The SAVVE^® surgical procedure

Specifically designed by vascular surgeons for vascular surgeons

See the SAVVE surgical procedure in action

The SAVVE procedure to implant the VenoValve is an open surgical procedure performed in an operating room setting on an outpatient basis, utilizing skills and techniques that are familiar to the vascular surgeon, for consistent and reproducible results.

SAVVE surgical procedure step-by-step

The SAVVE procedure will seamlessly fit into the existing venous clinical workflow, to establish itself as the new treatment paradigm for deep venous insufficiency.

1. Patient positioning

Patient supine, frog-leg position, bump under knee
Identify target vein location with duplex scan

2. Surgical incision

6-inch incision
Along lateral border of sarturius
Extend length as needed

3. Vessel exposure

Dissect femoral artery/vein
Ligate bleeders and lymph channels
Mobilize femoral vein for at least 6cm
Ensure patient is heparinized
Place clamps on proximal and distal ends of vein

4. Venotomy

1.5cm incision in the vein; use two stay sutures to open
Treat vein spasm as needed

5. VenoValve sizing

Use duplex and direct vein exam after mobilization
Select device size (see sizing table)

6. VenoValve preparation

Remove from container using forceps; handle via tag or rings
Remove tag
Place valve in sterile saline

7. VenoValve placement

Orient arrow pointing to foot, sinus facing up
Place using manual manipulation
Ensure it covers the venotomy site

8. Secure VenoValve

Flush vein, check for clots
Close vein with running 6-0 or 5-0 prolene suture
Secure inflow/caudal rings to vein wall with 4+ evenly-spaced sutures

9. Assess and close

Release clamps, check for bleeding
Assess patency and reflux with duplex or CW Doppler
Meticulous closure

Learn more about VenoValve

Who is the right patient for the SAVVE surgical procedure?

The first and only FDA approved safe and effective treatment for severe (C4b to C6) deep Chronic Venous Insufficiency (CVI) of the lower extremity caused by valvular incompetency.

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THE KEYS TO IDENTIFYING THE APPROPRIATE VENOVALVE PATIENT

C4b-C6

Primary or post-thrombotic

Femoral vein

Femoral vein reflux with limited obstruction

The VenoValve: unique structural components

The VenoValve utilizes the non-coronary native leaflet from a porcine heart valve, as a single, pre-formed venous valve leaflet with a unique mono-cusp design. The valve is hand-sutured to a specially shaped stainless-steel frame, with each component of the replacement venous valve, including the supporting wall, carefully selected and engineered to provide optimal hemodynamics, minimizing flow disturbances and reducing the risk of thrombus formation.