CE Mark for Ciliatech’s Novel Glaucoma Implant

Ciliatech announced it received the CE Mark under the scope of the EU Medical Device Regulation (MDR) for Intercil, a uveal spacer offering a new approach to glaucoma treatment.

An ab externo device inserted between the sclera and ciliary body below the limbus, Intercil has been shown to provide reliable IOP reduction while lowering the risk of damaging the corneal endothelium, hyphaema, and postoperative inflammation, compared with procedures that penetrate the iris root.

“Ciliatech was created to develop an approach to glaucoma treatment that had never been considered previously: to lower IOP without entering the anterior chamber or creating subconjunctival filtration,” explained Ciliatech’s co-founder and medical director Philippe Sourdille MD. “This makes Ciliatech’s approach significantly different from existing surgical propositions. It provides procedural simplicity, with a fast learning curve. It does not inhibit future treatment options.”

The device is inserted through a penetrating 3.5 mm radial scleral incision 2.0 mm away from the limbus, which Dr Sourdille said offers the surgeon a precise view of the supraciliary body and allows creation of a space between the sclera and the muscle before inserting the device. It also leaves space for filtration surgery if that eventually is needed. The procedure takes about 15 minutes.

Intercil might be especially appropriate for phakic glauco­ma patients, said Karsten Klabe MD, a member of Ciliatech’s key opinion leader advisory board. “In addition to reducing the risk to the corneal endothelial cells by not opening the anterior chamber, there is less risk of cataract or damaging the iris. It might be safer [than angle-based or filtering glaucoma surgery] for such a group of patients.”

“Ciliatech is thrilled to obtain CE certification for our Intercil Uveal Spacer under the scope of MDR. This critical step is the culmination of years of hard work and significant investment,” said Olivier Benoit, CEO of Ciliatech in a company press release. His company was included in the emerging company section of the “Interventional Glaucoma in the Cataract Practice” session of iNovation Day.

“In our steadfast commitment to offering a genuine solution to patients who endure the impacts of glaucoma, and thanks to new funding, we can now accelerate the commercial availability of Intercil, roll out its distribution in select European countries, and plan for future registrations in key markets, notably the US and China. We anticipate that glaucoma surgeons and early adopters of innovation will see the value in our ‘no-bleb-no-cleft’ approach in achieving robust IOP lowering with minimal postoperative care.”

Intercil is the first in a brand-new class of glaucoma surgical procedure, ‘Cilioscleral Interpositioning Device’ (CID), designed to lower IOP by increasing uveoscleral outflow without penetrating the anterior chamber. This technique may preserve the integrity of the anterior chamber by using a ‘no-bleb-no-cleft’ approach, offering potential benefits in minimising the risk of corneal endothelial cell loss. CID transforms the way surgeons approach the supraciliary space of the eye, demonstrates a high safety profile, minimises complications, and provides a comfortable postoperative recovery for patients, the company reported.

Philippe Sourdille MD is an ophthalmologist, researcher, inventor, and medical director and co-founder of Ciliatech in Chavanod, France. p.sourdille@cilia.tech

Karsten Klabe MD is an ophthalmologist specialising in glaucoma surgery at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany. studien.k.klabe@augenchirurgie.clinic