Tag: IDE
Xeltis receives IDE approval from US FDA for haemodialysis vascular access...
Xeltis has announced that it has gained approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) submission to...
CMS approves coverage for PQ Bypass TORUS 2 IDE trial
PQ Bypass announced today that it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the Investigational Device...
Lutonix BTK IDE: First Level 1 evidence of positive safety and...
Patrick Geraghty (St Louis, USA) presented new datapoints from the six-month outcomes of the Lutonix BTK IDE trial at the 2018 VEITHsymposium (13–17 November,...
Lutonix 014 DCB gathers first randomised evidence of positive safety and...
Six-month outcomes of the Lutonix BTK IDE trial, a multicentre randomised controlled trial using the Lutonix 014 drug-coated balloon (DCB; BD), has demonstrated that...
Two-year data from Viabahn BX IDE trial “promising”
The 24-month data from the Viabahn BX Flex balloon-expandable stent (Gore) investigational device exemption (IDE) trial are “promising” with sustained clinical and patency benefits...
Endologix announces enrolment of first patients in ELEVATE IDE clinical study
Endologix has announced today that the first patients were treated in the ELEVATE (Expanding patient applicability with polymer sealing Ovation Alto stent graft) investigational...
