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 Improvement by CEAP Class
Point Change 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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Pain (VAS) – One Year
Percent Improvement in Median VAS Scores at 12 Months
Percentage Ulcer Reduction
%
Median Ulcer Area Reduction
Percentage Avg Ulcer Area (cm2) Reduced
Per Ulcer Duration
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
Patient Characteristics
The SAVVE® US Pivotal Trail enrolled 75 patients across 21 clinical sites. Application for premarket approval is pending with the FDA and the device has not been approved for marketing or sale in the United States or elsewhere.
