It’s been SNIS 2012 this week, the annual meeting of the Society for Neurointerventional Surgery. Neuro device company Nfocus Neuromedical, Inc., has used the occasion to announce positive data from an ongoing clinical study of the company’s Luna Aneurysm Embolization System (AES).
It is estimated that up to one in 15 people will develop a brain aneurysm during their lifetime, rupture of such an aneurysm being likely to cause stroke, brain damage and even death.
Traditionally, medical professionals have treated aneurysm with surgery and, more recently, catheter-placed wire coils as we seem to have covered quite a bit recently on our pages. According to Nfocus’s news release, surgery can be traumatic and expensive, with high rates of morbidity and mortality, while treating with coils often requires multiple coils and can take hours. Furthermore the company says follow up with patients implanted with current coil technology often shows aneurysm re-growth or progression, requiring additional coils or other therapeutic approaches.
The Luna AES is designed to be a single-deployment, easy-to-use system for the treatment of brain aneurysms both pre- and post-rupture. The device treats aneurysms by embolising blood flow while providing a scaffold to encourage tissue growth across an aneurysm opening and create a plug. The Luna is described as a self-expandable, multi-layer oval implant made from Nitinol, a so-called memory metal.
According to the initial one-year follow-up results from the ongoing EU clinical study, implanted Luna devices have remained stable up to one year, a critical inflection point to measure success of a new technology. Clinical experience has also demonstrated that the Luna AES can be delivered quickly (within 15 minutes) to locations where the majority of aneurysms occur and to a wide variety of aneurysm types.
Initial results from this ongoing study also suggest that anti-platelet therapy a requirement with other stent flow-diverter technologies – is not always necessary with the Luna device. Anti-platelet therapy is expensive, doesn’t always work, and carries the risk of bleeding complications.
“I am pleased to be part of this formal clinical trial to evaluate the Luna in intracranial aneurysms,” said Michel Piotin, MD, PhD, of the Foundation Rothschild, Paris, the study principal investigator. “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.”
“The Luna AES is our flagship product and we have been exceptionally pleased with the clinical advantages it has demonstrated to date,” said Martin Dieck, president and COO, Nfocus Neuromedical. “This device has the potential to significantly reduce procedure times and improve the outcomes of aneurysm treatment.”
About the presentation at SNIS, Dieck commented “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.”
The Luna device carried the CE Mark and is the subject of ongoing study prior to a planned 2013 commercial launch in Europe.
Source: Nfocus Neuromedical, Inc., PR Newswire