Coronary/Structural Heart

CinCor Pharma Announces Publication of Phase 1 Multiple Ascending Dose Study Data in Hypertension Research

WALTHAM, Mass., Oct. 21, 2022 (GLOBE NEWSWIRE) — CinCor Pharma, Inc. (NASDAQ: CINC) today announced the publication of Phase 1 clinical data for baxdrostat, a highly selective, once daily, oral small molecule inhibitor of aldosterone synthase, in the journal Hypertension Research. The publication includes clinical data from the company’s randomized, Phase […]

U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for CAMZYOS® (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy to Reduce the Need for Septal Reduction Therapy

U.S. FDA has assigned a target action date of June 16, 2023 Application based on results from the Phase 3 VALOR-HCM study PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for CAMZYOS® (mavacamten) for an […]

Abiomed Successfully Completes All Impella Post-Approval Studies for High-Risk PCI, Cardiogenic Shock, Post-Cardiotomy Cardiogenic Shock and Right Heart Failure

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces the U.S. Food and Drug Administration (FDA) has accepted and closed the post-approval study reports related to the pre-market approvals (PMA) for Impella heart pumps. The FDA’s action is another affirmation that Impella heart pumps are safe and effective for cardiogenic shock, high-risk PCI, post-cardiotomy cardiogenic […]

NeoChord Announces Positive 1-year Follow-Up Data with Transcatheter NeXuS System for Mitral Chordal Repair Using Multiple Chords to a Single Anchor

ST. LOUIS PARK, Minn., Oct. 19, 2022 (GLOBE NEWSWIRE) — NeoChord, Inc., a privately-held medical technology company, is leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation with more than a decade of commercial experience in treating over 1,800 patients globally with the transapical […]

Vivasc Therapeutics Inc. Receives Its Second NIH Phase I STTR Grant With the Goal of Reversing the Molecular Causes of Heart Failure

This approach may be a paradigm shift in patient care PITTSBURGH–(BUSINESS WIRE)–Vivasc Therapeutics Inc. is pleased to announce it has initiated its second NIH Phase I STTR research grant (Award Number R41HL164212), in conjunction with Georgetown University. This work is supported by the NIH National Heart, Lung, and Blood Institute, […]

GE Healthcare and AMC Health to Partner in Remote Patient Monitoring to Provide Patients with Chronic and Post-Acute Care in the Home

CHICAGO & NEW YORK–(BUSINESS WIRE)–GE Healthcare and AMC Health today announced a collaboration that allows clinicians to offer Remote Patient Monitoring (RPM) as a virtual care solution that extends patient care outside the hospital to the home environment. The combination of GE Healthcare’s acute patient monitoring capabilities in the hospital […]

Cordis Announces Acquisition of MedAlliance, Positioning Itself for Market Leadership in Drug-Eluting Balloon Technology

MIAMI LAKES, Fla., Oct. 18, 2022 /PRNewswire/ — Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technologies, today announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance, a Switzerland-based company at the forefront of transformative drug-eluting balloons. By acquiring MedAlliance, Cordis has the potential to […]

HeartFlow Receives FDA 510(k) Clearance for its Plaque Analysis and RoadMap™ Analysis

HeartFlow is the first and only company to provide non-invasive anatomy, physiology, and plaque information based on coronary computed tomography angiography (CCTA) MOUNTAIN VIEW, Calif., Oct. 18, 2022 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, has received U.S. Food and Drug Administration (FDA) 510(k) clearance on […]

Revamp Medical Announces First Patient Enrolled in Early Feasibility Study, Evaluating Doraya Catheter for Relieving Congestion in Acute Heart Failure (AHF) Patients

Cardiologists at The Christ Hospital in Cincinnati, Ohio, are first in the US to begin testing Doraya as part of an EFS for AHF patients with insufficient response to diuretics NETANYA, Israel, Oct. 18, 2022 /PRNewswire/ — Revamp Medical, a pioneering developer of a percutaneous device for the treatment of acute heart failure (AHF), today announced the enrollment of the […]

Aerovate Therapeutics Presents Novel Phase 2b/Phase 3 IMPAHCT Trial Design at CHEST Annual Meeting 2022

Adaptive and efficient trial design may allow for expedited development timeline while maintaining scientific rigor WALTHAM, Mass., Oct. 18, 2022 (GLOBE NEWSWIRE) — Aerovate Therapeutics, Inc. (Nasdaq: AVTE) today presents the design of IMPAHCT (Inhaled iMatinib for Pulmonary Arterial Hypertension Clinical Trial; AV-101-002), a Phase 2b/Phase 3 trial investigating the […]