Author: Ken Dropiewski

RA Medical’ DABRA Begins First Commercial, FDA-Cleared, In-Patient Use

NEW ORLEANS, La.–(BUSINESS WIRE)–Ra Medical Systems, makers of cardiovascular and dermatology catheters and excimer lasers, today announced the commercial launch in the United States of the Company’s groundbreaking DABRA™ System for the treatment of Peripheral Artery Disease. This follows FDA clearance earlier this week. Dr. Athar Ansari of the California […]

Somahlution Announces Patient Enrollment In Duragraft CABG European Registry

JUPITER, Fla., Jan. 4, 2017 /PRNewswire/ — Somahlution, a global biotechnology company developing products to reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications, today announced enrollment of the first subject in their DuraGraft CABG European Registry. The registry will evaluate the company’s flagship […]

First-in-Man study of novel sirolimus-coated balloon completes enrolment

PCRonline/News/Industry Press Releases Med Alliance has announced completion on schedule of patient enrolment in the First-in-Man (FIM) study of SELUTION™, a novel sirolimus-coated balloon.  50 patients have been enrolled between 26 October 2016 and 23 May 2017 across four German centres: Franziskus Krankenhaus, Berlin; Evangelisches Krankenhaus Hubertus, Berlin; Vivantes Klinikum […]

FDA Grants Market Clearance to RA Medical’s New PAD System

CARLSBAD, Calif.–(BUSINESS WIRE)–In an effort to battle Peripheral Artery Disease (PAD), the leading cause of limb amputations, the Food and Drug Administration (FDA) announced today that it has granted market clearance to Ra Medical Systems, makers of excimer lasers and catheters for cardiovascular and dermatological diseases, for the Company’s groundbreaking […]

Metastatic Colorectal Cancer Patients Treated First-line With SIR-Spheres® Y-90 Resin Microspheres More Likely to Become Candidates for Potentially Curative Liver Surgery, REsect Study Shows

NEWS PROVIDED BY Sirtex Medical Limited – 24 May, 2017, 03:09 ET MAINZ, Germany, May 24, 2017 /PRNewswire/ — Surgeons’ blinded assessment of pre- and post-treatment CT scans of patients with previously unresectable colorectal cancer liver metastases treated in the SIRFLOX study presented at 12th Annual European-African HPB meeting Adding selective […]

Medtronic Enrolls First Patient in Study of IN.PACT(TM) AV Access Drug-Coated Balloon in Patients with End-Stage Renal Disease

GlobalNewsWire DUBLIN – May 24, 2017 – Medtronic plc (NYSE: MDT) today announced that the first patient has been enrolled in the IN.PACT(TM) AV Access Drug-Coated Balloon (DCB) study for use in patients with end-stage renal disease (ESRD). The U.S. Food and Drug Administration (FDA) approved the investigational device exemption […]

InspireMD Announces Publication of the IRON-GUARD Registry in EuroIntervention

Press Release – InSpireMD BOSTON, MA—May 17, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the publication of the Investigator Initiated IRON-GUARD Italian clinical registry in the peer reviewed journal EuroIntervention, which […]

BioCardia Release: Study Shows Helix Transendocardial Delivery System Enables Greater Myocardial Retention Of Stem Cell Therapy

SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. (OTC:BCDA) today announced publication of a study in the International Heart Journal.1 According to the study, delivery of stem cell therapy to the heart using the Helix™transendocardial delivery system results in superior cell delivery than either percutaneous intra-coronary infusion or direct injection in an open […]