Coronary/Structural Heart

CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S. STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR™ Antithrombotic Removal System During Urgent Cardiothoracic Surgery

The U.S. STAR-D and already recruiting STAR-T randomized controlled pivotal trials are intended to establish DrugSorb-ATR as a single, easy-to-use solution for the reduction of perioperative bleeding in open heart surgery patients caused by the most widely prescribed next generation antiplatelet and anticoagulant drugs MONMOUTH JUNCTION, N.J., Oct. 12, 2021 /PRNewswire/ — CytoSorbents […]

Hyloris Acquires Breakthrough, Patented Technology to Develop and Market Aspirin IV in the U.S. in Acute Coronary Syndrome

Potential to revolutionise the current treatment paradigm and become the cornerstone therapy for patients with suspected acute coronary syndrome Enables accelerated development of HY-073 (IV acetylsalicylic acid), bringing the anticipated FDA submission date forward to end 2023 Initially targeting a total addressable patient population of ~2 million in the U.S. […]

BioCardia Issued New U.S. Patent for Technology that Enhances Control for Interventional Catheter Based Therapies

Technology Anticipated to Impact Cardiac Biologic Therapies, Transseptal Cardiac Procedures, and Other Interventional Catheter Based Therapies SAN CARLOS, Calif., Oct. 12, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the issuance of U.S. Patent […]

CARMAT Announces the Publication of an Article on the Aeson®’s Autoregulation System in the ASAIO Journal

Results from 10 patients enrolled in the PIVOTAL study show that autoregulation enables an appropriate and immediate adaptation of cardiac output to patients’ needs CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic […]

Hyloris Expands Cardiovascular Pipeline with Breakthrough Extended-Release Milrinone Capsule in Late-Stage Heart Failure

Patient-friendly alternative to continuous IV administration – proven safety and efficacy Targeting orphan, late-stage heart failure indication with high unmet medical needs Liège, Belgium – 8 October 2021 – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces […]

BioCardia Announces First Cross-Over Patient Treated in CardiAMP Cell Therapy Heart Failure Trial

SAN CARLOS, Calif., Oct. 07, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the treatment of the first cross-over patient in the ongoing Phase III Pivotal CardiAMP® Cell Therapy in Heart Failure Trial […]

PhaseBio Announces Interim Analysis of REVERSE-IT Phase 3 Trial Accepted for Late Breaking Science Presentation at the American Heart Association Scientific Sessions 2021

MALVERN, Pa. & SAN DIEGO–(BUSINESS WIRE)–PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial), the pivotal Phase 3 trial designed to study reversal of the antiplatelet effects of […]

ReCor Medical Launches the Paradise™ Ultrasound Renal Denervation for the Treatment of Hypertension in Europe

Treatment Supported by Evidence from Multiple Studies and Renal Denervation Position Paper from the European Society of Hypertension PALO ALTO, Calif. & FRANKFURT, Germany–(BUSINESS WIRE)–ReCor Medical, Inc. (“ReCor”), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., announced today that the company’s Paradise™ Ultrasound Renal Denervation System (the “Paradise™ […]

NeoChord Announces Successful Completion of First in Human Procedure with its NeoChord NeXuS Transcatheter Mitral Chordal Repair Technology

ST. LOUIS PARK, Minn., Oct. 04, 2021 (GLOBE NEWSWIRE) — NeoChord, Inc., a privately-held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation, today announced successful completion of the first-in-human procedure with the NeoChord NeXuS Transcatheter Mitral Chordal Repair technology (TMVr). […]

Annoviant Awarded $1.85M SBIR Phase II Grant from the National Institutes of Health

Funding will help drive commercialization of next-generation pulmonary valve conduit for pediatric patients ATLANTA–(BUSINESS WIRE)–Annoviant LLC, formerly TGen Tech LLC, today announced that it has been awarded a grant of $1.85 million for two years by the National Institutes of Health (NIH) to help further its development and commercialization of […]