Coronary/Structural Heart

LumiraDx Expands its Cardiovascular Testing Portfolio with CE Marking of its NT-proBNP Test and new Exclusion Claim for its D-Dimer Test

The LumiraDx NT-proBNP and the LumiraDx D-Dimer tests are currently the only quantitative direct fingerstick assays produced for each test. Run on the highly portable LumiraDx Platform, they are designed for near-patient testing with connected results in 12 minutes and 6 minutes, respectively The LumiraDx NT-proBNP test is a rapid microfluidic […]

Renovacor Announces Data from Pilot Pig Study Showing Successful Cardiac Transduction with REN-001 Delivered Via Low-Dose Retrograde Coronary Sinus Infusion Published in Journal of the American College of Cardiology: Basic to Translational Research

REN-001 delivered locally via low-dose retrograde coronary sinus infusion demonstrated robust, diffuse cardiomyocyte transduction in a large animal heart CAMBRIDGE, Mass.–(BUSINESS WIRE)–Renovacor, Inc. (NYSE: RCOR), a biotechnology company focused on delivering innovative precision therapies to improve the lives of patients and families battling genetically-driven cardiovascular and mechanistically-related diseases, today announced […]

GE Healthcare, Medtronic Partnership Accelerates Global Access to Personalized Care by Delivering Advanced Patient Monitoring Solutions on the CARESCAPE Platform

GE Healthcare, Medtronic receive FDA 510(k) clearance and CE Mark approval on the integration of advanced INVOS™ regional oximetry and Microstream™ capnography technologies on the CARESCAPE precision monitoring platform Helping providers improve patient outcomes and safety, Microstream™ capnography (CO2) technology captures evolving respiratory compromise while INVOS™ regional oximetry (rSO2) technology […]

Chiesi USA Announces First Analysis from the CAMEO Registry Assessing KENGREAL® (cangrelor) Use and Transition to Oral P2Y12 Inhibitors in Routine Clinical Practice

The CAMEO registry, an ongoing study to provide real-world data on KENGREAL® (cangrelor), has published interim results in the Journal of the American Heart Association. This analysis from CAMEO is the first analysis of its kind to describe acute medication administration in a percutaneous coronary intervention (PCI) setting with transition […]

Recardio and FDA Reach Agreement on Pivotal Phase 3 Trial Design

Recardio Inc., a late stage clinical-stage life science company developing regenerative therapies for cardiovascular diseases, announced that the FDA concurs with Recardio’s pivotal Heal-MI Phase 3 trial design with Dutogliptin in Acute Myocardial Infarction. SAN FRANCISCO, June 01, 2022 (GLOBE NEWSWIRE) — Recardio’s Phase 2 trial results demonstrated the excellent […]

CinCor Pharma Doses First Patient in Phase 2 FigHTN-CKD Trial Evaluating the Selective Aldosterone Synthase Inhibitor Baxdrostat (CIN-107) in Patients with Uncontrolled Hypertension and Chronic Kidney Disease

figHTN-CKD is CinCor’s fourth ongoing Phase 2 clinical trial evaluating baxdrostat (CIN-107) Initial topline data for figHTN-CKD expected in 2H 2023 WALTHAM, Mass., June 01, 2022 (GLOBE NEWSWIRE) — CinCor Pharma, Inc. (“CinCor”) announced today that the first patient has been dosed in the Phase 2 figHTN-CKD trial evaluating baxdrostat […]

DynamX Bioadaptor Restores Rotational Motion and Vessel Stress Reduction in New Study

Paper Published in Cardiovascular Revascularization Medicine Shows Innovative Coronary Artery Implant is Capable of Moving with Vessel, Unlike Conventional Stents MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced print publication of a study in the latest issue of Cardiovascular Revascularization Medicine that showed that the DynamX™ […]

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 […]