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SonoLysis Presents Clinical Trial Results Of Clot Busting Ultrasound Therapy

SonoLysis has announced that Phase I/II investigational clinical study results revealed that Combining transcranial Doppler (TCD) ultrasound with microspheres and the clot busting drug tissue plasminogen activator (tPA) is more effective than tPA alone in treating patients suffering from ischemic stroke. These results were presented at the American Stroke Association’s International Stroke Conference 2009. Carlos A. Molina, M.D., Stroke Neurologist from Vall d’Hebron Hospital in Barcelona, Spain and Andrei Alexandrov, M.D., Director of the University of Alabama’s Comprehensive Stroke Center has presented the clinical findings at the conference. These findings demonstrated that patients may be safely treated with TCD in combination with a specific dose of microspheres and tPA, a therapy called SonoLysis. Clinical results from the study also indicated that those study patients receiving SonoLysis treatment were two times more likely to have complete clearing of blocked arteries (recanalization) than those study patients receiving tPA alone. SonoLysis therapy, developed by ImaRx Therapeutics, leverages the energy from ultrasound waves to cavitate tiny gas-filled lipid microspheres within stroke-causing blockages to reopen arteries and restore blood flow. The multi-center, randomized, dose-ranging trial involving 35 patients evaluated 2 separate doses of ImaRx’s MRX-801 microspheres. Cohort I and Cohort II patients received 1.4 mL and 2.8 mL of microspheres respectively. Control patients received the standard dose of tPA alone. Sustained complete recanalization rates at the end of 36 hours were achieved in 67 percent of the Cohort I patients, 46 percent of the Cohort II patients, and 33 percent of the patients that received tPA only (controls) (p=0.255). In addition, the median time to any recanalization tended to be faster in the Cohort I patients (30 min, interquartile range 6) compared to 60 minutes (interquartile range 5) in control patients. Mean TIBI scores were higher for subjects who received 1.4 mL MRX-801 than for subjects who received control treatment at time points 30 minutes (p = 0.0075), 60 minutes (p = 0.0122), and 90 minutes (p = 0.0700) after initiation of study treatment. Three months following treatment, improvement in clinical outcomes (as measured by a Modified Rankin score) was reported in 75 percent of Cohort I patients, 50 percent of Cohort II patients and 36 percent of patients receiving tPA alone. Cohort I patients had a clinically significant outcome (p = 0.0424) compared to the control patients receiving tPA alone. Additionally, compared to baseline (pre-treatment time point), overall levels of neurological deficit (as measured by the NIHSS) were lower (improved) at time points (90 minutes, 120 minutes, 24-36 hours, and 90 days) after initiation of study treatment for each of the treatment groups. This improvement was most notable for subjects receiving 1.4 mL MRX-801, and the difference from control subjects was most evident at the 90-minute time point (p = 0.0369). No bleeding complications occurred in Cohort I or the controls, but three (27 percent) of the Cohort II patients experienced bleeding. Post study analysis revealed that the overall stroke severity was significantly higher in Cohort II with median NIHSS score of 16 versus 10 for the Cohort I (p=0.047). Additionally, all three patients that experienced bleeding complications in Cohort II also had uncontrolled hypertension.