OVITEX

THE SCIENCE OF OVITEX

A MORE NATURAL HERNIA REPAIR™

OviTex, a Reinforced Tissue Matrix, was designed in collaboration with surgeons and healthcare providers to address the unmet clinical and financial needs in hernia repair and abdominal wall reconstruction. Our solutions are comprised of polymer fiber interwoven through layers of biologic material in a “lockstitch” pattern, which creates a unique embroidered construction, offering a technology designed to surpass the performance of all existing hernia repair and abdominal wall reconstruction mesh products.

The biologic material in OviTex, derived from ovine rumen, serves as the natural building block and is optimized to reduce foreign body response, enable functional tissue remodeling and promote a more natural hernia repair. The interwoven polymer fibers provide additional reinforcement, along with improved handling and load-sharing capability to support natural abdominal wall function. The polymer fiber is available in resorbable or permanent variations and comprises less than 5% of the final product*.

OviTex Reinforced Tissue Matrix combines the benefits of biologic material and polymer reinforcement to provide a more natural hernia repair when compared to mesh products made only of synthetic polymer material.

WATCH THE VIDEO TO LEARN MORE ABOUT THE DESIGN AND FUNCTIONALITY OF OVITEX

 

OVITEX CLINICAL EXPERIENCE

INNOVATIVE TECHNOLOGY BACKED BY EXTENSIVE PRECLINICAL TESTING AND AN ONGOING POST-MARKET CLINICAL STUDY EVALUATING SURGICAL OUTCOMES

Building on extensive preclinical testing in a non-human primate model, TELA Bio is committed to evidence-based medicine and investing in clinical data collection. Following thousands of implantations, surgeons have acknowledged OviTex as an innovative solution in hernia repair and abdominal wall reconstruction. Additionally, our ongoing prospective, single arm, multicenter post-market clinical study (the BRAVO* study) evaluating OviTex performance in ventral hernia repair is providing positive results.

*BRAVO: BioScaffold Reconstruction of Abdominal wall and Ventral hernia defects with Open or laparoscopic repair.

EARLY BRAVO STUDY RESULTS1

Analysis of the first 32 patients who reached 1-year follow-up demonstrated:

  • No device failures requiring follow-up surgery
  • No explantations
  • No ventral hernia recurrences

Reference:

  1. DeNoto G, et al. Reinforced Biologic reduces risk of recurrence in ventral hernia (VH) patients: One-year data from the BRAVO Ventral Hernia Study. Presented at: 11th Annual Abdominal Wall Reconstruction 2019 Conference. June 6-8, 2019; Washington, DC.

For additional clinical information about OviTex, contact us.

 

OVITEX PRS

AN ADVANCEMENT IN BIOLOGIC MATERIALS FOR PLASTIC AND RECONSTRUCTIVE SURGERY

OviTex PRS, our latest Reinforced Tissue Matrix, was purposefully designed to address the unmet clinical and financial needs of soft tissue repair in plastic and reconstructive surgery. Using the same natural building block as OviTex, OviTex PRS is comprised of three layers of ovine rumen interwoven with either permanent or resorbable polymer fibers using our patented “corner-lock” diamond embroidery construction.

The layers of biologic material have been innovatively designed to include a series of micropores, macropores and stents to facilitate better fluid management, tissue integration and directional flexibility of the product.

WATCH THE VIDEO TO LEARN MORE ABOUT THE DESIGN AND FUNCTIONALITY OF OVITEX PRS

 

THE OVITEX PORTFOLIO OF PRODUCTS

Our comprehensive portfolio of solutions offers four configurations of OviTex specifically designed for hernia repair and abdominal wall reconstruction and one for plastic and reconstructive surgery.

These solutions, comprised of over 95% biologic material*, are available with either permanent (polypropylene) polymer or resorbable (polyglycolic acid) polymer reinforcing the same biologic material.

  • OviTex

    Instructions for Use: Permanent

    Instructions for Use: Resorbable

    • 4-layer device, not intended for intraperitoneal placement
    • STRENGTH: +
    • VISCERA CONTACT§: Not recommended
  • OVITEX SKU INFORMATION
    FamilySize (cm)PermanentResorbable
    OviTex4 x 8F10244-0408PF10254-0408G
    OviTex6 x 10F10244-0610PF10254-0610G
    OviTex10 x 12F10244-1012PF10254-1012G
    OviTex10 x 20F10244-1020P
    OviTex16 x 20F10244-1620P
    OviTex20 x 20F10244-2020PF10254-2020G
    OviTex25 x 30F10244-2530P
    OviTex25 x 40F10244-2540P
  • OviTex 1S

    Instructions for Use: Permanent

    Instructions for Use: Resorbable

    • 6-layer device, with "smooth external layers" suitable for intraperitoneal placement
    • STRENGTH: + +
    • VISCERA CONTACT§: Yes
  • OVITEX 1S SKU INFORMATION
    FamilySize (cm)PermanentResorbable
    OviTex 1S4 x 8F10246-0408PF10256-0408G
    OviTex 1S6 x 10F10246-0610PF10256-0610G
    OviTex 1S10 x 12F10246-1012PF10256-1012G
    OviTex 1S10 x 20F10246-1020PF10256-1020G
    OviTex 1S16 x 20F10246-1620PF10256-1620G
    OviTex 1S18 x 22F10246-1822P
    OviTex 1S20 x 20F10246-2020PF10256-2020G
    OviTex 1S25 x 30F10246-2530P
    OviTex 1S25 x 40F10246-2540P
  • OviTex 2S

    Instructions for Use: Permanent

    Instructions for Use: Resorbable

    • 8-layer device, with 2 "smooth external layers" suitable for intraperitoneal placement
    • STRENGTH: + + +
    • VISCERA CONTACT§: Yes
  • OVITEX 2S SKU INFORMATION
    FamilySize (cm)PermanentResorbable
    OviTex 2S10 x 12F10248-1012P
    OviTex 2S10 x 20F10248-1020PF10258-1020G
    OviTex 2S16 x 20F10248-1620PF10258-1620G
    OviTex 2S18 x 22F10248-1822P
    OviTex 2S20 x 20F10248-2020PF10258-2020G
    OviTex 2S25 x 30F10248-2530P
    OviTex 2S25 x 40F10248-2540P
  • OviTex LPR

    Instructions for Use: Permanent

    • 4-layer device, with "smooth side" suitable for laparoscopic and robotic-assisted intraperitoneal placement
    • STRENGTH: +
    • VISCERA CONTACT§: Yes
  • OVITEX LPR SKU INFORMATION
    FamilySize (cm)Permanent
    OviTex LPR12 x 18F10244-1218L
  • OviTex PRS

    Instructions for Use: Permanent

    Instructions for Use: Resorbable

    • 3-layer device, available in 4 shapes for plastic and reconstuctive surgery
  • OVITEX PRS SKU INFORMATION
    FamilySize (cm)ShapePermanentResorbable
    OviTex PRS16 x 22Oval PortraitR30353-1622G
    OviTex PRS16 x 22Oval LandscapeR20353-1622G
    OviTex PRS8 x 15ContourR20243-0815PR20253-0815G
    OviTex PRS7 x 17ContourR20253-0717G
    OviTex PRS10 x 18.5ContourR20243-1018PR20253-1018G
    OviTex PRS10.5 x 20ContourR20253-1020G
    OviTex PRS11.5 x 22ContourR20243-1122PR20253-1122G
    OviTex PRS4 x 16RectangleR20143-0416PR20153-0416G
    OviTex PRS8 x 20RectangleR20143-0820PR20153-0820G
    OviTex PRS16 x 20RectangleR20143-1620PR20153-1620G
    OviTex PRS20 x 20RectangleR20143-2020PR20153-2020G
  • * Biologic percentage calculated by weight after rehydration.
  • OviTex, OviTex 1S and OviTex 2S sizes 25x30cm and 25x40cm available with permanent polymer only. OviTex LPR available with permanent polymer only.
  • Biomechanical data on file.
  • §OviTex 1S and OviTex 2S were shown not to adhere in an animal model - data on file. Correlation to results in humans has not been established.

OviTex and OviTex 1S images represent permanent polymer products. OviTex PRS image represents permanent and resorbable polymer products.

Products may not be available in all countries because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your TELA Bio representative if you have questions about TELA Bio products.

OviTex Reinforced Tissue Matrix may be referred to as OviTex Reinforced BioScaffold.
OvITex PRS Reinforced Tissue Matrix may be referred to as Restella Reconstructive BioScaffold.

For additional product information, click here.

 

COST EFFICIENCY WITH OVITEX

CREATING VALUE FOR YOUR INSTITUTION

With consistent clinical results and competitive pricing compared to market-leading biologic and resorbable synthetic meshes, OviTex represents a new product category that truly addresses clinical and financial concerns regarding hernia repair implants. Our flexible financial models allow us to deliver significant cost savings to providers across a variety of health care settings, and we would appreciate the opportunity to prove this to your organization.

ACHIEVE IMMEDIATE COST SAVINGS WITH OVITEX

  • 20% TO 40% REALIZED COST SAVINGS

    Across multiple health care settings, OviTex results in substantial savings over leading biologics and resorbable synthetics

  • DISCOUNTED LINE-ITEM PRICING

    Provides immediate cost savings of 15% to 25% with no committed usage volume

  • COMMITTED VOLUME PRICING

    Delivers savings of more than 25% with nominal unit or dollar volume commitment*

To find out how OviTex can reduce your hernia repair cost, request a cost analysis.

*Average savings may vary by account.

REIMBURSEMENT GUIDE

Get the reimbursement information you need for hernia repair procedures using OviTex.

EU manufacturing and representation:

Manufactured by: Aroa Biosurgery, Ltd.
2 Kingsford Smith Place,
Airport Oaks, Auckland 2022, New Zealand

Authorized Representative in the European Community:
HealthLink Europe Services BV. De Tweeling 20-22,
5215 MC ‘s-Hertogenbosch, The Netherlands