New Stroke Technology: Stent and Pressure Activated Nanoparticles to Bust Clots

November 6th, 2015 Editors Nanomedicine, Neurology, Neurosurgery

Some ischemic strokes are now successfully treated using intravascular clot retrieval devices, but in many instances this option is not advised. Moreover, the retriever can dislodge bits of the clot that end up embolizing deeper into the brain. Clot busting drugs, on the other hand, can’t get into a complete occlusion since there’s no blood flow. A team from Harvard’s Wyss Institute and University of Massachusetts’ New England Center for Stroke Research have developed a new approach that combines a device that creates a tunnel through the clot with pressure activated nanoparticles that release clot busting drugs when passing through the narrow channel.

The particles mimic how platelets stick to vessel walls where blood undergoes high pressures. Tissue plasminogen activator (tPA) coated over the nanoparticles release when the particles stick to the clot, dissolving it quickly at the point of occlusion. Any dislodged bits of the clot should also get a nanoparticle or two stuck to them. So as they travel down the vasculature they continue to be dissolved to prevent further harm. The stent that’s driven through the initial clot remains in place during the introduction of the nanoparticles and is retrieved at the end of the procedure.

Study in journal Stroke: Shear-Activated Nanoparticle Aggregates Combined With Temporary Endovascular Bypass to Treat Large Vessel Occlusion…

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Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

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How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

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Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
What to expect from the changes in ORA with Inspection Structure Realignment

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october 18 (Thursday) - 19 (Friday)

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Compliance Online 80068SEM

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