Interim results of Part I: Recanalization was demonstrated in 54.1% (60 of the 111 patients enrolled) in part 1 who were treated with device alone. Of those treated with both the device and tPA, recanalization was seen in 69.4% (n=77). Adverse complications due to the procedure occurred in 11 (9.9%) of the patients. 90-day mRS scores of 2 or less were observed in 34.3% of all patients in which the device was deployed. Total mortality was 30.6% (n=33). Final results of Part I and Part II: Recanalization was demonstrated in 54.9% (90/164) after use of the device alone. Recanalization was achieved in 68.3% (112/164) following use of the device and adjuvant treatment. Clinically significant procedural complications occurred in 5.5% (9/164) of patients. 90-day mRS scores of 2 or less were observed in 36% of all patients. Mortality at 90-days was 34%.