Coronary/Structural Heart

Protembis Announces Completion of 20 Cases in European CE Mark Study With the ProtEmbo® Cerebral Protection System

Enrollment with advanced generation device for complete cerebral protection nearing halfway mark in clinical study in Germany and Poland AACHEN, Germany–(BUSINESS WIRE)–Protembis GmbH, a privately held emerging medical device company, announced today the successful completion of 20 clinical cases in its European regulatory study of the ProtEmbo® Cerebral Protection System. The […]

Occlutech announces Completion of Patient Enrolment in Pilot Study of Atrial Flow Regulator (AFR) in Patients with Heart Failure

SCHAFFHAUSEN, Switzerland, Feb. 24, 2021 /PRNewswire/ — Occlutech, a privately-held company, announced today the completion of patient enrolment in its pilot study to assess safety and efficacy of the novel Atrial Flow Regulator (AFR) in heart failure (HF) patients (PRELIEVE trial). PRELIEVE is a prospective, multicenter, open-label, non-randomized pilot study that evaluates the […]

Longeveron Announces Successful Completion of Phase 1 Clinical Study of Lomecel-B Intramyocardial Injection in Hypoplastic Left Heart Syndrome Patients

Intramyocardial injection of Lomecel-B well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B reported Full results of the Phase 1 clinical trial expected to be released in Q2 2021 Phase 2 trial expected to commence in Q3 2021 MIAMI, Feb. 24, 2021 (GLOBE NEWSWIRE) — […]

Abbott announces approval in Brazil to use two heart devices that can save the lives of babies and children

The world’s smallest pediatric treatments, developed by Abbott, meet the needs of the most vulnerable patients: babies and children born with congenital heart defects Approval includes use of a pediatric mechanical heart valve and the first minimally invasive device to treat premature and newborn babies with an opening in the […]

IMPULSE DYNAMICS RECEIVES APPROVAL TO SELL OPTIMIZER CCM DEVICES IN CHINA

NMPA Clears the Way for Impulse Dynamics to Deliver Hope for Heart Failure Population MARLTON, N.J., Feb. 22, 2021 (GLOBE NEWSWIRE) — Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced that the National Medical Products Administration (NMPA) approved the application for […]

Bracco Announces U.S. FDA Approval of 20-Vial Configuration of LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use

20-vial pack provides a green packaging alternative and helps increase storage efficiency MONROE TOWNSHIP, N.J., Feb. 22, 2021 /PRNewswire/ — Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world’s leading companies in the diagnostic imaging business, announced today that its ultrasound enhancing agent (UEA) LUMASON® (sulfur hexafluoride lipid-type […]

Tris Pharma and Athena Bioscience Announce Exclusive License Agreement to Commercialize Near-to-Market Long-Acting Antihypertensive Product in the U.S.

MONMOUTH JUNCTION, N.J. and ATHENS, Ga., Feb. 22, 2021 /PRNewswire/ — Tris Pharma, Inc. (“Tris”) and Athena Bioscience LLC (“Athena”) announced today that they have entered into an agreement by which Athena received exclusive rights to commercialize a long-acting antihypertensive product developed using  Tris’ proprietary technology. On average, only 50% of adults adhere to chronic […]

VALBIOTIS Announces the First Patient’s First Visit in the Phase II HEART Clinical Study on TOTUM-070 and Steps up Its Research Program Against Hypercholesterolemia in 2021

The first subject, with blood LDL-cholesterol (“bad cholesterol”) levels greater than 130 mg/dL, has undergone the initial medical examination for the HEART protocol on the active substance TOTUM-070. The HEART study will include 120 people with elevated blood LDL-cholesterol, a risk factor for cardiovascular disease and the primary endpoint of […]

Study Confirms Elucid’s AI Software Accurately Estimates Lesion-Specific Ischemia Compared to Standard of Care

BOSTON–(BUSINESS WIRE)–Elucid, a medical technology company developing AI software to enable cardiovascular disease detection, announced today the publication of new clinical data in the International Journal of Cardiology. The study, entitled “Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve” demonstrates that Fractional Flow Reserve (FFR) […]

Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System

DUBLIN, Feb. 17, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, has voluntarily issued a global recall of unused Medtronic Valiant Navion™ thoracic stent graft system and informed physicians to immediately cease use of the device until further notice. In accordance with its commitment to patient safety – […]