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
Preliminary 11 Month Efficacy Data
Preliminary 11 Month Efficacy Data
Clinical Meaningful Benefit Cohorts
Clinical Meaningful Benefit Cohorts
Clinical Meaningful Benefit Cohorts
Clinical Meaningful Benefit Cohorts
rVCSS Cohorts Subanalyses
rVCSS Cohorts Subanalyses
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
Setting New Standards for Venous Care
The VenoValve® is a first-in-class surgically implanted solution being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). Implanted into the femoral vein, the VenoValve is designed to act as a one-way valve to help restore proper blood flow up the leg, to return sufficient blood back to the heart. The VenoValve is currently being evaluated in the SAVVE® pivotal study.
Product
Highlights
-
FDA Breakthrough Device Designation
-
First device to receive IDE approval from the
FDA for the treatment of deep venous CVI
Product
Highlights
-
FDA Breakthrough Device Designation
-
First device to receive IDE approval from the
FDA for the treatment of deep venous CVI
Patient Experience From Pivotal SAVVE® Study
Interviews from the 50th Annual VEITH Symposium
Initial Topline Results from SAVVE® U.S. Pivotal Trial
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.
Implantation Procedure
Chronic Venous Insufficiency
Scientific Publications
and Presentations