIVES FDA CLEARANCE FOR NOVEL 3D CARDIAC MODELING SOLUTION

System creates 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize therapeutic interventions CAMBRIDGE, Mass. and BORDEAUX, France, May 24, 2022 /PRNewswire/ — inHEART, a privately-held medical device company delivering the world’s most sophisticated digital twin of the heart, announced today that it has received FDA 510(k) clearance […]

Caladrius Biosciences Provides Update on Phase 2b FREEDOM Trial of XOWNA® in Coronary Microvascular Dysfunction

Interim analysis to be conducted following enrollment suspension in the double-blind, randomized, placebo-controlled clinical trial Next development steps for XOWNA® to be announced by year-end 2022 following regulatory and business review Caladrius Management will host a conference call tomorrow, May 24th at 8:15 a.m. EDT BASKING RIDGE, N.J., May 23, 2022 (GLOBE […]

Alnylam Presents New Results from the ILLUMINATE-C Phase 3 Study of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1

– Lumasiran Demonstrated Evidence of Improvements in Exploratory Endpoints of Systemic Oxalosis, Including Echocardiographic Structure and Function, Nephrocalcinosis, and Kidney Stone Events – – Expands Upon Previously Reported Reductions in Plasma Oxalate in PH1 Patients with Severe Renal Impairment – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced new positive […]

V-Wave’s Ventura® Interatrial Shunt: One Year Follow-up from RELIEVE-HF Roll-in Arm Shows Improved Left and Right Ventricular Function in Patients with Advanced Heart Failure

Echo Core Laboratory Data Demonstrates the Potential of a 5-mm Diameter Shunt to Reduce Filling Volumes and Enhance Systolic Function of Both Ventricles, Consistent with Reverse Cardiac Remodeling MADRID, May 23, 2022 /PRNewswire/ — V-Wave Ltd, manufacturer of the V-Wave Ventura investigational interatrial shunt device to help patients with advanced heart failure (HF), […]