Medtronic has obtained FDA approval for using its Pipeline Flex embolization system on sufferers with small to medium measurement mind aneurysm, between the petou and the & pétr an emb emb emb emb emb sufferers sufferers sufferers sufferers sufferers sufferers sufferers sufferers sufferers sufferers. finish of the interior carotid artery. Beforehand, the system was solely indicated for individuals with extensive or big wide-necked intracranial aneurysm.
The Pipeline Flex Move Diversion System redirects blood circulate by positioning itself simply on the base of the embolism, permitting the blood to circulate the complete size of the vessel.
Listed here are some particulars of the research that led to this newest approval, in keeping with Medtronic:
A complete of 141 topics with a median aneurysm measurement of 5.0 ± 1.92 mm have been analyzed. The info confirmed one-year occlusion charges of 76.7% with use of 1.1 system per topic on common and a 2.2% prevalence of main stroke. or neurological loss of life.
That is the second IDE (Investigations System Exemption) research for this implant that has been authorised by the FDA after finishing the "Pipeline for Stranded or Stranded Aneurysms" (PUF) trial, a research of 5 years involving big aneurysms wide-necked intracranier inner carotid artery (ACI) the place effectivity charges have been reported at 70.8% at 1 12 months after which at 95% in topics adopted by angiography on the 5-year interval. Within the PUF research, the general frequency of main strokes or neurological loss of life was 5.6%.4. There was no documented case of aneurysm recurrence in sufferers handled with the implant.
Product web page: Embolization System Pipeline Flex …
Through: Medtronic …