Biologically Derived

Monofi lament

Strong

Bioresorbable

Naturally Strong.Lasting Support.

A soft tissue support sca� old designed to achieve longer, more enduring results by promoting rapid tissue ingrowth and a stronger repair.

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

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

1 Data on fi le at Tepha, Inc.

Galatea Surgical, Inc. is a wholly owned Subsidiary of Tepha, Inc. Galatea Surgical © 2016. All Rights Reserved. 500031 Rev D

GalaFLEX sca� old is the only biologically derived sca� old for plastic and reconstructive surgery that is constructed from poly-4-hydroxybutyrate (P4HB), extruded into monofi lament fi bers and knitted into a strong, bioresorbable sca� old.

• Available in fl at sca� old shapes and designs. • Can be trimmed to the desired size without concern that

the monofi lament sca� old frays and causes irritation.• After implantation, the sca� old 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 sca� old is entirely bioresorbed.1

Indications for UseGalaFLEX sca� old is indicated for use as a bioresorbable sca� old for soft tissue support and to repair, elevate and reinforce defi ciencies 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. GalaFLEX sca� old 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, sca� old migration, wound dehiscence, hemorrhage, adhesions, hematoma, infl ammation, extrusion and recurrence of the soft tissue defect.

The safety and use of GalaFLEX for patients with hypersensitivities to the antibiotics kanamycin sulfate and tetracycline hydrochloride is unknown. Galatea sca� olds have not been studied for use in breast reconstructive surgeries. The safety and e� ectiveness of GalaFLEX sca� old in neural tissue and in cardiovascular tissue has not been established. The safety and e� ectiveness of GalaFLEX sca� old in pediatric use has not been established.

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

GalaFLEX: Available Sizes & Shapes

Shape Product Code Size (cm) Size (in)

GP0103 2.5 x 7.6 1 x 3

GP0206 5 x 15 2 x 6

GP0208 5 x 20 2 x 8

GP0408 10 x 20 4 x 8

GP0608 15 x 20 6 x 8

GP016S 22 x 10 8.6 x 4

GP016M 26 x 11.8 10 x 4.6

GP019S 14 x 7.7 5.5 x 3

GP019M 18 x 10 7 x 4

GP013S 22 x 9 8.6 x 3.5

GP013M 26 x 10.6 10 x 4

GP017S 22 x 8.5 8.6 x 3

GP017M 26 x 10.15 10 x 4

GP0104 2.5 x 10 1 x 4

GalaFLEX GalaSHAPEGalaFLEX GalaSHAPEGalaFLEX GalaSHAPEGalaFLEX GalaSHAPEGalaFLEX GalaSHAPE

GalaFLEX GalaSHAPE

The Galatea Collection of Sca� olds o� ers you a full portfolio of sizes and shapes for each patient’s surgical needs.