Document Detail


Recanalization of Femoropopliteal Chronic Total Occlusions Using the ENABLER-P Balloon Catheter System.
MedLine Citation:
PMID:  22545874     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Abstract Purpose: To evaluate the safety and effectiveness of a new system to facilitate intraluminal advancement of conventional guidewires through chronic total occlusions (CTO) of the superficial femoral artery (SFA) and popliteal artery. Methods: The ENABLER-P Balloon Catheter System uses a unique balloon-anchoring mechanism and an automated balloon inflation device for steady, controlled advancement of a standard non-hydrophilic guidewire. The system was evaluated in 37 patients (22 men; mean age 67 years (range 41-87) with femoropopliteal CTOs averaging 86 mm in length (range 10-340). The device was used in a variety of occlusions, including heavily calcified, long, and fibrotic lesions. After successful guidewire recanalization facilitated by the system, occluded arterial segments were treated conventionally with balloon angioplasty, atherectomy, and stents as appropriate. Results: The primary endpoint of successful crossing was achieved in 86% (32/37) of the overall study population. The average activation time for successful crossing was 5.3 minutes (range 0.4-22). Of the 32 cases successfully crossed with the ENABLER-P System, all but 1 was successfully recanalized. One (3%) device-related complication occurred when the wire was advanced into a side branch when treating a 300-mm-long flush ostial SFA occlusion; the resulting perforation was managed with a covered stent without further sequelae. Conclusion: This novel system, which provides enhanced force to a standard guidewire tip for controlled intraluminal advancement, is a promising device for the treatment of peripheral CTOs.
Authors:
Thomas Zeller; Antonio M Kambara; Samuel M Moreira; Eliyahu Atar; Alexander Chulsky; Yoav Turgeman; Sebastian Sixt; Gunnar Tepe; Aljoscha Rastan; Maurice Buchbinder
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists     Volume:  19     ISSN:  1545-1550     ISO Abbreviation:  J. Endovasc. Ther.     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-05-01     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100896915     Medline TA:  J Endovasc Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  131-9     Citation Subset:  IM    
Affiliation:
1  Herz-Zentrum, Bad Krozingen, Germany.
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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