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Original research
The SPEED study: initial clinical evaluation of the Penumbra novel 054 Reperfusion Catheter
  1. Don Frei1,
  2. Johannes Gerber2,
  3. Aquilla Turk3,
  4. Malia McPherson4,
  5. Don Heck5,
  6. Ferdinand Hui6,
  7. Gregory Joseph7,
  8. Reza Jahan8,
  9. Laszlo Miskolczi9,
  10. Jeffrey Carpenter10,
  11. Thomas Grobelny11,
  12. Jim Goddard12,
  13. Raymond D Turner3,
  14. Dan Huddle1,
  15. Richard Bellon1,
  16. Imran Chaudry3
  1. 1Swedish Medical Center, Englewood, Colorado, USA
  2. 2University of Dresden, Dresden, Germany
  3. 3Medical University of South Carolina, Charleston, South Carolina, USA
  4. 4Penumbra Inc, Alameda, California, USA
  5. 5Forsyth Medical Center, Winston-Salem, North Carolina, USA
  6. 6Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA
  7. 7Presbyterian Hospital, Charlotte, North Carolina, USA
  8. 8UCLA Medical Center, Los Angeles, California, USA
  9. 9Holy Cross Hospital, Fort Lauderdale, Florida, USA
  10. 10West Virginia University Medical Center, Morgantown, West Virginia, USA
  11. 11Christ Hospital, Oak Lawn, Illinois, USA
  12. 12Fairview Southdale Hospital, Edina, Minnesota, USA
  1. Correspondence to Dr Aquilla Turk, Medical University of South Carolina, 169 Ashley Ave, Charleston, SC 29435, USA; turk{at}musc.edu

Abstract

Background and purpose Revascularization of acute ischemic stroke from a large vessel occlusion continues to be a challenge with current thrombectomy devices. The purpose of the SPEED study was to report the safety and effectiveness of the Penumbra 054 Reperfusion Catheter System in revascularizing large vessel occlusions.

Methods In this retrospective multicenter study, data were collected from patients with angiographic evidence of large vessel occlusion treated with the Penumbra 054 device as the intended primary therapy. Clinical outcome data were collected with 90-day follow-up and the results were compared with those from the Penumbra Pivotal trial.

Results Eighty-seven target vessels in 86 consecutive patients treated with the Penumbra 054 device were included. The Thrombolysis In Myocardial Infarction (TIMI) 2 or 3 revascularization rate was 91% compared with a reported 82% in the Penumbra Pivotal trial. This was accomplished in a median time of 20 min compared with 45 min in the Penumbra Pivotal trial (p<0.0001). Eighteen (21%) patients experienced an intracranial hemorrhage of which 12 (14%) were symptomatic. Good neurologic outcome (modified Rankin scores ≤ 2) at 90-day follow-up was achieved in 34.9% of patients compared with 25% reported in the Penumbra Pivotal trial. All-cause mortality was 25.6%.

Conclusions These results suggest that the Penumbra 054 is a fast, safe and effective revascularization tool for patients experiencing ischemic stroke secondary to large vessel occlusive disease. Improvements in speed and effectiveness of revascularization probably contributed to improved outcomes.

  • Stroke
  • Catheter

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