Author: Ken Dropiewski

TRANSFORM 1 Enrollment Completed: A Crucial RCT ready to redefine the DCB Angioplasty Mechanism

BIRMINGHAM, England, Sept. 13, 2022 /PRNewswire/ — Concept Medical announces the successful completion of the TRANSFORM 1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FOR MagicTouch Sirolimus Coated Balloon). The Randomized Controlled Trial (RCT) was conceptualized with the aim of understanding how the treatment indications and applications of Drug Coated Balloon (DCB) in coronary artery disease […]

Boston Heart Diagnostics Launches Polygenic Risk Scores Empowering the Next Generation of Clinical Genomics

FRAMINGHAM, Mass., Sept. 12, 2022 /PRNewswire/ — Boston Heart Diagnostics is pleased to announce the availability of the Polygenic Risk Map™. These genetic tests leverage Polygenic Risk Scores (PRS) to provide physicians with a much more precise understanding of their patient’s absolute genetic risk of complex disease, allowing for the creation of early, personalized intervention […]

Prolifagen Therapeutics Appoints M. Alexander Shaw, PhD, as Chief Executive Officer

VILLANOVA, Pa., Sept. 13, 2022 /PRNewswire/ — Prolifagen Therapeutics, a biotech startup developing medicines for cardiac regeneration, has appointed M. Alexander Shaw, PhD, as Chief Executive Officer. In this role, Dr. Shaw will lead Prolifagen’s efforts in bringing new medicines to market to prevent development of heart failure in patients with large myocardial […]

Overland Park Regional Medical Center Extends Leadership in Robotic Treatment of Heart Rhythm Disorders with Plans for Second Stereotaxis System

ST. LOUIS, Sept. 13, 2022 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that Overland Park Regional Medical Center (OPRMC) is establishing its second robotic program for the treatment of heart rhythm disorders. OPRMC, a part of HCA Midwest […]

HeartSciences Provides Business Update and Reports First Quarter Fiscal 2023 Financial Results

Nearing Completion of Patient Recruitment in FDA Pivotal Clinical Validation Study of MyoVista® Remains on Track for MyoVista® FDA De Novo Resubmission in Current Fiscal Year Southlake, Texas, Sept. 13, 2022 (GLOBE NEWSWIRE) —  Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), a medical technology company […]

THE SAGE GROUP Comments on National Peripheral Artery Disease (PAD) Awareness Month

BEAUFORT, S.C.–(BUSINESS WIRE)–According to THE SAGE GROUP, 21 million Americans suffer from PAD representing an economic burden of $283-$539 billion. “Twenty years ago we wrote that PAD was underestimated, underdiagnosed and undertreated,” stated Mary L. Yost, President. “Unfortunately, this is still true.” Reflecting on the current state of PAD and […]

TCT 2022: Impella Enables Complete Revascularization, Improved Quality of Life and Native Heart Recovery

BOSTON–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) will highlight how Impella heart pumps help heart teams achieve more complete high-risk revascularization and heart recovery in the catheterization lab and operating room at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 Conference, held in Boston from September 16 to 19. During the conference, physician-researchers will present clinical data […]

ABK Biomedical announces FDA 510(k) clearance of Easi-Vue™ embolic microspheres for the embolization of arteriovenous malformations and hypervascular tumors

HALIFAX, Nova Scotia, Sept 12, 2022 – ABK Biomedical, Inc., an innovative medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces FDA 510(k) clearance of Easi-Vue embolic microspheres for the treatment of patients suffering from arteriovenous malformations and hypervascular tumors. Arteriovenous malformations (AVMs) […]

EDWARDS LAUNCHES SAPIEN 3 ULTRA RESILIA VALVE FOLLOWING FDA APPROVAL

IRVINE, Calif., Sept. 12, 2022 /PRNewswire/ — Edwards Lifesciences ( NYSE: EW) today announced the launch of the SAPIEN 3 Ultra RESILIA valve, which incorporates Edwards’ breakthrough RESILIA tissue technology with the industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve. The launch follows recent U.S. Food and Drug Administration (FDA) approval. RESILIA tissue is […]

Merit Medical Launches the Prelude Roadster™ Guide Sheath

New long guide sheath accesses difficult anatomy in the peripheral vasculature, expanding treatment to more patients SOUTH JORDAN, Utah, Sept. 12, 2022 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced U.S. commercial release of the Prelude Roadster™ Guide […]