Laminate Medical Technologies has announced the success of the first two German clinical cases using VasQ—an external support device for arteriovenous fistulas implanted during the fistula creation surgical procedure—following CE approval and 24 clinical cases completed at St George’s Hospital, London, UK.
The cases were performed by the team of Torsten Mildner, chief of Vascular Surgery, Endovascular Surgery and Phlebology at Harzklinikum Dorothea Erxleben, Wernigerode, Quedlinburg, Germany.
The VasQ targets the two main fistula failure modes: turbulent flow around the area of connection and increased venous wall tension due to the exposure to arterial circulation conditions. Disturbed fistula haemodynamics result in pathological thickening of the inner layer of the vein that leads to thrombosis and stenosis, a narrowing of the blood vessel.
“VasQ is very easy to use for an experienced arteriovenous fistula surgeon as there is no change on the standard procedure. As of VasQ´s conical design it is shaping the cephalic vein close to the anastomosis very nicely and post-surgery diagnostic such as duplex sonography showed typical arteriovenous fistula performance of blood flow in both the vein and the artery,” said Mildner. “The combination of the given angulation of VasQ and the fixation around the brachial artery is creating a positively standardised anastomosis area.” He added that therefore it could be conceivable that there is a beneficial impact on reduced intima hyperplasia as well as reduced stenosis rate in the cubital arteriovenous fistula area.
“VasQ showed tremendous promising results in the first-in-man clinical cases and these results will be proved by our multinational European and Israel Post-Market-Surveillance study which is planned to start in Q2 2016. The first two cases in Germany are a great milestone on our way to present our commitment and ability to innovate in the arteriovenous fistula space,” said chief executive officer Tammy Gilon. “We plan to launch VasQ in other major European markets very soon and file for Food and Drug Administration approval in 2017.”