Ciliatech Secures CE Certification for Intercil Uveal Spacer Implant for Glaucoma
Ciliatech has obtained CE certification under the European Medical Device Regulation (MDR) for its Intercil Uveal Spacer, a surgical implant representing a first-of-its-kind procedure for glaucoma.
Intercil is the first device in a novel category of procedures termed 'Cilioscleral Interpositioning Devices (CID)'. Unlike traditional glaucoma surgeries, Intercil lowers IOP by enhancing uveoscleral outflow without penetrating the anterior chamber. According to Ciliatech, this “no-bleb-no-cleft” approach preserves anterior chamber integrity, potentially reducing risks such as corneal endothelial cell loss. Intercil creates a located gap between the ciliary muscle and the sclera which may decrease the element of resistance to the passage of aqueous humour into this area. This spacing may increase uveo-scleral flow to the choroidal circulation, leading to a physiological reduction of IOP. The technique also demonstrates a high safety profile, with fewer complications and smoother postoperative recovery.
The CE Mark clears the way for its commercial use across the European Union. Ciliatech has also registered the device in the UK, with plans for additional market expansion beginning there and extending into other key regions.
“Obtaining CE certification is a pivotal milestone and the culmination of years of hard work,” said Olivier Benoit, CEO of Ciliatech. “This will allow us to accelerate Intercil’s availability across Europe and prepare for registrations in the US and China. We believe glaucoma surgeons will see the value of our ‘no-bleb-no-cleft’ approach in delivering robust IOP control with minimal post-op care.”
According to Ciliatech, current surgical options have limitations, such as filtering surgeries (bleb-forming) carry infection risks and demand intensive follow-up; and conservative procedures may not sufficiently lower IOP due to natural physiological constraints. Intercil introduces a new treatment option for moderate glaucoma, a segment often underserved between mild cases managed with SLT or angle surgery and severe cases requiring filtering procedures. The device is also suitable for narrow-angle glaucoma patients.
Features of the Intercil Uveal Spacer include:
Anterior Chamber-free: Utilizes the supraciliary space without anterior chamber penetration
Robust IOP lowering: Effective for both Primary Open-Angle Glaucoma (POAG) and Primary Angle-Closure Glaucoma (PACG)
Versatile positioning: Can be implanted 360° around the eye
Broad applicability: Extends treatment possibilities to narrow-angle cases
“Intercil addresses the underserved need in treating moderate glaucoma. It bridges the gap between techniques for mild cases and filtering surgeries, providing surgeons with further options to manage disease progression. The device’s compatibility with narrow-angle cases further broadens its potential applicability, making it a versatile choice for diverse clinical needs across multiple patient populations,” Mr. Benoit said.
Ciliatech will present Intercil at the 4th ESCRS iNovation Day in Copenhagen on September 12.