Evaluation of a new vascular occlusion device.
OBJECTIVE
A new vascular occlusion device was tested in canine femoral and iliac arteries and in an animal model of a patent ductus arteriosus (PDA).


METHODS
Four variations of the vascular plug were placed into 18 iliac or femoral arteries of 17 mongrel dogs. Follow-up angiography was performed 1 hour and, if necessary, 2 hours after placement in all animals, 14 of which were then killed. Three dogs were followed angiographically for 2 weeks to 3 months. The "butterfly" plug was then tested in a canine model of a PDA.


RESULTS
All plugs contained thrombi, and 12 of the 18 devices caused complete or nearly complete vascular occlusion within 2 hours. In one dog, one vascular plug had eroded through the vessel wall at 3 months without clinical sequelae. Successful PDA occlusion was achieved in 1 or 2 days in 6 of 8 dogs. Three misplacements occurred, one of which resulted in death.


CONCLUSIONS
The balloon-expandable vascular plug appears to be a promising device for occlusion of blood vessels. Migration has not been observed once the device is placed, thus, sizing of the device appears less critical than with coils. However, modification of the delivery system and considerably more experience with the device are necessary to reduce the risk of misplacement.
Nazarian
G K
GK
Department of Radiology, University of Minnesota Hospital and Clinic, Minneapolis 55455-0392.
Qian
Z
Z
Vlodaver
Z
Z
Pozza
C H
CH
Castañeda-Zúñiga
W R
WR
Hunter
D W
DW
Amplatz
K
K
D000818:Animals; D001027:Aortography; D004195:Disease Models, Animal; D004285:Dogs; D004374:Ductus Arteriosus, Patent / Q000000981:diagnostic imaging / Q000209:etiology / Q000473:pathology / Q000628:therapy; D004621:Embolization, Therapeutic / Q000295:instrumentation* / Q000706:statistics & numerical data; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D005263:Femoral Artery; D005500:Follow-Up Studies; D007083:Iliac Artery; D011651:Pulmonary Artery / Q000000981:diagnostic imaging / Q000473:pathology; D013193:Stainless Steel; D015607:Stents; D013927:Thrombosis / Q000209:etiology
D013193:Stainless Steel