Vascular Flow Technologies, the medical device company using proprietary Spiral Laminar Flow (SLF) technology to replicate natural blood flow for enhanced patient outcomes, has announced the launch of its Spiral Flow PV Bypass Graft registry at the 31st annual Deutschen Gesellschaft für Gefäßmedezin (DGG) in Münster.
The multicentre, observational, postmarket registry will collect longitudinal clinical performance outcomes of the Spiral Flow Peripheral Bypass Graft in patients undergoing femoro-popliteal bypass (for treatment of severe blockage due to plaque in the femoral artery). The study will be undertaken by GermanVasc, the German vascular society, and will observe the use of Spiral Flow Peripheral Bypass Graft in 100 patients with peripheral arterial occlusive disease during a 2 year period.
Professor Debus, Principal Investigator of the Spiral Flow PV Bypass Graft registry and Chair of the European Society of Vascular Surgery, commented: “With more than 450,000 patients being treated in Germany annually for vascular disease, it was important that comprehensive data is collected through a nationwide web-based recording of relevant vascular interventions to facilitate a greater understanding of the role of innovative technology on patient outcomes.”
The implantation of Vascular Flow Technologies’ Spiral Flow Graft was successfully demonstrated in a live case during the German Vascular/Endovascular Masterclass held in Hamburg on 9 October. The session specifically showcases new techniques and therapy methods for innovative medical technologies.
Bill Allan, CEO of Vascular Flow Technologies, commented: “The launch of the new Spiral Flow PV Bypass Graft registry in Germany is part of ongoing activities to provide long-term clinical evidence of Spiral Flow Graft performance when used in different clinical settings. This registry complements similar studies under way at more than 20 sites across the EU, the UK and the US.” Progress of the registry is now well under way, with 12 hospital sites already signed up.