Author: Ken Dropiewski

CHLA/USC Researchers Design Novel Micropacemaker

LOS ANGELES–(BUSINESS WIRE)–Investigators at Children’s Hospital Los Angeles and the University of Southern California have demonstrated the feasibility of implanting a micropacemaker system in the pericardial sac surrounding the heart — a breakthrough that may open up new cardiac pacing options for children and adults. The micropacemaker — inserted through a single, […]

Amarin Reports Last Patient Study Visit Has Occurred, an Important Step Towards Completion of REDUCE-IT™ Cardiovascular Outcomes Study

BEDMINSTER, N.J., and DUBLIN, Ireland, June 28, 2018 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced that the last patient study visit has occurred in its potential landmark cardiovascular outcomes study, REDUCE-IT™.  The company also reiterated […]

Endotronix Joins American Heart Association’s Center for Health Technology & Innovation to Broaden the Use of Guideline-Based Care for Heart Failure Patients

LISLE, Ill., June 28, 2018 /PRNewswire/ — Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure, today announced they have joined the American Heart Association’s Center for Health Technology & Innovation’s (CHTI) Innovators Network. The collaboration allows Endotronix to integrate the Association’s digital resources into the Cordella™ Heart […]

Edwards Comments On CMS Initiation Of National Coverage Analysis For TAVR

IRVINE, Calif., June 28, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today commented on the announcement by the U.S. Centers for Medicare and Medicaid Services (CMS) about a National Coverage Analysis (NCA) for transcatheter aortic valve replacement (TAVR): CMS […]

Endologix Reports Positive 1-Year Results from the Ovation® LUCY Study

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced 1-year results from the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) registry as reported on Saturday, June 23rd at the 2018 Society for Vascular Surgery Annual Meeting. The LUCY study […]

Embolx Announces FDA Clearance of Next Generation Sniper Balloon Occlusion Microcatheter to Deliver Pressure-Directed Therapy for Tumors, Enlarged Prostate and Fibroids

SUNNYVALE, Calif.–(BUSINESS WIRE)–Embolx, Inc., a medical device company developing microcatheters for arterial embolization procedures, today announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its next generation family of Sniper® Balloon Occlusion Microcatheters, an innovative system for pressure-directed arterial embolization therapy. […]

Lexington Biosciences Concludes Initial HeartSentry Clinical Study

VANCOUVER, British Columbia, June 27, 2018 (GLOBE NEWSWIRE) — Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce the completion of the initial HeartSentry study conducted at San Francisco Bay-area Diablo Clinical Research. “We are pleased with the performance of the […]

Beckman Coulter Diagnostics Receives U.S. FDA 510(k) Clearance for High- sensitivity Access hsTnI Assay

BREA, Calif., June 27, 2018 /PRNewswire/ — Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the entire Access family of immunoassay systems. The Access hsTnI assay […]