PQ Bypass touted 12-month data today from a trial evaluating its Detour percutaneous femoropopliteal bypass system. Results from the Detour I trial showed “promising 12-month durability” for patients with extremely long blockages in the superficial femoral artery, the company reported. The study included lesions that were longer and more complex than typically seen in SFA trials: […]
Tag: SFA
Medtronic IN.PACT(TM) Admiral(TM) Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions
DUBLIN – April 23, 2018 – Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360mm in patients with peripheral artery disease (PAD). Approval was based on clinical data from the […]
Cagent Vascular Presents Positive Results from the PRELUDE Study at LINC 2018
Feb. 7, 2018 14:30 UTC WAYNE, Pa.–(BUSINESS WIRE)– Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular interventions announces positive results from the First-in-Human PRELUDE Study. Dr. Andrew Holden (Auckland, New Zealand), Principal Investigator, presented 30-day and preliminary 6-month results using the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter at the Leipzig Interventional […]
Positive Twenty-Four Month Tack Optimized Balloon Angioplasty (“TOBA”) Single Center Results Presented at VEITHsymposium™ Conference
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally-invasive peripheral vascular procedures, today announced that positive single center twenty-four month results from its Tack Optimized Balloon Angioplasty (TOBA) clinical study were presented at the VEITHsymposium™ 2017 conference by Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany. The TOBA study enrolled 138 subjects at 13 sites […]
Cagent Vascular Completes Enrollment of PRELUDE Study Using Serranator Device
WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, including the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter, announces the completion of enrollment in the First-in-Human PRELUDE Study. The purpose of this prospective, single-arm, multicenter feasibility study is to show the safety and efficacy of […]