title: The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe.
abstract: OBJECTIVE
  The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application.
  
  
  METHODS
  A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial.
  
  
  RESULTS
  A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not.
  
  
  CONCLUSIONS
  Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.
authors: University Hospital, Cleveland, Ohio 44106, USA. robert.tarr@uhhospitals.org
authors: Robert
authors: R
authors: Tarr
authors: Dan
authors: D
authors: Hsu
authors: Zsolt
authors: Z
authors: Kulcsar
authors: Christophe
authors: C
authors: Bonvin
authors: Daniel
authors: D
authors: Rufenacht
authors: Karsten
authors: K
authors: Alfke
authors: Robert
authors: R
authors: Stingele
authors: Olav
authors: O
authors: Jansen
authors: Donald
authors: D
authors: Frei
authors: Richard
authors: R
authors: Bellon
authors: Michael
authors: M
authors: Madison
authors: Tobias
authors: T
authors: Struffert
authors: Arnd
authors: A
authors: Dorfler
authors: Iris Q
authors: IQ
authors: Grunwald
authors: Wolfgang
authors: W
authors: Reith
authors: Anton
authors: A
authors: Haass
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000628:therapy*; D002548:Cerebral Revascularization / Q000009:adverse effects / Q000295:instrumentation*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D061185:Mechanical Thrombolysis / Q000009:adverse effects / Q000295:instrumentation*; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D020521:Stroke / Q000628:therapy*; D013396:Suction / Q000295:instrumentation; D016896:Treatment Outcome; D014481:United States