SAVVE® U.S. Pivotal Trial
Initial Positive Efficacy Data From SAVVE Trial
11-Month Topline Revised Venous Clinical Severity Score (rVCSS) Improvement*
• 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
12 Month Ulcer Healing Data Showing Significant Improvement
• 91% of Venous Ulcer Patients Evaluated at One Year Have Either Fully Healed Ulcers or Ulcers That Have Improved
• 100% of Venous Ulcers with a Duration of One Year or Less Prior to VenoValve Surgery Have Fully Healed
• 89% of Venous Ulcers with a Duration of More Than One Year Priot to VenoValve Surgery have Fully Healed or Improved
• No Ulcer Recurrences
Venous Ulcer Healing
Topline Efficacy Data
Clinical Improvement
Improvement in rVCSS
- 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% 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
Publications