Integra gets US approval for next-gen dural graft:
This article was originally published in Clinica
Executive Summary
Integra NeuroSciences - a division of Integra LifeSciences Holdings - has received 510(k) clearance from the US FDA for its DuraGen XS dural regeneration matrix. The graft, for the sutureless closure of defects in the dura mater, has a higher collagen content while maintaining the same porous structure as Integra's previous generation materials, said the Plainsboro, New Jersey firm. Integra estimates that the graft has the potential to be used in around 225,000 neurosurgical procedures a year in the US. The dura mater is a tough fibrous membrane that surrounds and protects the brain and spinal cord. Head and spinal injuries, as well as neurosurgical procedures, can result in the rupture of the membrane, which must then be resealed in order to prevent the leaking of cerebrospinal fluid and to facilitate wound healing.
You may also be interested in...
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches
UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.