Nfocus Neuromedical has reported positive one-year follow-up results from an ongoing clinical study of its LUNA aneurysm embolisation system (AES), designed as a treatment for both pre and post-rupture brain aneurysms.
CE marked Luna AES is an oval shaped, self-expandable, multilayer, Nitinol alloy-based implant which blocks blood flow and provides a scaffold to encourage tissue growth across an aneurysm by opening and creating a plug.
The initial one-year follow-up results demonstrated that implanted Luna devices have remained stable for up to one year, and can be delivered within 15 minutes to locations where the majority of aneurysms occur and to a wide variety of aneurysm types.
Initial results from the ongoing study also showed that anti-platelet therapy is not always necessary with the Luna device, as it carries the risk of bleeding complications.
Previously, medical professionals have treated aneurysms with surgery, that can be traumatic and used catheter-placed wire coils, which need hours to implant.
Dr. Piotins, study principal investigator, said a number of limitations exist with current aneurysm technologies including long procedure times.
"The Luna has been easy to work with and procedure times have been remarkably fast. The acute and long-term results to date are both very encouraging," Piotins added.
Martin Dieck, Nfocus Neuromedical president and COO, said the Luna AES has the potential to reduce procedure times and improve the outcomes of aneurysm treatment.
"The results presented by Dr. Piotin today are encouraging but still preliminary. We expect to present final results from this study in a formal journal and scientific session in 2013," Dieck added.
The ongoing study will support a commercial launch of Luna AES in 2013, according to the company.