Now in 3D! The only contoured scaffold for plastic surgery designed to fit the body’s natural shape, provide easier placement and reduce procedure time.

Naturally Contoured. Embracing the Curve.

3-Dimensional

Biologically Derived

Monofilament

Strong

Bioresorbable

Galatea Surgical, Inc. 99 Hayden Avenue, Suite 360 Lexington, MA 02421

Phone: (781) 357-1750Fax: (877) 357-0484 Email: Contact@GalateaSurgical.comwww.galateasurgical.com

1. Data on file at Tepha. Similar studies in humans have not been performed.

2. Martin, David P., et al. “Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research 184.2 (2013): 766-773.

3. Wolloscheck, T., et al. “Inguinal hernia: measurement of the biomechanics of the lower abdominal wall and the inguinal canal.” Hernia 8.3 (2004): 233-241.

Galatea Surgical, Inc. is a wholly owned Subsidiary of Tepha, Inc. Galatea Surgical © 2017. All Rights Reserved. 500029 Rev D

Shape Product Code# per

PackageSize (cm) Size (in)

SH3D01 15.3 x 15.5 2.1 x 6.1

SH3D02 2

SH3D03 16.4 x 18.5 2.5 x 7.3

SH3D04 2

SH3D05 17.5 x 21.0 3.0 x 8.3

SH3D06 2

SH3D07 17.6 x 20.3 3 x 8

SH3D08 2

SH3D09 12.5 x 7.6 1 x 3

SH3D10 2

SH3D11 12.5 x 10.2 1 x 4

SH3D12 2

SH3D13 17.6 3

SH3D14 2

GalaFLEX GalaSHAPEGalaFLEX GalaSHAPE

GalaFLEX GalaSHAPE

GalaFLEX GalaSHAPE GalaFORM

GalaFLEX GalaSHAPE

GalaSHAPE 3D: Available Sizes & Shapes

Oval

Rectangular

Rectangular

Triangular

Circular

GalaSHAPE 3D scaffold is the only 3-dimensional shaped scaffold for plastic and reconstructive surgery that supports, elevates, repairs and reinforces soft tissue. This unique 3D monofilament scaffold is made from the biologically derived poly-4-hydroxybutyrate (P4HB), which naturally bioresorbs through hydrolysis.

• Contoured design is easier to insert and suture in place, while reducing procedure time.

• After implantation, the scaffold slowly bioresorbs while tissue grows into the lattice, resulting in tissue that is 3-5 times stronger than native tissue after 18-24 months when the scaffold is entirely bioresorbed.1,2,3

• Choose from a full portfolio of 3D shapes and sizes to complement the body’s natural shape.

Indications for UseGalaSHAPE 3D scaffold is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE 3D scaffold is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Important Safety ConsiderationsPossible complications include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. The safety and use of GalaSHAPE 3D for patients with hypersensitivities to the antibiotics kanamy-cin sulfate and tetracycline hydrochloride is unknown. Galatea scaffolds have not been studied for use in breast reconstructive surgeries. The safety and effectiveness of GalaSHAPE 3D scaffold in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of GalaSHAPE 3D scaffold in pediatric use has not been established.

Consult the GalaSHAPE 3D Instructions for Use for complete prescribing information, including its indications for use, warnings and precautions.

Shapes that fit right in.

The Galatea Collection of Scaffolds offers you a full portfolio of sizes and shapes for each patient’s surgical needs.