C. R. Bard Receives Fda Premarket Approval Of The Lutonix® 035 Drug Coated Balloon As The First And Only Dcb For The Treatment Of Patients With Dysfunctional Av Fistulae New Option to Preserve Vascular Access and Help Hemodialysis Patients Extend […]
Tag: DCB
QT Vascular begins enrollment in US pivotal study of its drug-coated peripheral balloon
SINGAPORE, July 31, 2017 /PRNewswire/ — QT Vascular Ltd., together with its subsidiaries (the “Company”), announced it has started enrollment in its United States (“US“) pivotal clinical study. The study will evaluate the Company’s drug coated balloon (“DCB“), the Chocolate Touch®, for use in […]
Spectranetics (SPNC) Secures FDA Approval of Stellarex Drug-Coated Balloon
COLORADO SPRINGS, Colo., July 26, 2017 (GLOBE NEWSWIRE) — The Spectranetics Corporation (NASDAQ:SPNC) today announced receipt of U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) of the Stellarex™ drug-coated balloon (DCB), designed to restore and maintain blood flow to the superficial […]
SurModics (SRDX) Receives IDE Approval To Initiate Pivotal Trial Of The Surveil Drug-Coated Balloon
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal […]
TriReme Medical Reports Negative Late Lumen Loss At 24-Month Angiographic Follow-Up For Chocolate Heart™ Drug-Coated Coronary Balloon
PLEASANTON, Calif., June 21, 2017 /PRNewswire/ — TriReme Medical LLC (the “Company”), a subsidiary of QT Vascular Ltd, announced today its angiographic data from 24-month follow-up of patients with De Novo lesions treated with Chocolate Heart™ as a standalone therapy. The initial […]
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 […]