104133VascuLok – A novel, safe and secure vessel ligating systemClosedCollaborative R&DInnovate UK"Clip devices are widely used in surgery where the occlusion/ligation of vessels is required. Mechanical ligation of the vessel using clip devices can offer major advantages including early ambulation and decreased hospital resource utilisation; however, they are also associated with incidences of bleeding through device failure and other more significant complications such as adhesion formation, erosion into surrounding structures and infection (minor complications in up to 7.2% of cases, major complications in up to 3%). Commonly used metal clips ('staples') have sharp, erosive ends and can cause tissue damage; their thin cross-sectional area promotes 'cheese-wiring' through vessels; the clips have no locking mechanism, are not secure and are easily dislodged. Current polymer-based clips have 'longitudinal' designs which still cause adhesion formation and problems with erosion into surrounding structures. Newtec Vascular Products seeks to advance their novel, patented, safe and secure vessel clip device 'VascuLok' suitable for use in surgery where vessel occlusion is required. VascuLok has a smooth 'rugby ball' profile shape with no 'edges', specifically designed to prevent adhesion formation/erosion in to nearby anatomical structures. VascuLok is manufactured from 'medical grade' polypropylene material (long history of safe use in man) which initiates an encapsulation response, further enhancing the locking mechanism by actively promoting the fibrous tissue capsule to form around the clip. The clip has a 'living' hinge, promoting a 'stand-off' from one clamp surface to another - giving an even clamp force over the entire clamp surface (provides security and prevents 'cheese-wiring' through clamped tissues), and a greater surface area for clamping. Its textured clamp surfaces allow better grip, and VascuLok clips are easy to remove if placed incorrectly. It causes no problems for subsequent MRI/CT scanning. This project will advance the technology from TRL5 to TRL7 through further development and prototype manufacturing, and demonstrate its clinical performance in a clinical study prior to regulatory certification and market launch initially into the vascular clip market from 2020\. Market need has been validated through extensive end-user consultation with Key Opinion Leading surgeons, and major interest shown. Strong transferability is envisaged in the cholecystectomy, male/female sterilisation markets and for neuro-surgery - targeted from 2022\. VascuLok will have a major impact =\> reducing serious complications during and after surgery, improving patient quality of life and reducing costs for the NHS. The project will deliver significant export led growth for Newtec, a substantial ROI, increased employment and further opportunity for R&D investment."