Intervene, Inc.
The goal of this observational study is to gather additional safety and performance (effectiveness) data on the device for the treatment of symptomatic lower extremity venous obstructions and occlusions. The main questions the study aims to answer are: * What is the observed rate of safety events through the 30-day follow-up? * What is the rate of technical success (acute procedural success) achieved at the index procedure? Participants already undergoing treatment with the Recana as part of their regular medical care will be followed for 1 year.
The CALIBER Registry is a prospective, multi-center, non-randomized, non-interventional (observational) registry of the Recana Thrombectomy Catheter System for the treatment of symptomatic venous obstructions. Commensurate with the continuum of care and usual practice for the follow-up of the study population, subjects are assessed at post-procedure/discharge, 30-day (30D), 180-day (180D) and 365-day (365D) post-index procedure \[reporting on these timepoints are based on standard of care clinic visits that occur closest to timepoints at 30D, 180D and 365D post-procedure\].
INCLUSION CRITERA: A. Native Vessel: 1. INC-1: Subject is 18 years or older 2. INC-2: Subject has lower extremity venous obstruction involving the femoral, common femoral, and iliac veins, and inferior vena cava (IVC), alone or in combination, who, in the opinion of the investigator, would benefit from treatment with the Recana 3. INC-3: Recana Thrombectomy Catheter System must enter the vasculature 4. INC-4: Willing and able to provide written informed consent B. In-Stent Restenosis: 1. INC-1: Subject is 18 years or older 2. INC-2: Subjects with stents implanted greater than 6 weeks prior…
Recanalization and debulking with the Recana Thrombectomy Catheter System
Arctuva estimate
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