The Penumbra System: a mechanical device for the treatment of acute stroke due to thromboembolism.
OBJECTIVE
Data from recent reports have indicated that mechanical thrombectomy may have potential as a treatment for acute ischemic stroke. The purpose of this study was to assess the safety and performance of the Penumbra System (PS): a novel mechanical device designed to reduce clot burden in acute stroke due to large-vessel occlusive disease.


METHODS
A prospective, single arm, independently monitored and core laboratory adjudicated trial enrolled subjects with an acute neurologic deficit consistent with acute stroke, presenting within 8 hours of symptom onset and an angiographically verified occlusion (Thrombolysis in Myocardial Infarction [TIMI] grade 0 or 1) of a treatable intracranial vessel. The primary end point was revascularization of the target vessel to TIMI grade 2 or 3. Secondary end points were the proportion of subjects who achieved a modified Rankin Scale (mRS) score of 2 or less or a 4-point improvement on the National Institutes of Health Stroke Scale (NIHSS) score at 30-day follow-up, as well as all-cause mortality.


RESULTS
Twenty-three subjects were enrolled, and 21 target vessels were treated in 20 subjects by the PS. At baseline, mean age was 60 years, mean mRS score was 4.6, and mean NIHSS score was 21. Postprocedure, all 21 of the treated vessels (100%) were successfully revascularized by the PS to TIMI 2 or 3. At 30-day follow-up, 9 subjects (45%) had a 4-point or more NIHSS improvement or an mRS of 2 or less. The all-cause mortality rate was 45% (9 of 20), which is lower than expected in this severe stroke cohort, where 70% of the subjects at baseline had either an NIHSS score of more than 20 or a basilar occlusion.


CONCLUSIONS
Thus, early clinical experience suggests that the PS allows revascularization in certain subjects experiencing acute ischemic stroke.
Bose
A
A
Lenox Hill Hospital, New York, NY, USA.
Henkes
H
H
Alfke
K
K
Reith
W
W
Mayer
T E
TE
Berlis
A
A
Branca
V
V
Sit
S Po
SP
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction; D002423:Cause of Death; D002533:Cerebral Angiography; D002544:Cerebral Infarction / Q000401:mortality / Q000601:surgery*; D017128:Embolectomy / Q000295:instrumentation*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D006801:Humans; D020766:Intracranial Embolism / Q000401:mortality / Q000601:surgery*; D020767:Intracranial Thrombosis / Q000401:mortality / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009460:Neurologic Examination; D011183:Postoperative Complications / Q000401:mortality; D011446:Prospective Studies; D017131:Thrombectomy / Q000295:instrumentation*; D014057:Tomography, X-Ray Computed