Penumbra has announced the Shonin approval by the Japanese Ministry of Health, Labor and Welfare of the Penumbra Coil 400 for treatment of intracranial aneurysms.
According to a company release, the Penumbra Coil 400 is two to four times larger in volume than a conventional coil. It is also capable of tighter packing, allowing greater occlusion density, which can improve long-term outcomes.
“The Penumbra Coil 400 is the first major advance to significantly affect endovascular coiling technology since the original platinum detachable coil,” said Nobuyuki Sakai, director, Neurosurgery and Stroke Center at Kobe City Medical Center General Hospital, Hyogo, Japan. “We are proud and excited to have this technology in Japan and very much look forward to its use treating our intracranial aneurysm patients,” said Sakai.
“I have been impressed with the ability of the Penumbra Coil 400 to durably occlude aneurysms quickly and efficiently in the wide range of aneurysms we treat. We are now seeing encouraging follow-ups and complete occlusion in aneurysms that would have been vulnerable,” said Aman Patel, professor of Neurosurgery and Radiology, Mt Sinai School of Medicine, New York, USA. “I am looking forward to introducing my colleagues in Japan to this remarkable new technology.
It will be exciting to see an innovation like this take hold in a new market. Japanese neurosurgeons will now have an important alternative to treat brain aneurysms.”
Penumbra, together with its exclusive distribution partner, Medico’s Hirata, will immediately begin the launch of the device in Japan.