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.
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
*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.
OviTex® Reinforced Tissue Matrix
OviTex Reinforced Tissue Matrix (RTM) is a next generation soft tissue repair platform that utilizes layers of ovine (sheep) rumen interwoven with just enough polymer suture for added strength. This combination results in a very low polymer load (areal density) that is less than lightweight mesh. By having a low polymer load, OviTex effectively reduces the amount of plastic placed in the body.1*
All OviTex RTM devices are designed to leverage a patient’s natural healing response, facilitate tissue remodeling, optimize strength, and minimize the foreign body footprint of synthetic polymer.
Indications for Use
OviTex is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.
Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcomes.
A Reinforced Biologic For Hernia Repair And Abdominal Wall Reconstruction
A More Natural Hernia Repair®.
Consistently Low Recurrence Rates.
Strong & More Natural Construct
Strong construct provides support across the fascia while also providing a matrix that encourages rapid granulation leading to tissue remodeling. The high tensile strength with low elastin content minimizes stretching (matching compliance of the abdominal wall) and makes OviTex effective for placement under tension.5
Just Enough Reinforcement Material
The low amount of interwoven polymer holds the biologic layers together while providing strength, structure and improved handling. The polymer also provides additional reinforcement during the early healing phase.5
Rapid Integration And Remodeling
Pores allow for fluid transfer (permeability); the embroidered construction creates hundreds of pores to the already highly porous ECM, allowing for fluid transfer through the device. High rates of permeability and fluid transfer complement the use of negative pressure wound therapy.
Assists In Complex Environments
OviTex retains its integrity and has shown resilience in cases of complex surgical repairs.4 The use of OviTex RTM assists in delivering an effective and durable fascial repair.6, 7
OviTex® Reinforced Tissue Matrix
Lower Recurrence Rates
Than Other Leading Hernia Devices*
Approach
Approach
Approach
Placement
Placement
Placement
Placement
Placement
Placement
Placement
Seperation
Complications
Complications
(Final Follow-Up Population)
(Kaplan Meier estimate)
PERMANENT
Tissue Matrix
matrix and
polypropylene
(46%)
Pre-Peritoneal
(1.1%)
(including SSI)
(3/66)
Synthetic
hydroxybutyrate
(P4HB)
Synthetic
(P4HB) with a
hydrogel barrier
(required intervention)
(25/63)
Synthetic
hydrogel barrier or
polypropylene
(30%)
(excluding SSI)
(14/64)
*(18.6% defects < 7.1 cm2 and 43.3% defects > 7.1 cm2)a
**No head-to-head clinical studies have been conducted. Due to differences in patient population, surgeons, surgical technique, and other variables, direct comparisons of results must be made with caution. For a comparative discussion of these studies, please see G. DeNoto, E.P. Ceppa, S.J. Pacella, M. Sawyer, G. Slayden, M. Takata, G. Tuma, J. Yunis, 24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex® 1S permanent reinforced tissue matrix, Ann Medicine Surg 2022, 83.
Four Configurations. From Open to Robotic,
The Right Solution At The Right Time.
Our comprehensive portfolio of solutions offers four configurations of OviTex specifically designed for hernia repair and abdominal wall reconstruction applications. Each device has its own unique features to ensure you have the right solution at the right time.
OviTex Core
4-layer device
No smooth sides
Thickness: ~0.9 mm
OviTex Core is designed to reinforce primary hernia repairs where the device
will not come into contact
with bowel.
Areas of use example(s):
- Retrorectus repair
- Onlay repair
OviTex 1s
6-layer device
1 smooth side
Thickness: ~1.1 mm
OviTex 1S incorporates a smooth side that is designed to minimize tissue attachment
and to reinforce primary hernia repairs where the device may come into contact with bowel (e.g. intraperitoneal).
Areas of use example(s):
- Most hernia repairs
OviTex 2s
8-layer device
2 smooth sides
Thickness: ~1.6 mm
OviTex 2S incorporates eight layers of tissue for added strength. The two smooth sides make it suitable for intraperitoneal placement.
Areas of use example(s):
- Sugarbaker repair
- Bridging repair
- Large loss of tissue repair
OviTex LPR*
4-layer device
1 smooth side
Thickness: ~0.9 mm
OviTex LPR is designed specifically for use in laparoscopic and robotic hernia repair procedures. The design also incorporates a smooth side making it suitable for intraperitoneal placement.
Areas of use example(s):
- Most robotic and laparoscopic repairs
4 layers
4 layers
(25 mm Grid) 6 layers
(25 mm Grid) 6 layers
(25 mm Grid) 8 layers
(25 mm Grid) 8 layers
4 layers
4 layers
Permanent Reinforcement: All suture is 5-0 Polypropylene (PP) – blue and clear
Resorbable Reinforcement: All suture is 6-0 Polyglycolic Acid (PGA) – clear only