Coronary/Structural Heart

FEops HEARTguide Authorized by FDA for Unprecedented LAAo Planning Capabilities

GENT, Belgium–(BUSINESS WIRE)–FEops today announced that it received De Novo authorization from the U.S. Food and Drug Administration (FDA) for FEops HEARTguide™ pre-operative planning of left atrial appendage occlusion with the Boston Scientific WATCHMAN™ device*. FEops HEARTguide™ will enable physicians to virtually model clinical scenarios with different implant positions and sizes […]

First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR™ Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., Oct. 14, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the first patient has been enrolled in the Safe and Timely Antithrombotic Removal-Ticagrelor (STAR–T) double-blind, randomized, controlled clinical trial designed to support […]

HeartFlow Announces Enrollment of First Two Patients in REVEALPLAQUE Trial

Trial to evaluate new technology that may help physicians prevent heart attacks in patients REDWOOD CITY, Calif., Oct. 14, 2021 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced the commencement of the REVEALPLAQUE (A pRospEctiVe, multicEnter study to AnaLyze PLAQUE using CCTA) trial to evaluate HeartFlow’s non-invasive plaque […]

PLx Pharma, Inc. Issues Statement on Recent USPTF Recommendations on Aspirin Therapy for Primary Prevention of Cardiovascular Disease; PLx’s VAZALORE Specifically Indicated for Secondary Prevention

Aspirin remains an established practice for the prevention of another heart attack or clot-related stroke SPARTA, N.J., Oct. 14, 2021 (GLOBE NEWSWIRE) — PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective […]

OpSens Successfully Treats First Patients in Human Clinical Study for TAVR Procedure

Quebec, Quebec, October 13, 2021 – OpSens Inc. (“OpSens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF), a cardiology medical device company providing innovative product solutions based on its patented optical technology, is pleased to announce the commencement of the human clinical study utilizing the SavvyWire, and successful treatment of the first patients. […]

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 […]