A New Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms

• Published in: Stroke (1970) Vol. 38; no. 8; pp. 2346 - 2352
• Main Authors: Kallmes, David F., Ding, Yong Hong, Dai, Daying, Kadirvel, Ramanathan, Lewis, Debra A., Cloft, Harry J.
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 01.08.2007
• Subjects: Animals; Biocompatible Materials - standards; Biocompatible Materials - therapeutic use; Biological and medical sciences; Blood Pressure - physiology; Cardiovascular system; Cerebral Angiography; Cerebral Arteries - diagnostic imaging; Cerebral Arteries - pathology; Cerebral Arteries - physiopathology; Cerebrovascular Circulation - physiology; Cerebrovascular Disorders - etiology; Cerebrovascular Disorders - physiopathology; Disease Models, Animal; Diseases of the nervous system; Embolization, Therapeutic - instrumentation; Embolization, Therapeutic - methods; Intracranial Aneurysm - diagnostic imaging; Intracranial Aneurysm - physiopathology; Intracranial Aneurysm - therapy; Intracranial Embolism - etiology; Intracranial Embolism - physiopathology; Intracranial Embolism - prevention & control; Medical sciences; Neurology; Pharmacology. Drug treatments; Prostheses and Implants - standards; Prostheses and Implants - trends; Rabbits; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Treatment Outcome; Vascular diseases and vascular malformations of the nervous system; Vasodilator agents. Cerebral vasodilators; Stroke; Nervous system diseases; Aneurysm; saccular aneurysm; Rabbit; Cardiovascular disease; Lagomorpha; Stent; Cerebral disorder; Vascular disease; Vertebrata; Mammalia; Treatment; Animal; Central nervous system disease; Cerebrovascular disease
• ISSN: 0039-2499; 1524-4628; 1524-4628
• DOI: 10.1161/STROKEAHA.106.479576

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.