- Luna devices have demonstrated stability up to one year post-implantation -
PALO ALTO, Calif., July 25, 2012 /PRNewswire/ -- Nfocus Neuromedical, Inc., an innovative medical device company with a focus on the next generation treatment for brain aneurysms, announced today positive data from an ongoing clinical study of the company's Luna™ Aneurysm Embolization System (AES). Michel Piotin, MD, PhD, of the Foundation Rothschild, Paris, presented the data today at the Society for Neurointerventional Surgery (SNIS) Annual Meeting in San Diego, Ca.
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.
"I am pleased to be part of this formal clinical trial to evaluate the Luna in intracranial aneurysms," said Dr. Piotin, 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."
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.
It is estimated that up to one in 15 people will develop a brain aneurysm during their lifetime.1 Rupture of an aneurysm can cause stroke, brain damage and even death.
Traditionally, medical professionals have treated aneurysm with surgery and, more recently, catheter-placed wire coils. Surgery can be traumatic and expensive, with high rates of morbidity and mortality. To treat aneurysm with coils, surgeons frequently must implant multiple coils, a process that can take hours. 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 blocking (embolizing) blood flow while providing a scaffold to encourage tissue growth across an aneurysm opening and create a plug. The Luna is a self-expandable, multi-layer oval implant made from Nitinol, a nickel-titanium alloy.
"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."
The Luna device has received CE Mark; the ongoing study is designed to support a 2013 commercial launch. "The results presented by Dr. Piotin today are encouraging but still preliminary," said Dieck. "We expect to present final results from this study in a formal journal and scientific session in 2013."
About Nfocus Neuromedical, Inc.
Nfocus is developing the next generation treatment for brain aneurysms. The company's innovative LUNA™ product is a single-deployment, easy-to-use embolization device designed to be a direct replacement to detachable coils. Nfocus is backed by four major U.S.- and OUS-based venture funds: Technology Partners, DFJ ePlanet Capital, InCube Ventures, and Raffles Venture Partners. More information can be found at www.nfocusneuro.com.
SOURCE Nfocus Neuromedical, Inc.