Abstract 187: Magnetically-Enhanced Diffusion (MED™) of intravenous tPA in Acute Ischemic Stroke: A Pilot Safety and Feasibility Trial
Background: The MED device (Pulse Therapeutics, St. Louis, MO) uses an external magnet system and IV-administered magnetic particles to enhance delivery tPA within stagnant-flow vessels. We present the first human data from a safety feasibility study examining the utility of the technology for large-vessel intracranial occlusions.
Methods: AIS patients (63-91y; median 82y) with acute M1 or M2 occlusions were treated within 4.5hrs of symptom onset. Magnetic particles were concurrently delivered to standard-dose IV-tPA. TICI Grade flow in the target vessel segment was assessed prior and post therapy via CTA and/or MRA.
Results: Seven patients were enrolled with M1(6) and M2(1) arterial occlusion, with clot length >6mm [2(6-8mm), 4(8-10mm), 1(>25mm)]. Median baseline NIHSS was 16(3-24). All patients receiving post-therapy imaging demonstrated early recanalization (+3pnt median TICI improvement, FIGURE) accompanied with 24hr NIHSS improvement (3-15pnts; median 15pnts), sustained out to 90d. One delayed hemorrhage (9hrs post onset) was identified, however, immediate post-therapy imaging showed complete recanalization without hemorrhage. Reversible transient acute hypotension was observed in 5 patients during particle/tPA infusion. This response is associated with particle surface charge.
Conclusion: These early data support the safety and efficacy of the MED system for enhancing the efficacy of IV tPA in an Emergency Department environment. Further studies will involve modifications of particle surface charge.
Author Disclosures: C. Bladin: None. C. Levi: None. M. Parsons: None. B. Campbell: None. P. Panagos: Speakers' Bureau; Modest; Genentech. Consultant/Advisory Board; Modest; Pulse Therapeutics, IC. C. Derdeyn: Ownership Interest; Modest; Pulse Therapeutics. Consultant/Advisory Board; Modest; Microvention, Penumbra, Silk Road, Pulse Therapeutics. F. Creighton: Employment; Significant; Pulse Therapeutics. Ownership Interest; Significant; Pulse Therapeutics.
- © 2015 by American Heart Association, Inc.