PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart (TAH), aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces that the French National Authority for Health (HAS) has deemed the CARMAT TAH eligible with […]
Coronary/Structural Heart
Neovasc Achieves Design Freeze for Transfemoral Trans-septal Tiara™ Mitral Valve System
VANCOUVER and MINNEAPOLIS, Feb. 12, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE —Neovasc Inc.. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced today achievement of design […]
CARMELINA® subgroup analysis supports long-term cardiovascular and renal safety of linagliptin in older people with type 2 diabetes
Linagliptin did not increase the risk of adverse cardiovascular events, hospitalization for heart failure or adverse kidney events compared with placebo in older people with type 2 diabetes in a prespecified subgroup analysis of the CARMELINA® cardiovascular outcome trial1 In addition, linagliptin did not increase the risk of hypoglycemia compared with […]
Hoag Now Offers the Most Comprehensive Aortic Disease Center in Southern California
– Renowned Stanford University specialist joins Hoag to bring care for Marfan Syndrome and Related Conditions to the Jeffrey M. Carlton Heart & Vascular Institute – Hoag Presenting Sponsor of the Marfan Foundation Southern California Walk for Victory in February 2020 NEWPORT BEACH, Calif., Feb. 10, 2020 /PRNewswire/ — Hoag’s Jeffrey M. […]
Philips announces DEFINE GPS global multicenter study to assess outcomes of PCI procedures guided by integrated iFR and interventional X-ray images
Randomized controlled trial with up to 3,000 participants at 75 sites to compare outcomes between physiological guidance by iFR data co-registered on the angiogram (interventional X-ray image) versus the standard of care use of an angiogram alone Percutaneous coronary intervention (PCI) is one of the main treatment options to open […]
PhaseBio Announces European Regulatory Update for PB2452
PB2452 granted PRIME Designation by the European Medicines Agency PhaseBio receives written scientific advice confirming PB2452 clinical development plan In Phase 1 and Phase 2a clinical trials, PB2452 provided immediate and sustained reversal of the antiplatelet effects of ticagrelor MALVERN, Pa. and SAN DIEGO, Feb. 11, 2020 (GLOBE NEWSWIRE) — PhaseBio […]
CorMatrix® Cardiovascular, Inc. receives FDA approval to expand and enroll 20 additional patients in the adult arm of its early feasibility IDE study of the Cor® TRICUSPID ECM® valve for pediatric and adult patients
ATLANTA, Feb. 7, 2020 /PRNewswire/ — CorMatrix®Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced receiving FDA approval to expand and enroll 20 additional patients in the adult arm, including up to 4 additional cardiac surgery research and investigative centers, for its early feasibility IDE study of the Cor® TRICUSPID ECM® valve* for […]
Amarin Honored by BioNJ with Innovator Award for VASCEPA® Development and Regulatory Approval
DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 06, 2020 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), announced today that BioNJ awarded Amarin with an Innovator Award in recognition of the approval of a new indication for VASCEPA® (icosapent ethyl) by the U.S. Food and Drug Administration (FDA) in December 2019. This […]
BioVentrix Receives 2020 NUB Reimbursement Status 1 Renewal in Germany for the Revivent TC TransCatheter Ventricular Enhancement System
SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, today announced it received renewal of the highest priority reimbursement in Germany for the Revivent TC™ TransCatheter Ventricular Enhancement System by achieving the NUB Status 1 designation from InEk, the German […]
Paragonix Technologies, Inc., Announces First Successful Use of Paragonix SherpaPak™ Cardiac Transport System in Pediatric Transplant Recipients
Paragonix SherpaPak™ Cardiac Transport System is the only FDA-cleared and CE-marked device that safeguards hearts between donor and recipient patients CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced that the first series of pediatric donor hearts preserved and transported using Paragonix SherpaPak Cardiac Transport System occurred at University of Florida Health (UF […]



