Surgeon Gabriel Börner often encountered complications with the closure of the abdomen after surgery that resulted in wound infections and incisional hernias. With the aim of preventing hernias, rather than repairing them, Dr Börner saw a need for a surgical device that aids surgeons.
Why the technology is needed
Closure of the abdomen is the most hazardous surgical moment for staff and surgeons to get sharp injuries. These injuries imposes a risk of acquiring blood-borne diseases such as HIV or hepatitis. The Suture-Tool reduces this risk by keeping the suture needle away from users’ hands.
Suture-Tool offers a unique technical solution in surgical suturing. It closes the incision after abdominal surgery faster and with higher precision compared to traditional manual techniques, which reduce operating times and complications such as wound infections and incisional hernia.
Entering clinical trials
The first pre-clinical study was a proof-of-concept with 10 surgeons making manual needle driver incision closures and Suture-Tool lines in a model. Results showed 30 per cent faster stitching with the Suture-Tool and 95 per cent adherence to acceptable quality compared to 30 per cent with manual technique. Extensive pre-clinical research has demonstrated proof of concept and Suturion is now very close to entering into clinical trials.
A safety – efficacy study is planned to start after summer where the sewing machine will be used in a clinical setting to gather data for CE mark application later in 2023.
Establishing a new golden standard
As of April 2022, Suturion is one of the very few selected companies chosen for the MedLim start-up program. The program accelerates start-ups that want to bring a new medical device and/or technology to the global market. MedLim provides unique and profound experience and knowledge to help startups increase the pace for quicker commercialisation, as well as giving participating companies an access to a network of potential partners.
“Suturion is determined to challenge the current practice in abdominal wall closure by establishing a new golden standard for the most efficient and effective fascia closure, to save time, cost and unnecessary patient complications”, says CEO Paan Hermansson.