Author: Ken Dropiewski

HeartStitch® GmbH Announces NobleStitch™ EL Closure Data Compared to Published PFO Clinical Trials “RESPECT” and “CLOSURE” in New England Journal of Medicine

FRANKFURT, Germany, Oct. 6, 2017 /PRNewswire/ — Prof. Dr. Achille Gaspardone, Director of Cardiology at Hospital of Sant’Eugenio (Rome, Italy) presented a comprehensive report on closure of PFO (Patent Foramen Ovale) utilizing the NobleStitch™ EL suture based closure system at the CSI-UCSF meeting on Congenital Structural Interventions in San Francisco.  The NobleStitch™ EL, […]

BIOTRONIK Announces First Enrollments to BIOVITESSE Trial

(PresseBox) – BIOTRONIK has announced the start of enrollment of a coronary stent trial aiming at assessing the safety and clinical performance of a new coronary stent in de novo coronary artery lesions. On September 28, first Dr. Marco Moccetti, Cardiocentro Ticino, Lugano, Switzerland, and later on the same day Dr. Lorenz Raeber, University […]

Bay Area’s Shockwave Medical Lands $35 Million

October 10, 2017 07:00 AM Eastern Daylight Time FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today reported $35 million in new financing, an extension of the company’s previously announced $45 million Series C financing. New investor Fidelity Management & Research Company participated, along with […]

First Patient Treated With Microscopic Beads Pre-loaded With a Targeted Cancer Drug and Visible on CT Scans

LONDON, October 9, 2017 /PRNewswire/ — Researchers from the UCL Cancer Institute and the specialist healthcare company BTG plc (LSE: BTG) have begun the first clinical trial of an experimental treatment for liver cancer using X-ray imageable microscopic beads loaded with a targeted anti-cancer drug placed directly in the liver. The trial […]

Essential Medical Release: The MANTA Large Bore Vascular Closure Device To Be Evaluated In A 500-Patient European Post Market Clinical Registry

EXTON, Pennsylvania, Oct. 9, 2017 /PRNewswire/ –Essential Medical, Inc. today announced initiation of enrollment in a post market clinical registry in the regions where MANTA is commercially available. Principle Investigator Nicolas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology at Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands stated, “MANTA has quickly become […]

Medtronic (MDT)’s Stent System Wins FDA OK to Treat Short Neck Anatomies When Used With Heli-FX EndoAnchor System

DUBLIN – October 9, 2017 – Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the Endurant(TM) II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60° infra-renal angulation when used in combination […]

Endologix Receives IDE Approval For The EVAS2 Confirmatory Clinical Study To Evaluate The Nellix Endovascular Aneurysm Sealing System

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption (“IDE”) approval from the United States Food and Drug Administration (“FDA”) to commence a confirmatory clinical study to evaluate the safety and effectiveness of the Nellix […]

FDA Grants Marketing Clearance for the Peerbridge Cor™ Multi-channel Remote ECG Monitor

NEW YORK, Oct. 4, 2017 /PRNewswire/ — Peerbridge Health Inc., a Health IT company, announced today that its first product, the Peerbridge Cor™ System — a wireless electrocardiogram (ECG) monitor — has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The patented Peerbridge Cor has the smallest on-body footprint of any […]