Coronary/Structural Heart

Sequana Medical announces positive top-line results from the North American pivotal alfapump® study (POSEIDON)

alfapump achieves pre-specified primary effectiveness endpoints with statistical significance at six months post-implantation: o 100% median per-patient reduction in therapeutic paracentesis (TP) post- vs preimplantation (p<0.001) o 77% of patients with at least 50% reduction in number of TP post- vs pre-implantation (p<0.001) alfapump primary safety endpoint data in line […]

MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval

GENEVA, Oct. 25, 2022 /PRNewswire/ — Following our communication last  week “MedAlliance to be acquired by Cordis”, MedAlliance is pleased to make the following announcement: SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal clinical trial.  This is the first sustained limus release coronary […]

Applied Therapeutics Announces Full Enrollment in the Registrational Phase 3 ARISE-HF Trial of AT-001 in Diabetic Cardiomyopathy

ARISE-HF is a global registrational study in 675 patients with Diabetic Cardiomyopathy (DbCM), evaluating the potential of AT-001 to improve or prevent worsening of cardiac function vs. placebo Primary study endpoint is cardiac functional capacity (measured by Peak VO2) at 15 months DbCM is a form of heart failure affecting […]

Windtree Announces Notice of Allowance from the US Patent and Trademark Office for a New Istaroxime Patent

Anticipated New Patent Will Add to the Istaroxime Patent Estate and Provide Intellectual Property Protection Until Late 2039 WARRINGTON, Pa., Oct. 25, 2022 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular disorders, today reported that the United States Patent […]

CorVista Health Receives Breakthrough Device Designation for The CorVista® System

WASHINGTON–(BUSINESS WIRE)–CorVista Health, Inc, a digital health company dedicated to improving cardiovascular disease diagnosis, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CorVista System as a first non-invasive point of care diagnostic solution for patients with suspected pulmonary hypertension. The FDA’s Breakthrough […]

CARMAT Announces That It Has Received the Necessary Regulatory Approvals to Resume Aeson® Commercial Implants

DEKRA has provided notified body approval of all changes implemented by CARMAT PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR), the designer and developer of Aeson®, the world’s most advanced total artificial heart, designed to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announced today that it has […]

V-Wave Completes Enrollment in the RELIEVE-HF Randomized Double-Blind Controlled Trial of Interatrial Shunting for Heart Failure

The RELIEVE-HF trial of the Ventura® Shunt System includes patients with reduced and preserved left ventricular function etiologies for heart failure CAESAREA, Israel, Oct. 24, 2022 /PRNewswire/ — V-Wave, announced today the completion of enrollment in RELIEVE-HF, a prospective, randomized, double-blinded, sham-controlled, multi-center pivotal clinical trial.  The RELIEVE-HF study is assessing the safety […]

Cohere Health and Humana Expand Partnership to Further Improve Physician and Member Experiences

Technology will bundle and accelerate prior authorization for cardiovascular and surgical services BOSTON, Oct. 24, 2022 /PRNewswire/ — Today Cohere Health, a leader in intelligent utilization management (UM) technology, announced that Humana Inc. (NYSE: HUM) will expand its use of Cohere’s digital UM collaboration platform to enable seamless prior authorization for cardiovascular and surgical services. […]

Englewood Health Achieves Highest Possible Quality Rating for Valve Replacement Procedure

New Jersey’s only hospital to achieve a 3-star rating for transcatheter aortic valve replacement ENGLEWOOD, N.J., Oct. 24, 2022 /PRNewswire/ — Englewood Health has been recognized by The Society of Thoracic Surgeons with a 3-star rating—the highest possible quality rating—for transcatheter aortic valve replacement (TAVR). This mark of distinction reflects the accomplishments of the […]

BioSig Signs Master Research Agreement with Cleveland Clinic to Explore Expanded Applications for its Digital Signal Processing Technology

Medical Center of Excellence to leverage the Company’s PURE EP™ System to further its research and educational objectives as a leader in cardiac electrophysiology Clinical investigations conducted by Cleveland Clinic could expand clinical parameters of BioSig’s digital signal processing technology for arrhythmia care   BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or […]