Coronary/Structural Heart

Sequana Medical announces first-in-human data of Direct Sodium Removal (DSR) therapy published in Circulation

Positive pre-clinical and clinical proof-of-concept data of Sequana Medical’s innovative DSR therapy published in top tier peer-reviewed cardiovascular journal Data demonstrates potential for treatment of volume overload due to heart failure Ghent, BELGIUM – 10 January 2020 – Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid […]

Akcea and Ionis Announce Initiation of CARDIO-TTRansform Phase 3 Clinical Trial for AKCEA-TTR-LRx in Patients with TTR-mediated Amyloid Cardiomyopathy

BOSTON and CARLSBAD, Calif., Jan. 10, 2020 (GLOBE NEWSWIRE) — Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today the initiation of the CARDIO-TTRansform Phase 3 cardiovascular outcomes study for AKCEA-TTR-LRx in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR cardiomyopathy). “The […]

JenaValve Transcatheter Aortic Valve Replacement (TAVR) System Designated by FDA as Breakthrough Device

JenaValve Pericardial TAVR System is the First Transcatheter Device to Achieve Breakthrough Device Designation; Prioritizes Premarket Approval Development Path for Severe Aortic Regurgitation Indication IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, announced […]

FAST BioMedical Announces Successful Completion of Multi-center Acute Congestive Heart Failure Trial in Germany

INDIANAPOLIS and BERLIN and BAD NAUHEIM, Germany, Jan. 9, 2020 /PRNewswire/ — FAST BioMedical announced the completion of the EMPAKT-CHF clinical trial at Charité – Universitätsmedizin Berlin and Kerckhoff Klinik in Bad Nauheim.  The trial evaluated the impact of FAST BioMedical’s Blood Volume and Kidney Function measurement technology in patients with acute congestive heart failure and cardiorenal syndrome.  This […]

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 […]