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% 71%
  • 6 Months 74% 74%
  • 12 Months 85% 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

  • One (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.

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