Image source: Tissium
News • Medical technology
Hernia care: CE mark for non-penetrating mesh fixation
Second regulatory approval further validates Tissium's polymer platform across distinct surgical applications and geographies
Tissium, a clinical and commercial stage MedTech company that develops biomorphic programmable polymers for atraumatic tissue reconstruction, has received CE marking for Eclipsium, its solution for atraumatic mesh fixation in ventral hernia repair. The marking covers the non-penetrating fixation of composite meshes to soft tissue in ventral hernia repair performed through a minimally invasive intraperitoneal approach. It paves the way for commercialization in Europe.
Eclipsium follows the U.S. Food and Drug Administration (FDA) De Novo marketing authorization of Coaptium Connect for peripheral nerve repair in 2025. Coaptium Connect established the regulatory foundation for Tissium's first polymer-based product. The CE marking of Eclipsium further demonstrates the versatility of the company's technology.
Image source: Tissium
The two products target very different procedures, from microsurgical nerve repair to abdominal wall surgery, and hold authorizations in the United States and the EU, respectively. Christophe Bancel, Co-Founder and CEO of Tissium, said: "With Coaptium Connect, we proved our technology in microsurgery, for Atraumatic repair of nerves at the scale of few millimeters in open surgery, with our first authorization in the United States. With Eclipsium, we are now addressing atraumatic fixation of large implants of 15 to 20 centimeters in minimally invasive general surgery, with approval in Europe. Two products, at opposite ends of the surgical spectrum, built from the same polymer technology: that is the power of a true innovation platform."
Eclipsium is designed to enable non-penetrating fixation of a surgical mesh to soft tissue during minimally invasive hernia repair. It combines Tissium's proprietary bioabsorbable, light-activated polymer with dedicated accessories. By avoiding tissue penetration associated with conventional fixation devices such as tacks or sutures, Eclipsium is designed to be atraumatic, while giving surgeons control over mesh positioning and on-demand fixation.
The CE marking follows the completion of enrollment in Tissium's European ALPHA clinical study. The study evaluated the safety and performance of Eclipsium in patients undergoing laparoscopic ventral hernia repair. It was conducted at multiple clinical centers in Belgium and Spain and formed part of the clinical evidence supporting the regulatory submission.
For decades, sutures, staples and tacks have been the default, often at the cost of additional trauma. [...] Our ambition is to make atraumatic tissue reconstruction the new standard across surgery
Maria Pereira
Dr. Tim Tollens, General Surgeon at Imelda Hospital in Bonheiden, Belgium, said: "When we treated the first patient in the ALPHA study, our goal was to find an alternative to the invasive tacks and sutures that are a frequent source of pain after minimally invasive laparoscopic ventral hernia repair. Throughout the study, I have appreciated the control Eclipsium gives over mesh positioning, the simplicity of its on-demand fixation, and the potential this technology has to improve patient outcomes and quality of life. For the first time, we were treating our patients via daycare instead of being hospitalized for 1 or 2 days. The CE marking is an important step toward making this atraumatic approach available to surgeons and patients across Europe."
Dr. Salvador Morales-Conde, Head of the Department of Surgery at Virgen Macarena University Hospital, said: "As laparoscopic and robotic abdominal wall surgery continues to grow, surgeons need fixation solutions that are both secure and respectful of the tissue. Our experience in the ALPHA study suggests that Eclipsium integrates well into the standard laparoscopic workflow and offers a non-penetrating alternative to tacks. I look forward to its availability in Europe and to its potential to improve the patient experience after hernia repair."
Tissium is preparing for the European commercial introduction of Eclipsium, with an initial release expected in 2027. In parallel, the company is advancing clinical development in the United States. The first U.S. patients have been treated with the Eclipsium System in the UNITE study, a prospective, multicenter, randomized controlled trial conducted under an Investigational Device Exemption granted by the FDA.
Maria Pereira, Co-Founder, Deputy Chief Executive Officer and Chief Innovation Officer of Tissium, said: "When we started Tissium, we asked a simple question: what if surgeons could repair tissue without first having to damage it, the way it is currently done with penetrating fixation? For decades, sutures, staples and tacks have been the default, often at the cost of additional trauma. Seeing a technology we first imagined at the bench now authorized for patients on two continents is deeply rewarding. And it is only the beginning: as we bring Eclipsium to European surgeons and advance the rest of our pipeline, directly and through potential strategic partnerships, our ambition is to make atraumatic tissue reconstruction the new standard across surgery."
Source: Tissium
21.10.2026
