Revascularization Tool Approved by Feds
The Penumbra System, developed by Penumbra Incorporated, was approved by the FDA earlier this month according to a press release issued by the company. The product is a system used to complete revascularization for patients who had acute ischemic stroke resulting from intracranial large vessel occlusive disease. The company detailed the marketing clearance in a news release.
The Penumbra System is a package of components, including an aspiration platform, used by specialists in the interventional neurology setting. It is used to remove the offending occlusions in large brain vessels causing the stroke. The system works on the proximal surface of the occlusion. This eliminates the need to navigate into areas other than the stroke site and improves overall patient safety.
Included in the system are multiple devices that are created in varying sizes to match the delicate neuroanatomy of the occlusion. This enables simple removal of clots from intracranial vessels.
The Penumbra system is intended to treat patients who present within eight hours of the onset of symptoms. This is particularly beneficial because most of the treatment options currently available can only be used during the first three hours after symptoms commence, such as intravenous thrombolysis.
The device is planned for marketing immediately. It was approved for use in Europe and has been marketed there since mid summer last year.
January 10, 2008 Related topics: Product Approval & Certification, Psychiatry & Neurology