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.

(clinicaltrials.gov/NCT03074474)

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.

End Points & 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

Demographic

FEMALE   55 (55.78%)

MALE   37 (40.22%)

AGE   60.4 (+/- 13.1 years)

BMI   31.0 (+/- 4.5) kg/m2

OBESITY   51 (55.43%)

DIABETES   20 (21.74%)

AT LEAST
1 RISK
FACTOR*   72
(78.26%)

Wound Classification

CDC CLASS I   74 (80.43%)

CDC CLASS II   14 (15.22%)

CDC CLASS III   4 (4.35%)

mVHWG GRADE I   21 (22.83%)

mVHWG GRADE II   52 (56.52%)

mVHWG GRADE III   19 (20.65%)

Surgical History

PRIOR VENTRAL
HERNIA REPAIRS   34
(36.96%)

AVG# PRIOR
VH REPAIRS   1.9 (+/- 0.97%)

Safety Results

SSO
HERNIA RECURRENCE
Overall %
38.0%
2.6%*

*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

7+ Years

Clinical Experience

Implantations Globally*

Years of Clinical Experience

Published or Presented Works

Surgeon Users Globally*

*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.