Author: Ken Dropiewski

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 […]

Mentice and Acandis GmbH announce a 3-year agreement for Mentice Ankyras clinical support software solutions at a value of 8.9mSEK

Sweden–Gothenburg and Germany-Pforzheim, October 25, 2022 (https://news.cision.com/mentice-ab). GOTHENBURG, Sweden, Oct. 25, 2022 /PRNewswire/ — Mentice AB (publ), Gothenburg, a world leader in simulation solutions for image-guided interventional therapies, announced today that Acandis, Pforzheim, a leading innovator of minimal invasive devices for the treatment of neurovascular diseases, has signed a 3-year collaboration agreement to further develop the Acandis […]

Philips highlights latest advances in stroke care at the 2022 World Stroke Congress

Source: Royal Philips (Philips Press Release) Philips showcases innovations in its end-to-end stroke care pathway solutions aimed at improving treatment and quality of life for stroke patients Symposium hosted by Philips features leading clinical experts discussing early detection of stroke, new guidelines for reperfusion therapy, and the health economic impact of […]

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 […]

HeartSciences Granted European Patent for Proprietary Electrode and Cable Connections for Use with its AI-Based MyoVista® ECG

Patent builds on previously granted U.S. patent as well as strengthens and diversifies the IP portfolio and further protects future revenues Southlake, Texas, Oct. 25, 2022 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), a medical technology company focused on saving lives by making […]

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 […]