A new endoluminal, flow-disrupting device for treatment of saccular aneurysms

David F Kallmes, Yong Hong Ding, Daying Dai, Ramanathan D Kadirvel, Debra A. Lewis, Harry J. Cloft

Research output: Contribution to journalArticle

286 Citations (Scopus)

Abstract

BACKGROUND AND PURPOSE - We report a preclinical study of a new endoluminal device for aneurysm occlusion to test the hypothesis that the device, even without use of intrasaccular coil placement, could occlude saccular aneurysms without causing substantial parent artery compromise or compromise of adjacent, small branch arteries. METHODS - The Pipeline Neuroendovascular Device (Pipeline NED; Chestnut Medical Technologies, Inc) is a braided, tubular, bimetallic endoluminal implant aimed at occlusion of saccular aneurysms through flow disruption along the aneurysm neck. The device was implanted across the necks of 17 elastase-induced aneurysms in the New Zealand white rabbit model and followed for 1 month (n=6), 3 months (n=5), and 6 months (n=6). In each subject, a second device was implanted in the abdominal aorta to cover the origins of lumbar arteries. Aneurysm occlusion rates by angiography (grade 1, complete occlusion; grade 2, near-complete occlusion; and grade 3, incomplete occlusion) were documented. Percent area stenosis of the parent arteries was calculated. Presence of distal emboli in the downstream vessels in the parent artery and branch artery stenosis or occlusion was noted. RESULTS - Grades 1, 2, and 3 occlusion rates were noted in 9 (53%), 6 (35%), and 2 (12%) of 17 aneurysms, respectively, indicating an 88% rate of complete or near complete occlusion. No cases of branch artery occlusion or distal emboli in the downstream vessels of the parent artery, specifically the subclavian artery, were seen. Parent artery compromise from neointimal hyperplasia was minimal in most cases. CONCLUSIONS - The Pipeline NED is a trackable, bio- and hemocompatible device able to occlude saccular aneurysms with preservation of the parent artery and small, adjacent branch vessels.

Original languageEnglish (US)
Pages (from-to)2346-2352
Number of pages7
JournalStroke
Volume38
Issue number8
DOIs
StatePublished - Aug 2007

Fingerprint

Aneurysm
Arteries
Equipment and Supplies
Embolism
Pathologic Constriction
Subclavian Artery
Pancreatic Elastase
Abdominal Aorta
Hyperplasia
Angiography
Neck
Rabbits
Technology

Keywords

  • Rabbit
  • Saccular aneurysm
  • Stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Neuroscience(all)

Cite this

A new endoluminal, flow-disrupting device for treatment of saccular aneurysms. / Kallmes, David F; Ding, Yong Hong; Dai, Daying; Kadirvel, Ramanathan D; Lewis, Debra A.; Cloft, Harry J.

In: Stroke, Vol. 38, No. 8, 08.2007, p. 2346-2352.

Research output: Contribution to journalArticle

Kallmes, David F ; Ding, Yong Hong ; Dai, Daying ; Kadirvel, Ramanathan D ; Lewis, Debra A. ; Cloft, Harry J. / A new endoluminal, flow-disrupting device for treatment of saccular aneurysms. In: Stroke. 2007 ; Vol. 38, No. 8. pp. 2346-2352.
@article{14164fda1c1144279dc0661c293fb095,
title = "A new endoluminal, flow-disrupting device for treatment of saccular aneurysms",
abstract = "BACKGROUND AND PURPOSE - We report a preclinical study of a new endoluminal device for aneurysm occlusion to test the hypothesis that the device, even without use of intrasaccular coil placement, could occlude saccular aneurysms without causing substantial parent artery compromise or compromise of adjacent, small branch arteries. METHODS - The Pipeline Neuroendovascular Device (Pipeline NED; Chestnut Medical Technologies, Inc) is a braided, tubular, bimetallic endoluminal implant aimed at occlusion of saccular aneurysms through flow disruption along the aneurysm neck. The device was implanted across the necks of 17 elastase-induced aneurysms in the New Zealand white rabbit model and followed for 1 month (n=6), 3 months (n=5), and 6 months (n=6). In each subject, a second device was implanted in the abdominal aorta to cover the origins of lumbar arteries. Aneurysm occlusion rates by angiography (grade 1, complete occlusion; grade 2, near-complete occlusion; and grade 3, incomplete occlusion) were documented. Percent area stenosis of the parent arteries was calculated. Presence of distal emboli in the downstream vessels in the parent artery and branch artery stenosis or occlusion was noted. RESULTS - Grades 1, 2, and 3 occlusion rates were noted in 9 (53{\%}), 6 (35{\%}), and 2 (12{\%}) of 17 aneurysms, respectively, indicating an 88{\%} rate of complete or near complete occlusion. No cases of branch artery occlusion or distal emboli in the downstream vessels of the parent artery, specifically the subclavian artery, were seen. Parent artery compromise from neointimal hyperplasia was minimal in most cases. CONCLUSIONS - The Pipeline NED is a trackable, bio- and hemocompatible device able to occlude saccular aneurysms with preservation of the parent artery and small, adjacent branch vessels.",
keywords = "Rabbit, Saccular aneurysm, Stent",
author = "Kallmes, {David F} and Ding, {Yong Hong} and Daying Dai and Kadirvel, {Ramanathan D} and Lewis, {Debra A.} and Cloft, {Harry J.}",
year = "2007",
month = "8",
doi = "10.1161/STROKEAHA.106.479576",
language = "English (US)",
volume = "38",
pages = "2346--2352",
journal = "Stroke",
issn = "0039-2499",
publisher = "Lippincott Williams and Wilkins",
number = "8",

}

TY - JOUR

T1 - A new endoluminal, flow-disrupting device for treatment of saccular aneurysms

AU - Kallmes, David F

AU - Ding, Yong Hong

AU - Dai, Daying

AU - Kadirvel, Ramanathan D

AU - Lewis, Debra A.

AU - Cloft, Harry J.

PY - 2007/8

Y1 - 2007/8

N2 - BACKGROUND AND PURPOSE - We report a preclinical study of a new endoluminal device for aneurysm occlusion to test the hypothesis that the device, even without use of intrasaccular coil placement, could occlude saccular aneurysms without causing substantial parent artery compromise or compromise of adjacent, small branch arteries. METHODS - The Pipeline Neuroendovascular Device (Pipeline NED; Chestnut Medical Technologies, Inc) is a braided, tubular, bimetallic endoluminal implant aimed at occlusion of saccular aneurysms through flow disruption along the aneurysm neck. The device was implanted across the necks of 17 elastase-induced aneurysms in the New Zealand white rabbit model and followed for 1 month (n=6), 3 months (n=5), and 6 months (n=6). In each subject, a second device was implanted in the abdominal aorta to cover the origins of lumbar arteries. Aneurysm occlusion rates by angiography (grade 1, complete occlusion; grade 2, near-complete occlusion; and grade 3, incomplete occlusion) were documented. Percent area stenosis of the parent arteries was calculated. Presence of distal emboli in the downstream vessels in the parent artery and branch artery stenosis or occlusion was noted. RESULTS - Grades 1, 2, and 3 occlusion rates were noted in 9 (53%), 6 (35%), and 2 (12%) of 17 aneurysms, respectively, indicating an 88% rate of complete or near complete occlusion. No cases of branch artery occlusion or distal emboli in the downstream vessels of the parent artery, specifically the subclavian artery, were seen. Parent artery compromise from neointimal hyperplasia was minimal in most cases. CONCLUSIONS - The Pipeline NED is a trackable, bio- and hemocompatible device able to occlude saccular aneurysms with preservation of the parent artery and small, adjacent branch vessels.

AB - BACKGROUND AND PURPOSE - We report a preclinical study of a new endoluminal device for aneurysm occlusion to test the hypothesis that the device, even without use of intrasaccular coil placement, could occlude saccular aneurysms without causing substantial parent artery compromise or compromise of adjacent, small branch arteries. METHODS - The Pipeline Neuroendovascular Device (Pipeline NED; Chestnut Medical Technologies, Inc) is a braided, tubular, bimetallic endoluminal implant aimed at occlusion of saccular aneurysms through flow disruption along the aneurysm neck. The device was implanted across the necks of 17 elastase-induced aneurysms in the New Zealand white rabbit model and followed for 1 month (n=6), 3 months (n=5), and 6 months (n=6). In each subject, a second device was implanted in the abdominal aorta to cover the origins of lumbar arteries. Aneurysm occlusion rates by angiography (grade 1, complete occlusion; grade 2, near-complete occlusion; and grade 3, incomplete occlusion) were documented. Percent area stenosis of the parent arteries was calculated. Presence of distal emboli in the downstream vessels in the parent artery and branch artery stenosis or occlusion was noted. RESULTS - Grades 1, 2, and 3 occlusion rates were noted in 9 (53%), 6 (35%), and 2 (12%) of 17 aneurysms, respectively, indicating an 88% rate of complete or near complete occlusion. No cases of branch artery occlusion or distal emboli in the downstream vessels of the parent artery, specifically the subclavian artery, were seen. Parent artery compromise from neointimal hyperplasia was minimal in most cases. CONCLUSIONS - The Pipeline NED is a trackable, bio- and hemocompatible device able to occlude saccular aneurysms with preservation of the parent artery and small, adjacent branch vessels.

KW - Rabbit

KW - Saccular aneurysm

KW - Stent

UR - http://www.scopus.com/inward/record.url?scp=34548250908&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=34548250908&partnerID=8YFLogxK

U2 - 10.1161/STROKEAHA.106.479576

DO - 10.1161/STROKEAHA.106.479576

M3 - Article

C2 - 17615366

AN - SCOPUS:34548250908

VL - 38

SP - 2346

EP - 2352

JO - Stroke

JF - Stroke

SN - 0039-2499

IS - 8

ER -