SAVVE® U.S. Pivotal Trial

Initial Positive 11-Month Topline Efficacy Data From SAVVE Trial* 

  • Overall 8.46 Average Revised Venous Clinical Severity Score (rVCSS) Improvement Per Patient for Patients Showing Clinical Meaningful Benefit (rVCSS Improvement ≥ 3 Points) including:
    • 9.29 Points for Patients at the Two-Year Milestone
    • 8.08 Points for Patients at the One-Year Milestone
    • 8.71 Points for Patients at the Six-Month Milestone
  • 72% of the Study Patients Showing Clinical Meaningful Benefit from the VenoValve at a Weighted Average of 11 Months Post Surgery

  • 94% of VenoValve Study Patients Showing Clinical Improvement at a Weighted Average of Eleven Months Post Surgery (rVCSS Improvement ≥ 1 point)

* Data compared to baseline

Preliminary 11 Month Efficacy Data From SAVVE Trial

Topline Efficacy Data 

Clinical Improvement

Improvement in rVCSS
  • 94% 94%
94% of VenoValve Study Patients Showing Clinical Improvement at a Weighted Average of Eleven Months Post Surgery (rVCSS Improvement ≥ 1 point)

Clinical Meaningful Benefit

≥ 3 Point Improvement in rVCSS
  • 72% 72%
72% of the Study Patients Showing Clinical Meaningful Benefit from the VenoValve at a Weighted Average of 11 Months Post Surgery (Improvement in rVCSS of 3 or More Points)

Average rVCSS Improvement per Patient Showing Clinical Meaningful Benefit of 8.46 Points, More Than Two and a Half Times the Amount Needed to Show the VenoValve’s Clinically Meaningful Benefit

Compelling Device Related Safety Profile at 30 Days:*  

0

No
Deaths

0

No Pulmonary
Embolisms

8%

Deep Vein Thrombosis
(DVT)**

*A higher than expected rate of procedure related pocket wound hematomas and wound infections was observed, with no negative impact on clinical improvement.
**Adjudication: 4 Mild; 2 Moderate. 5 of 6 DVT patients showing clinical improvement

Ulcer Healing

Overview:

Preliminary 11 Month Efficacy Data

Preliminary Efficacy Data:

Clinical Meaningful Benefit Cohorts

Preliminary Efficacy Data:

rVCSS Cohorts Subanalyses

Patients with C4b/c, C5 and C6 are all benefiting from the VenoValve at 11 months compared to baseline. 

Device Related MAEs (30 day) 

*A higher than expected rate of procedure related pocket wound hematomas and wound infections was observed, with no negative impact on clinical improvement.

Principal Investigators from Leading Surgical Centers Around the United States

 

Study Design:

Prospective, Non-Blinded, Single Arm, Multi-Center Study

Primary
Safety Endpoint

30 DAYS

Efficacy Endpoints

180 DAYS

Inclusion:

Failure of at Least 3 Months Standard Care 

Axial Reflux >1 Second 

Valvular Incompetence (Primary or Secondary) 

CEAP Score: C4b, C5, C6 

Ability to Ambulate Without Assistance 

ABI >.61 

BMI <40 

Exclusion:

Hypercoagulable Condition 

Acute Deep Venous Thrombosis or Pulmonary Embolism 

Lymphedema 

Superficial Reflux 

Iliac/IVC Obstruction or Poor Central Venous Flow 

Uncontrolled Diabetes Mellitus 

Sepsis 

Patient Characteristics

Demographics:

Age: 63 [38 – 83] 

Mean BMI: 32.3 

Male: 81.3% (N=61) 

Race 
  White: 86.7% (N=65) 
  African American: 12.0% (N=9) 
  Other: 1.3% (N=1) 

CEAP Classification:

70.5% (N= 31) of Patients With C6 Disease Had Ulceration for More Than One Year 

C4b: 5/75 (6.7%) 
C4c: 5/75 (6.7%) 
C5: 21/75 (28.0%) 
C6: 44/75 (58.7%) 

    Comorbidities:

    Diabetes: 32.0% (N=24) 

    Peripheral Artery Disease: 6.7% (N=5) 

    Chronic Venous Insufficiency

    VenoValve®

    Publications

    The VenoValve® and enVVe® are investigational medical devices currently in development. Neither device is approved or cleared for any indication in any market. The VenoValve® is only available for use in the United States in pre-market clinical studies.