Coronary/Structural Heart

Leqvio® Therapy to Lower Cholesterol Approved by FDA, IVX Health Now Accepting New Leqvio Patients

NASHVILLE, Tenn., Feb. 8, 2022 /PRNewswire/ — IVX Health, a national provider of infusion and injection therapy for patients with complex chronic conditions, announced today the expansion of its injection formulary with the addition of Leqvio® (inclisiran), a new FDA-approved therapy by Novartis Pharmaceuticals Corporation indicated for the treatment of adult patients with clinical atherosclerotic cardiovascular disease (ASCVD) […]

Neovasc Announces German Reimbursement Renewal and Commercial Progress

VANCOUVER and MINNEAPOLIS, Feb. 08, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (Neovasc or the Company) (NASDAQ, TSX: NVCN) today announced the German Institute for the Hospital Remuneration System (“InEK”) has awarded the Neovasc Reducer™ (“Reducer”), a CE-Marked medical device for the treatment of refractory angina, NUB Status 1 designation yet again for 2022.  […]

Abbott Announces World’s First Implant of Dual-Chamber Leadless Pacemaker in Pivotal Trial

– Abbott’s investigational Aveir™ DR dual-chamber pacemaker is designed to provide synchronous, beat-by-beat pacing of the right atrium and right ventricle of the heart – Proprietary implant-to-implant (i2i™) device technology is used for communication between two implanted leadless pacemakers to regulate the heart rate – Aveir DR is also specifically […]

Genesis MedTech Acquires JC Medical, Creates New Structural Heart Franchise

SINGAPORE, Feb. 4, 2022 /PRNewswire/ — Genesis MedTech Group (Genesis or Group) has completed the acquisition of JC Medical (JCM), a  structural heart company that is primarily engaged in the design and development of transcatheter valve replacement products for the minimally invasive treatment of structural heart diseases.  The acquisition means that Genesis […]

CroíValve Raises an €8M Series A Round to Support a Feasibility Clinical Study

DUBLIN–(BUSINESS WIRE)–CroíValve, a Dublin based medical device company developing a novel treatment for tricuspid regurgitation, has raised a Series A round to fund a Feasibility clinical study with its DUO Coaptation Valve system. This novel approach to treating tricuspid regurgitation combines the best of repair and replacement to provide the […]

Virtual Care Visits Demonstrate Effectiveness in Managing Hypertension in More Than 75 Percent of Patients During Pandemic

New Research From Included Health Finds Virtual Care With a Holistic Approach Controls Blood Pressure SAN FRANCISCO–(BUSINESS WIRE)–According to a new study published in Mayo Clinic Proceedings: Innovations, Quality & Outcomes, utilizing virtual care visits to manage hypertensive patients demonstrated an improvement in blood pressure in 77 percent of patients. According […]

Independent Publication Reports Neovasc Reducer™ Demonstrates Cost Savings

VANCOUVER and MINNEAPOLIS, Feb. 04, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (Neovasc or the Company) (NASDAQ, TSX: NVCN) today announced the publication of cost-effectiveness studies supporting the use of the Neovasc  Reducer™ (“Reducer”). The two analyses, authored by Americo Cicchetti, Graduate School of Health Economics and Management (ALTEMS) at the Catholic University […]

Cytokinetics Announces FDA Acceptance of New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure With Reduced Ejection Fraction

PDUFA Target Action Date Set for November 30, 2022 FDA is Currently Not Planning to Hold an Advisory Committee Meeting to Discuss the Application SOUTH SAN FRANCISCO, Calif., Feb. 04, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted and […]

BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

SUNNYVALE, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure. It is believed […]

AnaCardio exercises option to license a program in heart failure from Helsinn

AnaCardio exercises option to license a program in heart failure from Helsinn Lugano, Switzerland and Stockholm, Sweden, February 3, 2022 – Helsinn Group (“Helsinn”), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, and AnaCardio, a clinical stage biopharmaceutical company developing novel drugs to treat heart failure, are pleased to announce that AnaCardio has […]