Mediclose ®

The challenges of trocar-site fascia closure in laparoscopic surgery

Laparoscopic surgery, or minimally invasive surgery, involves small abdominal incisions for inserting a trocar and surgical devices. Despite its numerous advantages, effective trocar-site fascia closure remains challenging due to the small incisions and fascia elasticity, leading to extended surgery times and increased postoperative complications. Although laparoscopic surgery generally has lower wound infection rates than open surgery, infections still pose a substantial risk. This can potentially undermine the procedure's benefits and increase mortality. Obesity and common comorbidities like diabetes and hypertension further elevate the risks associated with inadequate fascia closure, underscoring the need for a solution.

Innovative features of the Mediclose System include:

Fully integrated system with preloaded needles and suture
Fully automatic closure, requiring only the press of a button
Needles oriented away from the internal organs, minimizing the risk of injury
Secure needle capture within the device, ensuring safe insertion, removal and disposal
Spreading mechanism that consistently positions the fascia in the needle pathway
No additional instruments required for fascial closure
Compatibility with 12mm trocars of four major commercial brands

These features results in the following advantages*:

Consistent closure
Procedural efficiency
Ease of use

*All claims made are supported by our first-in-human clinical investigation study. CCMO ID: NL67234.068.18

Mediclose in the Clinic:

First in Human study:

Completed in 2023
42 patients
Safe use in all patients
5x faster closure of the fascia with Mediclose than with manual suturing

Randomized controlled trial:

Planned for 2025

Mediclose Cartridge System: paving the way for sustainability

The second generation of the Mediclose System is currently under development, featuring a two-part design: the Mediclose Device and the Mediclose Cartridge, aimed at creating a semi-reusable Mediclose System. In laparoscopic surgery, multiple trocars are utilized, necessitating the closure of multiple incisions at the end of the surgery. Instead of discarding the entire Mediclose System after each use, only the small Mediclose Cartridge, which contains the needles and suture, will need to be disposed after each closure. The Mediclose Device itself can be reused for each trocar-site closure within the same patient. This innovation significantly reduces the costs per surgery and medical waste.

Future prospects:

Optimization for bariatric patients by enhancing the spreading mechanism
Further reduction of medical waste with a fully reusable design

In short, the Mediclose System offers significant potential for future advancements.

Mediclose ®

the fully integrated suturing solution

The Mediclose System is a sterile single-use device with integrated needles and absorbable suture, intended for use by healthcare professionals to close the abdominal fascia at a trocar-site following laparoscopic surgery. Unlike most existing systems that close the trocar-site incisions from the outside inwards, the Mediclose System closes the incisions inside outwards, keeping the needles’ points away from the internal organs.

In short, the Mediclose System offers significant potential for future advancements.

*All claims made are supported by our first-in-human clinical investigation study. CCMO ID: NL67234.068.18

ISO-certified

Quality on top

Quality is our top priority, which is why Corporis Medical is ISO 13485:2016 certified.

More information on the quality page.