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TruePath: A Powerful new solution for intraluminal treatment of chronic total occlusions.
|Shaping Tool||Motor Housing||Control Unit|
|H74939208181650||39208-18165||TruePath CTO Device|
|H74939208001601||39208-00160||TruePath Extension Wires (5/box)|
|Size (OD)||Length||Sheath Compatibility||Min. Guide Catheter ID||Tip Profile|
|0.018" / 0.46 mm||165 cm||≥ 0.018" / 0.46 mm compatible Catheters¹||≥ 0.018" / 0.46 mm||0.017" / 0.43 mm|
Demonstrate that TruePath CTO Device is safe and effective to facilitate crossing infrainguinal artery CTOs following resistance to crossing with a conventional guidewire or a prior failed attempt.
- 85 Subjects
- 3 centers in Europe
|Key Clinical Results|
|All Patients: (n=85)|
|Freedom from clinical perforation (any perforation requiring treatment) of the index lesion to 30 days||98.8% (*84/85)|
|Facilitation of crossing the CTO with the TruePath CTO Device and/or any guidewire||80.0% (68/85)|
|Length of Occlusion||< 100 mm||38.8%|
|101 mm – 200 mm||30.6%|
|201 mm – 450 mm||30.6%|
|Mean Length of Occlusion||166.0 mm|