Nfocus Gets CE Mark Approval for Luna AES
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.
It is estimated that up to one in 15 people will develop a brain aneurysm during their lifetime. Rupture of an aneurysm can cause stroke, brain damage and even death, said Nfocus.
According to the company, the Luna AES treats brain aneurysms by blocking (embolizing) blood flow while providing a scaffold to encourage tissue growth across an aneurysm opening and create a plug. The Luna uses a self-expandable, multi-layer oval implant made from Nitinol, a nickel-titanium alloy.
The properties of the device allow it to easily compress within a conventional catheter, and then rapidly and easily open to full size once deployed within an aneurysm.
Eric Milledge, CEO of Nfocus Neuromedical, said: â€œBrain aneurysm treatment historically has been the domain of either surgery or, more recently, catheter-placed wire coils. Surgery can be traumatic and expensive, and coils may fail to fully treat an aneurysm. The Luna AES represents a dramatic step forward in the treatment of these patients.â€
Robert O'Holla, vice president of regulatory affairs at Nfocus Neuromedical, said: â€œCE Mark approval is an important milestone for Nfocus. The Luna AES is our flagship product and we look forward to working with physicians and hospitals in Europe to advance this important new technology.â€
Can the company successfully market the new system?
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