Nfocus Neuromedical has reported positive one-year follow-up results from an ongoing clinical study of its Luna Aneurysm Embolization system (AES).
CE-marked Luna AES is an oval shaped self-expandable, multi-layer, Nitinol alloy-based implant which is designed as a treatment for both pre- and post-rupture brain aneurysms.
Luna AES 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 up to one year and can be delivered within 15 minutes to locations where 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.
Study principal investigator Piotins 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," Piotins added.
Nfocus Neuromedical president and COO Martin Dieck said the Luna AES has the potential to reduce procedure times and improve the outcomes of aneurysm treatment.
"We expect to present final results from this study in a formal journal and scientific session in 2013," Dieck added.
The company said the ongoing study will support a commercial launch of Luna AES in 2013.
