Coronary/Structural Heart

FDA Confirms Non-Exempt Status of Medical Device but No Plans to Inform the Patients as Confirmed by Dr. Rajamannan in Press Conference at Most Sacred Heart of Jesus Cardiology and Valvular Institute

FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens. SHEBOYGAN, Wis., Jan. 9, 2020 /PRNewswire/ — Following recent reporting by Kaiser Health News that the FDA has lifted their exemption laws, Dr. Nalini Rajamannan a specialist for patients with valvular heart disease in Most Sacred Heart of Jesus Cardiology, […]

CHF Solutions Announces Presentation of Clinical Data with Aquadex FlexFlow® Highlighting Efficacy and Simplicity of Use In Treating Critical Care Patients

EDEN PRAIRIE, Minn., Jan. 08, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced results from an investigator-initiated retrospective analysis of utilization of the Aquadex FlexFlow aquapheresis system at Lenox Hill Hospital in New York City. The study was presented at the American Society of Nephrology’s Kidney Week in […]

BioCardia Announces New U.S. Patent Covering CardiAMP Cell Therapy and Issuance of Two Asian Patents Covering Radial Artery Approach for Cardiac Cell and Gene Therapy Delivery

SAN CARLOS, Calif., Jan. 08, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of three new patents for the company’s technologies in the U.S., China and Japan. The new U.S. patent relates to the cell potency […]

Sequana Medical announces first patient enrolled in RED DESERT – REpeated Dose alfapump® DSR study for Treatment of diuretic-resistant heart failure patients

The study aims to: Evaluate the safety of alfapump DSR in patients with heart failure Assess the feasibility of alfapump DSR to remove excess sodium and fluid from the body Explore the potential impact of DSR therapy to restore response to diuretics GHENT, Belgium, Jan. 07, 2020 (GLOBE NEWSWIRE) — Sequana Medical NV […]

Cytokinetics Announces Start of Redwood-HCM, a Phase 2 Clinical Trial of CK-3773274

Next-Generation Cardiac Myosin Inhibitor Advances In Clinical Trial Designed to Assess Effects Using Two-Week Dose Titration Schedule SOUTH SAN FRANCISCO, Calif., Jan. 06, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) has opened to enrollment. REDWOOD-HCM is a Phase 2 clinical […]

VASCEPA® Approved in Canada to Reduce the Risk of Cardiovascular Events

VASCEPA becomes the first and only Health Canada approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in the studied high-risk patients approved for treatment Commercial launch expected in mid-February 2020 by Amarin’s commercial partner for Canada VASCEPA approval was supported by clinical results from the REDUCE-IT® trial which included […]

Neovasc Submits Premarket Approval Application to FDA for Neovasc Reducer™

VANCOUVER, Dec. 31, 2019 (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, today announced the submission of a Premarket […]

CryoLife Receives FDA Authorization to Commence PROACT Xa Clinical Trial

Study Designed to Evaluate the Use of Apixaban in On-X Aortic Valve Patients ATLANTA, Dec. 23, 2019 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has received authorization from the U.S. Food and Drug Administration (FDA) pursuant to an Investigational New […]

Acasti Pharma Provides Update on Timing of Topline Results for TRILOGY 1 Phase 3 Trial of CaPre

Expects to report Trilogy 1 topline results in January 2020 with topline results for Trilogy 2 still expected by the end of January 2020 LAVAL, Québec, Dec. 23, 2019 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the […]

Quantum Genomics Initiates its Pivotal Phase III FRESH Trial in Difficult-to-Treat and Resistant Hypertension

PARIS and NEW YORK, Dec. 19, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC, OTCQX – QNNTF), a biopharmaceutical company specializing in developing a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today announced the initiation of its pivotal Phase III FRESH study […]