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

  • Demonstrated efficacy and safety in
    first-in-human trial

  • FDA Breakthrough Device Designation

  • First device to receive IDE approval from the
    FDA for the treatment of deep venous CVI

Product
Highlights

  • Demonstrated efficacy and safety in
    first-in-human trial

  • FDA Breakthrough Device Designation

  • First device to receive IDE approval from the
    FDA for the treatment of deep venous CVI

Positive First-In-Human Clinical Study

In a first-in-human (FIH) clinical study, the VenoValve was evaluated in eleven patients with severe CVI. In addition to monitoring safety, the FIH study was designed with the same efficacy endpoints (reflux, VCSS score, VAS score, VEINS Quality of life score) being used in the ongoing SAVVE pivotal study.

The VenoValve had no device-related safety issues during the FIH study and all efficacy endpoints, reflux, CVSS and VAS, demonstrated a significant improvement following implantation of the device. All patients experienced statistically significant improvements in the quality of their lives, by a measure of VEINES Qol scores. In patients with active venous ulcers, there was dramatic ulcer healing with no ulcer recurrence.

Improvement is Maintained for 2.5 Years Without Adverse Events1

1.  No device related adverse events. Safety issues in first year included 1 seroma (which was aspirated), 3 minor wound infections, 1 over anticoagulation and 1 occlusion due to patient non-compliance. No device-related issues reported between months 12 and 30; one reported case of contralateral ulcer development.
2.  One-year results for 11 patients compared to Pre-VenoValve® implantation. 30-moth results for 8 patients compared to Pre-VenoValve® implantation

Venous Ulcer Healing

Although the study results were very encouraging, there is no guarantee that you will have the same or similar results, that your CVI will improve, and that your condition(s) will not worsen.

Implantation Procedure

Chronic Venous Insufficiency

Scientific Publications
and Presentations

SAVVE Clinical Study

The VenoValve® and enVVe™ are investigational medical devices currently 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.