title: The SPEED study: initial clinical evaluation of the Penumbra novel 054 Reperfusion Catheter.
abstract: OBJECTIVE
  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.
authors.affiliation: Swedish Medical Center, Englewood, Colorado, USA.
authors.forename: Don
authors.initials: D
authors.lastname: Frei
authors.forename: Johannes
authors.initials: J
authors.lastname: Gerber
authors.forename: Aquilla
authors.initials: A
authors.lastname: Turk
authors.forename: Malia
authors.initials: M
authors.lastname: McPherson
authors.forename: Don
authors.initials: D
authors.lastname: Heck
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Hui
authors.forename: Gregory
authors.initials: G
authors.lastname: Joseph
authors.forename: Reza
authors.initials: R
authors.lastname: Jahan
authors.forename: Laszlo
authors.initials: L
authors.lastname: Miskolczi
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Carpenter
authors.forename: Thomas
authors.initials: T
authors.lastname: Grobelny
authors.forename: Jim
authors.initials: J
authors.lastname: Goddard
authors.forename: Raymond D
authors.initials: RD
authors.lastname: Turner
authors.forename: Dan
authors.initials: D
authors.lastname: Huddle
authors.forename: Richard
authors.initials: R
authors.lastname: Bellon
authors.forename: Imran
authors.initials: I
authors.lastname: Chaudry
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000175:diagnosis / Q000601:surgery*; D057785:Catheters / Q000592:standards*; D002548:Cerebral Revascularization / Q000295:instrumentation / Q000379:methods / Q000592:standards; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015424:Reperfusion / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D012189:Retrospective Studies; D020521:Stroke / Q000175:diagnosis / Q000601:surgery*; D015912:Thrombolytic Therapy / Q000379:methods / Q000592:standards; D016896:Treatment Outcome