The Pounce™ Venous Thrombectomy System has demonstrated improvements in patient quality of life measures and disease severity scores at 12 months compared to baseline (p < 0.001).1
Villalta Score1: Median, [IQR], (N)
Baseline: 15.0, [7.0, 18.5], (19)
6 Month: 3.0, [1.0, 5.0], (13)
12 Month: 2.0, [1.5, 3.0], (11)
p < 0.001
Villalta score is a measurement tool that categorizes the severity of Post-Thrombotic Syndrome (PTS). A score >4 (or presence of a venous ulcer) indicates the presence of PTS. A score >14 indicates severe PTS disease.2
VCSS Score1: Median, [IQR], (N)
Baseline: 8.5, [7.0, 10.0], (16)
6 Month: 2.0, [2.0, 5.0], (13)
12 Month: 2.0, [1.5, 3.0], (11)
p < 0.001
Venous Clinical Severity Score (VCSS) may be used to assess changes in response to a given therapy. A total of 10 clinical descriptors are used (pain, varicose veins, etc.) are used to score disease severity (the worst being a score of 30).3
VCSS Score1: Median, [IQR], (N)
Baseline: 8.5, [7.0, 10.0], (16)
6 Month: 2.0, [2.0, 5.0], (13)
12 Month: 2.0, [1.5, 3.0], (11)
p < 0.001
Venous Clinical Severity Score (VCSS) may be used to assess changes in response to a given therapy. A total of 10 clinical descriptors are used (pain, varicose veins, etc.) are used to score disease severity (the worst being a score of 30).3
Study Population: patients with symptomatic peripheral vascular thrombus, defined as acute unilateral venous thrombus (≤14 days symptomatic) who met the inclusion and exclusion criteria5
| Baseline Patient Characteristics (N=19)5 | |
|---|---|
| Median Age (years) | 58 (IQR 34-69) |
| Median BMI (kg/m2) | 29 (IQR 24-32) |
| Gender Female Male |
14 (74%) 5 (26%) |
| Index Leg Left Leg Right Leg |
14 (74%) 5 (26%) |
| Procedural Considerations (N=19) | |
|---|---|
| Popliteal Vein Access5 | 19 (100%) |
| Stent Placement, Post-Thrombectomy5 | 14 (74%) |
| Mean Treatment Lesion6 (cm) | 15.3 |
ClinicalTrials.gov Information
Study Name: The Venous Thrombus Extraction (VETEX) Clinical Study: A Preliminary Investigation (VETEX)
ClinicalTrials.gov Identifier: NCT03489135
https://www.clinicaltrials.gov/ct2/show/NCT03489135?term=Vetex&draw=2&rank=1
TR141, Rev 1, 2021
Scoring Systems for the Post-Thrombotic Syndrome, Journal of Vascular Surgery, Volume 57, Number 1, p. 254, Soosainathan et al
Validation of Venous Clinical Severity Score (VCSS) with other venous severity assessment tools from the American Venous Forum, National Venous Screening Program, Journal of Vascular Surgery, Volume 54, Number 19S, p 3S Passman et al
An overview of the most commonly used venous quality of life and clinical outcome measurements, Journal of Vascular Surgery: Venous and Lymphatic Disorders, July 2015, p.338, Catarinella et al
TR121, Rev2, 2020
TR119, Rev1, 2020