SAVVE® U.S. Pivotal Trial: One Year Definitive Data
%
Clinical Meaningful Benefit Responder Rate*
Point Average rVCSS Improvement**
%
Median Reduction in Pain (VAS)
%
Median Ulcer Area Reduction
%
Target Vein Patency Rate
85% of the SAVVE Patients Went From Having Severe CVI to a More Mild Form of the Disease or No Disease At All
*Clinically meaningful benefit of a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS)
**For the clinically meaningful benefit responder cohort
Improvement in Patient Reported Quality-of-Life Indicators
%
VEINES Symptom Score*
%
VEINES Qol Score*
*Mean (± SD): The VEINES scoring system consists of two composite scores – one for quality of life and one for symptom severity
rVCSS: Clinically Meaningful Benefit
Percentage of Patients with Clinical Meaningful Benefit at Follow Up
- 3 Months 71%
- 6 Months 74%
- 12 Months 85%
rVCSS Point Improvement
Point Improvement in Average rVCSS Clinical Meaningful Benefit
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rVCSS is a clinically validated scoring system used to track the regression or progression of venous diseases
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Percentage Ulcer Reduction
Patency
Target Vein Patency Rate
Device Patency
30 DAYS
12 MONTHS
12 MONTHS
%
%
%
Target Vein Patency Rate
30 DAYS
%
12 MONTHS
%
Device Patency
12 MONTHS
%
Procedural Outcomes
PROCEDURAL
SUCCESS RATE
INTRA-OPERATIVE
DEVICE PATENCY
%
%
Procedural Outcomes
PROCEDURAL
SUCCESS RATE
%
INTRA-OPERATIVE
DEVICE PATENCY
%
Major Adverse Events (MAEs) at 1 Year
-
(1) Death (unrelated to the VenoValve) ⎮ Zero (0) Pulmonary Embolisms ⎮ Twelve (12) Target Vein Thromboses ⎮ Ten (10) Surgical Pocket Hematomas ⎮ Four (4) Other Bleeds ⎮ Seven (7) Deep Wound Infections
-
Percent (94%) of the subjects who experienced an MAE (not including the unrelated death) also experienced a clinical meaningful benefit