TrackCath System™, the novel Medyria Blood Flow Velocity Sensor equipped catheter was carried out safely and exhibited the intended benefits during a First in Human EVAR procedure performed on 20 March 2018 in UniKlinik RWTH, Aachen by PD. Dr. Johannes Kalder, Vascular Surgeon and Deputy Chief of the Department of Vascular Surgery, University Hospital; RWTH Aachen, Germany
PD. Dr. Johannes Kalder said “TrackCath System™ was used for the identification of coeliac trunk, superior mesenteric artery and right renal artery. The TrackCath System™ Blood Flow Velocity Measurement worked smoothly and allowed quick and easy identification of the three vessels. Cannulation was performed in the superior mesenteric artery using the TrackCath System™ catheter.
TrackCath System™ provides exceptional support during wire exchange. I have been involved in the early stage development and animal studies of TrackCath System™ with Dr. Mauro Sette, founder and Chief Technology Officer of Medyria. I always believed in the TrackCath System technology, as it is designed to answer a clear unmet need. I am now very pleased to be associated with the clinical development of TrackCath System™
Gilles Lachkar, CEO of Medyria, said “This is a major milestone for both Medyria and for the advancement of effective identification and cannulation of side branches during EVAR procedures. Medyria is developing the TrackCath System™ to bring accuracy and speed during the cannulation phase of complex EVAR procedures. This successful first clinical result confirms the promise of the TrackCath System™ in improving the management of complex EVAR and reducing utilisation of X-rays and Contrast dye during the procedure”
Medyria First in Human trial (Access Trial) is a prospective, single-arm, multicentre clinical trial performed on 32 patients treated with standard or complex EVAR procedures.
Access trial is a necessary step towards CE-Mark and is geared to be completed by summer 2018 according to initial plan.
The objective of the study is to assess the safety and performance of the TrackCath System™ to establish clinical evidence. Secondary objectives encompass additional scientific data such as procedure duration, C-dye consumption and X-ray exposure.
Investigational sites are:
Universitätsklinikum Düsseldorf - Klinik für Gefäß- und Endovaskularchirurgie:
Prof. Dr. med. Hubert Schelzig (Country Coordinator)
Universitätsklinikum Aachen – Klinik für Gefäßchirugie:
Priv.-Doz. Dr. med. Johannes Kalder
Universitätsklinikum Hamburg – Universitäres Herzzentrum Hamburg GmbH (UHZ) – Klinik und Poliklinik für Gefäßmedizin:
Prof. Dr. med. Tilo Kölbel
Universitätsklinikum Leipzig – Klinik und Poliklinik für Angiologie:
Priv.-Doz. Dr. med. Andrej Schmidt