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 superficial femoral and popliteal arteries with the intention of obtaining […]
Peripheral/Endo
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 femoral and popliteal arteries in patients with peripheral arterial disease […]
Bolton Medical Announces the First Implant in the TREO® Global Registry
Sunrise, Fla, July 21, 2017 – Today announced the first implant of the TREO Abdominal Stent Graft System in the TREO Registry: a Post-Market Surveillance Clinical Investigation that aims to assess long term real-world data of the TREO Technology in a Global, Prospective, Multicenter and Observational Study. The technology that will […]
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 clinical trial of the SurVeil™ drug-coated balloon (DCB). The randomized […]
Angiolite BTK, below the knee sirolimus-eluting stent, changed CE Mark Approval
(BTK), improving blood flow in severe claudication and critical limb ischaemia. Angiolite BTK design has been specifically elaborated for drug eluting stent and benefits from iVascular proprietary coating nanotechnology that yields a multilayer thin coating with optimal kinetics. “Having the right bail-out options, when performing BTK angioplasty, is extremely important in […]
Silk Road Medical Announces $47 Million Financing Led By Norwest Venture Partners And Funds Managed By Janus Capital Management LLC
SUNNYVALE, Calif., July 18, 2017 /PRNewswire/ — Silk Road Medical, Inc., a company dedicated to alleviating the devastating burden of stroke through surgical innovation, today announced it has received $47 million in new funding led by new investors Norwest Venture Partners and funds managed by Janus Capital Management LLC. Existing investors Warburg Pincus, The Vertical Group, and […]
Intact Vascular Announces Enrollment Of First European Patient In Tack Optimized Balloon Angioplasty II Below The Knee (TOBA II BTK) Clinical Trial With The Tack Endovascular System
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial has commenced enrollment in Europe, with the first patient treated by Professor Dr. Marianne Brodmann and Dr. Peter Reif at Medical University Graz, Austria. […]
Gore Announces First-in-Human Use of GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System for TEVAR
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) today announced the first patient implant of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System after receiving CE Mark last month. The first implant was performed by Prof. Dr. med. Giovanni Torsello and Dr. med. Martin Austermann at […]
LimFlow Announces First Patient Treated In U.S. Feasibility Study And Commencement Of International Post-Market Study
PARIS–(BUSINESS WIRE)–LimFlow SA today announced enrollment of the first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System, a novel, purely percutaneous device for the treatment of end-stage critical limb ischemia (CLI) when all other revascularization efforts have been exhausted. The first patient was treated […]
Intact Vascular Release: FDA Approves 6-Month Primary Endpoint For The Tack Endovascular System In Below The Knee Disease
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial from 12 months to […]