Surgical Anti-reflux Venous Valve Endoprosthesis

Ongoing Pivotal Study to Evaluate VenoValve® for the Treatment of Chronic Venous Insufficiency

About the trial

What is the
SAVVE study?

Chronic Venous Insufficiency (CVI) occurs when the valves inside the veins of your leg do not function properly, causing blood to flow backwards and pool in the lower leg, leading to elevated venous pressure inside the leg veins.

The purpose of the SAVVE study is to determine whether the VenoValve is a safe and effective treatment for patients with severe, deep venous CVI.

 

What is the

VenoValve

procedure?

The VenoValve is surgically implanted into a vein via a 5-to-6 inch incision in the upper thigh. The procedure should take less than an hour and the patient will receive general or regional anesthesia.

After the VenoValve procedure, the patient will stay in the hospital for one night for patient comfort.

 

How long is the
SAVVE study?

The patient will be asked to see their doctor 7 days, 30 days, 90 days, 180 days, and 365 days after the VenoValve procedure. The VenoValve is designed to be a permanent implant and the patient should continue to see their doctor once a year for at least the next 4 years.

 

What is VenoValve

What is the VenoValve Procedure?

 

Am I the first patient to receive the VenoValve?

 

Positive first-in-human results

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 Events

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.

Am I eligible for the study?

 

Patients with severe CVI who experience symptoms including leg swelling, discoloration, heaviness, itchiness, pain, and open sores that are difficult to heal, may be candidates for the SAVVE study. Please contact us to determine if you qualify for the SAVVE study.

Male and Female

Adult Patients

Chronic, axial deep
venous reflux secondary
to previous deep venous thrombosis or primary reflux

Failed at least 3 months of standard care including compression therapy, and in C6 patients, wound care

Am I a Candidate to Participate in the SAVVE Study?

 

Active Sites

Albany Medical Center
391 Myrtle Ave,
Albany, NY 12208
PI Name: Dr. Adriana Laser
Primary Contact: Stephanie Collins

Cedars-Sinai Medical Center
La Cienega Blvd.
Beverly Hills, CA 90211
PI Name: Dr. NavYash Gupta
Primary Contact: Goran Stankovic

Englewood Health
350 Engle St.
Englewood, NJ 07631
PI Name: Dr. Steven Elias
Primary Contact: Nathalia Clark

Henry Ford Health System
2799 West Grand Blvd.
Detroit, MI 48202
PI Name: Dr. Paul Corcoran
Primary Contact: Winnie Cheung

Indiana University
1801 North Senate Blvd., D3500
Indianapolis, IN 46202
PI Name: Dr. Raghu Motaganahalli
Primary Contact: Vickie Olsen

Jobst Vascular Institute /
Promedica Toledo Hospital

2109 Hughes Drive, CJT STE. 400
Toledo, OH 43606
PI Name: Dr. Gregory Kasper
Primary Contact: Lynn Kenney

Kaleidahealth/University at Buffalo
100 High St.
Buffalo, NY 14203
PI Name: Dr. Linda Harris
Primary Contact: Robin Stein

Miami Vascular Specialists
8950 N. Kendall Drive
Miami, FL 33176
PI Name: Dr. Michele Taubman
Primary Contact: Ivette Cruz

NYU Langone
530 1st Ave, HCC6F
New York, NY 10016
PI Name: Dr. Mikel Sadek
Primary Contact: Jacqueline Bott

Pima Heart and Vascular
3709 N. Campbell, STE. 135
Tucson, AZ 85719
PI Name: Dr. Scott S Berman
Primary Contact: Aleksander Herber

Saint Louis University
1008 S Spring Ave.
Saint Louis, MO 63110
PI Name: Dr. Matthew Smeds
Primary Contact: Craig Dedert, RN

Sentara
600 Gresham Drive
Norfolk, VA 23507
PI Name: Dr. David Dexter
Primary Contact: Sarah Havert

Stony Brook Medicine
101 Nicolls Rd.
Stony Brook, NY 11794
PI Name: Dr. Antonios Gasparis
Primary Contact: Andrew Bryan

TriHealth
375 Dixmyth Avenue
Cincinnati, OH 45220
PI Name: Dr. Patrick Muck
Primary Contact: Faizan Qureshi

University of Alabama at Birmingham
Vascular Surgery and Endovascular Therapy
BDB 652, 1808 7th Ave. South
Birmingham, AL 35294
PI Name: Dr. Marc Passman
Primary Contact: Rebecca St. John

University of Chicago
5841 S. Maryland Ave., MC 5028
Chicago, IL 60637
PI Name: Dr. Chelsea Dorsey
Primary Contact: MacKenton Johnson

University Hospitals Cleveland
Medical Center
11100 Euclid Ave.
Cleveland, OH 44106
PI Name: Dr. Karem Harth
Primary Contact: Emily Mullenax

University of North Carolina
3024 Burnett-Womack Bldg
Chapel Hill, NC 27516
PI Name: Dr. William Marston
Primary Contact: Zachary Gortler

UPMC
5200 Centre Avenue
Pittsburgh, PA 15232
PI Name: Dr. Rabih Chaer
Primary Contact: Julianna Sheline

University of Utah
30 N. 1900 East, Room 3C344 SOM
Salt Lake City, UT 84132
PI Name: Dr. Claire L. Griffin
Primary Contact: Maria Maloney

Vanderbilt University Medical Center
D-5237 Med Center North,
1161 21st Ave. South
Nashville, TN 37232
PI Name: Dr. Mark Iafrati
Primary Contact: Celia Nunez

Yale New Haven Hospital
330 Cedar St, Boardman 204
New Haven, CT 06510
PI Name: Dr. Cassius Iyad Ochoa Chaar
Primary Contact: Patrice Lauture

Future Sites

Coastal Vascular Institute
7720 US 98 West, Suite 240
Destin, FL 32550
PI Name: Dr. Geoffrey Risley
Primary Contact: Kelly Stewart

Houston Methodist Hospital
6550 Fannin St.
Houston, TX 77030
PI Name: Dr. Eric Peden
Primary Contact: Kim Donlon, RN

Active Sites    Future Sites

Who are the Principal Investigators?

 

Are you a treating physician and have a potential candidate for the SAVVE study?

 

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