Mediclose™ is a sterile disposable device intended to pass a suture through the fascia of a 10-12 mm trocar induced wound, at the end of laparoscopic surgery.
Mediclose™ is a closure system that consists of the Mediclose™ Device, incorporating a needles-suture set, and the Mediclose™ Adaptor, to ensure compatibility with 12 mm trocars of selected trocar brands
Most existing systems close the trocar induced incisions from outside inwards, whereas the Mediclose™ System closes the incisions inside outward, with the position of the needles pointing away from any vital organs.
How does Mediclose™ work?
1. Insert via trocar
2. Press a button
3. Remove from trocar
Needles are pointed away from abdominal organs and are kept in safe-housing
Compatible with commonly used 12 mm trocar by connecting an adapter
Extremely fast closure, wounds can be closed within a minute
No cleaning and re-use, this avoiding contamination
First-in-Human trial for the Mediclose™ System - Currently ongoing
After pre-clinical validation of the Mediclose™ System, we moved onto our first patient studies in 2022. The goal of this first-in-man trial is to demonstrate clinical safety in humans. We will test the device on 40 patients that were already scheduled in for laparoscopic surgery and who have given their informed consent to be included.
This trial is performed in the Antoni van Leeuwenhoek hospital in Amsterdam, by our founder and CSO Dr. Alexander Veenhof and at the Maastricht University Medical Center by our advisory board member Nicole Bouvy.
The results of the safety trial will allow us to complete the CE documentation that is required for market authorization in the EU. Our CE technical file is already in an advanced state of review at our Notified body DEKRA and in preliminary review state with the FDA. Thus we expect to get CE mark and FDA approval in 2023.