Suturion takes an important step towards a US launch

It is now official that Swedish medtech company Suturion has been accepted to the prestigious Safer Technologies Program (STeP) at the US Food and Drug Administration (FDA). An acceptance means a significantly faster approval process for medical devices that will increase patient safety and where there are no equivalent alternatives on the market.

Suturion is one of a few selected companies, a total of 23 globally, that have been admitted to the FDA’s STeP program with its innovative medical device Suture-TOOL. Admission to the program requires a medical device that the FDA considers to have particularly good potential to bring safety to the patient and has no equivalent alternatives on the market today.

– We are very honored to have been accepted to the STeP program. It means a lot that FDA sees the potential in Suture-TOOL and can provide both extra resources as well as a faster approval process, says Esteban Sanchez Marquez, RA/QA Manager at Suturion.

The purpose of the STeP program is to accelerate the process for FDA approval so that the medical tool can be launched as soon as possible.

– Suture-TOOL is truly one of a kind with great potential to increase patient safety after open abdominal surgery. We are looking forward to a more accelerated approval process, which will make it possible to launch sooner and by that reduce suffering for as many patients as possible, says Paan Hermansson, CEO at Suturion.

Suture-TOOL is a completely new medical tool designed to increase patient safety in open abdominal surgery, where around 1 in 3 patients* suffer painful suturing complications. The new technology allows the abdominal wall to be closed faster and with higher quality. Preliminary results from clinical studies show that the technology has potential to significantly reduce the risk of complications and increase patient safety.

*1. Deerenberg EB et al. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1254-1260. doi: 10.1016/S0140-6736(15)60459-7. Epub 2015 Jul 15. PMID: 26188742.
2. HART Collaborative. Incisional hernia following colorectal cancer surgery according to suture technique: Hughes Abdominal Repair Randomized Trial (HART). Br J Surg. 2022 Sep 9;109(10):943-950. doi: 10.1093/bjs/znac198. Erratum in: Br J Surg. 2022 Dec 13;110(1):126. PMID: 35979802; PMCID: PMC10364691.

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