BioScaffold Reconstruction
of Abdominal wall and
Ventral hernia defects with
Open or laparoscopic repair
Investigators
George DeNoto IIISt. Francis Hospital, Rosyln, New York
Eugene P. CeppaIndiana University School of Medicine, Indianapolis, IN
Salvatore J. PacellaScripps Clinic and Scripps M.D. Anderson Cancer Center, San Diego, CA
Michael SawyerComanche County Memorial Hospital, Lawton, OK
Geoffrey SlaydenSt. Luke’s Surgical Specialists, St. Luke’s Health System, Overland Park, KS
Mark TakataScripps Clinic Medical Group, La Jolla, CA
Gary TumaCapital Health Medical Group, Pennington, NJ
Jonathan Yunis Center for Hernia Repair, Sarasota, FL
PROSPECTIVE, SINGLE-ARM,
MULTI-CENTER CLINICAL TRIAL
evaluating OviTex 1S Permanent
in patients undergoing
ventral hernia repair.
DESIGNED TO EVALUATE THE PERFORMANCE OF OVITEX
under real world conditions
which included open and minimally
invasive approaches as well as
different planes of placement.
92 PATIENTS WERE
ENROLLED AND TREATED
at seven (7) investigational sites throughout the United States.
Criteria
Inclusion
18 years or older with ≤ 40 kg/m2.
Ventral hernias requiring repair with an expected OviTex 1S matrix size no larger than 400cm2 (18 x 22cm, 20 x 20cm or less).
Patients had ventral hernias meeting the CDC wound classification system of Class I (Clean), Class II (Clean-Contaminated), or Class III (Contaminated).
Exclusion
Younger than 18 years.
Had a BMI above 40 kg/m2.
Had a ventral hernia expected to require a matrix larger than 400cm2.
Patients with CDC Class IV (Dirty-Infected) wounds, who were pregnant, had a life expectancy of <2 years, had a history of drug or alcohol abuse in the last 3 years, and/or were allergic to ovine-derived products were excluded.
Endpoints & Follow Up
Endpoints
Incidence of SSOs or wound related events at the hernia repair site including seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections.
Incidence of other complications (such as ileus and bowel obstruction) < 90 days after index surgery.
Incidence of hernia recurrence.
The EuroQol-5 Dimension (EQ-5D) health assessment and the validated 12-question Hernia-Related Quality of Life survey (HerQLes) were used to assess patient reported quality of life (QoL).
Follow Up
Patients were evaluated at 1, 3, 12, and 24-months.
At each follow up visit, patients underwent physical examination to assess post-operative adverse events, surgical complications, or hernia recurrence.
Patient reported outcome data was collected at each visit.
Patient Characteristics
*Includes obesity, advanced age ≥ 75 years, diabetes mellitus, coronary artery disease, active smoking and chronic obstructive pulmonary disease.
Safety Results
*Kaplan Meier estimated recurrence rate
Previously published favorable
results summarized below.
The utility of OviTex in ventral hernia repair is established by the previously published favorable results and by the prospective 24-month BRAVO results.
recurrence rate in the 24
month Bravo study is in line
with previously published
favorable results.
Recurrence Rate / Incidence of SSO
For Hernia Repair
6+ Years
Clinical Experience
Implantations*
Published or Presented Works*
Surgeon Users*
%
Recurrence rate at
24 Months1**
(BRAVO Study)
*TELA Bio sales data.
** OviTex demonstrated a 2.6% recurrence rate at 24 months in a 92-patient prospective, single arm, multi-center clinical trial with 65 patients at 24 months.
PURPOSEFULLY DESIGNED
To address the shortcomings of traditional synthetic and biologic mesh implants.
To minimize the foreign-body footprint to be a more natural alternative to permanent synthetic mesh.
To be applicable for all hernia indications and surgical approaches (open, laparoscopic, and robotic).
Layered Biologic
Layers of ovine (sheep) extracellular matrix provides a 3-D scaffold for rapid cellular infiltration and angiogenesis to enable functional tissue remodeling5
PERMEABLE DESIGN
Facilitates fluid transfer and movement of cells throughout the matrix.2
POLYMER REINFORCEMENT
Interwoven polymer suture for added strength and improved handling compared to non-embroidered construct. Lockstitch embroidery pattern creates ripstop effect and prevents unraveling when cut.