title: Recanalization of femoropopliteal chronic total occlusions using the ENABLER-P Balloon Catheter System.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.affiliation: Herz-Zentrum, Bad Krozingen, Germany. thomas.zeller@herzzentrum.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Antonio M
authors.initials: AM
authors.lastname: Kambara
authors.forename: Samuel M
authors.initials: SM
authors.lastname: Moreira
authors.forename: Eliyahu
authors.initials: E
authors.lastname: Atar
authors.forename: Alexander
authors.initials: A
authors.lastname: Chulsky
authors.forename: Yoav
authors.initials: Y
authors.lastname: Turgeman
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Maurice
authors.initials: M
authors.lastname: Buchbinder
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D001938:Brazil; D057785:Catheters; D002908:Chronic Disease; D003251:Constriction, Pathologic; D004867:Equipment Design; D005240:Feasibility Studies; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000293:injuries; D005355:Fibrosis; D005858:Germany; D006801:Humans; D007557:Israel; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011446:Prospective Studies; D015641:Radiography, Interventional; D015607:Stents; D016896:Treatment Outcome; D061205:Vascular Calcification / Q000000981:diagnostic imaging / Q000628:therapy*; D057772:Vascular System Injuries / Q000209:etiology / Q000628:therapy