For those publications discussing use of Galatea surgical scaffolds (GalaFLEX®, GalaSHAPE® 3D or GalaFORM® 3D), the FDA does not consider the use of these products as described in the publications to be within the cleared indications for use for each device. Significant safety risks or safety concerns associated with the use of Galatea scaffolds known to the manufacturer are described in the Instructions for Use for each of those devices.  

Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair

Category: Pre-Clinical
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Jeffrey R. Scott,Corey R. Deeken,Robert G. Martindale,Michael J. Rosen
Surgical Endoscopy
30(9):3691–3701.2016

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/27369286

ABSTRACT

Background:

The objective of this study was to evaluate the mechanical and histological properties of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh (Phasix™ ST) compared to partially absorbable (Ventralight™ ST), fully absorbable (Phasix™), and biologically derived (Strattice™) meshes in a porcine model of ventral hernia repair.

Methods:

Bilateral abdominal surgical defects were created in twenty-four Yucatan pigs, repaired with intraperitoneal (Phasix™ ST, Ventralight™ ST) or retromuscular (Phasix™, Strattice™) mesh, and evaluated at 12 and 24 weeks (n = 6 mesh/group/time point).

Results:

Prior to implantation, Strattice™ demonstrated significantly higher (p < 0.001) strength (636.6 ± 192.1 N) compared to Ventralight™ ST (324.3 ± 37.1 N), Phasix™ ST (206.9 ± 11.3 N), and Phasix™ (200.6 ± 25.2 N). At 12 and 24 weeks, mesh/repair strength was significantly greater than NAW (p < 0.01 in all cases), and no significant changes in strength were observed for any meshes between 12 and 24 weeks (p > 0.05). Phasix™ mesh/repair strength was significantly greater than Strattice™ (p < 0.001) at 12 and 24 weeks, and Ventralight™ ST mesh/repair strength was significantly greater than Phasix™ ST mesh (p < 0.05) at 24 weeks. At 12 and 24 weeks, Phasix™ ST and Ventralight™ ST were associated with mild inflammation and minimal–mild fibrosis/neovascularization, with no significant differences between groups. At both time points, Phasix™ was associated with minimal–mild inflammation/fibrosis and mild neovascularization. Strattice™ was associated with minimal inflammation/fibrosis, with minimal neovascularization at 12 weeks, which increased to mild by 24 weeks. Strattice™ exhibited significantly less neovascularization than Phasix™ at 12 weeks and significantly greater inflammation at 24 weeks due to remodeling.

Conclusions:

Phasix™ ST demonstrated mechanical and histological properties comparable to partially absorbable (Ventralight™ ST) and fully resorbable (Phasix™) meshes at 12 and 24 weeks in this model. Data also suggest that fully absorbable meshes with longer-term resorption profiles may provide improved mechanical and histological properties compared to biologically derived scaffolds.

Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications

Category: Pre-Clinical
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David P. Martin, PhD; Amit Badhwar, PhD; Devang V. Shah, PhD; Said Rizik, MS; Stephen N. Eldridge, MS; Darcy H. Gagne, BS; Amit Ganatra, MS; Roger E. Darois, BEng; Simon F. Williams, PhD; Hsin-Chien Tai, PhD; and Jeffrey R. Scott, PhD

Journal of Surgical Research 184(2):766-773.2013

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/23582230

ABSTRACT

Background: Phasix mesh is a fully resorbable implant for soft tissue reconstruction made from knitted poly-4-hydroxybutyrate monofilament fibers. The objectives of this study were to characterize the in vitro and in vivo mechanical and resorption properties of Phasix mesh over time, and to assess the functional performance in a porcine model of abdominal hernia repair.

Materials and Methods: We evaluated accelerated in vitro degradation of Phasix mesh in 3 mol/L HCl through 120 h incubation. We also evaluated functional performance after repair of a surgically created abdominal hernia defect in a porcine model through 72 wk. Mechanical and molecular weight (MW) properties were fully characterized in both studies over time.

Results: Phasix mesh demonstrated a significant reduction in mechanical strength and MW over 120 h in the accelerated degradation in vitro test. In vivo, the Phasix mesh repair demonstrated 80%, 65%, 58%, 37%, and 18% greater strength, compared with native abdominal wall at 8, 16, 32, and 48 wk post-implantation, respectively, and comparable repair strength at 72 wk post-implantation despite a significant reduction in mesh MW over time.

Conclusions: Both in vitro and in vivo data suggest that Phasix mesh provides a durable scaffold for mechanical reinforcement of soft tissue. Furthermore, a Phasix mesh surgical defect repair in a large animal model demonstrated successful transfer of load bearing from the mesh to the repaired abdominal wall, thereby successfully returning the mechanical properties of repaired host tissue to its native state over an extended time period.

DISCLOSURES

Dr. Simon Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr. David Martin is the Chief Scientific Officer of Tepha, Inc. Said Rizik, MS, Amit Ganatra, MS, Jeffrey R. Scott, PhD are employees of Tepha, Inc.

Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate—PHASIX Mesh) in a Porcine Model of Hernia Repair

Category: Pre-Clinical
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Corey R. Deeken, PhD and Brent D. Matthews, MD

ISRN Surgery 2013

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/23781348

ABSTRACT

Purpose: Poly-4-hydroxybutyrate (P4HB) is a naturally derived, absorbable polymer. P4HB has been manufactured into PHASIX Mesh and P4HB Plug designs for soft tissue repair. The objective of this study was to evaluate mechanical strength, resorption properties, and histologic characteristics in a porcine model.

Methods: Bilateral defects were created in the abdominal wall of n = 20 Yucatan minipigs and repaired in a bridged fashion with PHASIX Mesh or P4HB Plug fixated with SorbaFix or permanent suture, respectively. Mechanical strength, resorption properties, and histologic characteristics were evaluated at 6, 12, 26, and 52 weeks (n = 5 each).

Results: PHASIX Mesh and P4HB Plug repairs exhibited similar burst strength, stiffness, and molecular weight at all time points, with no significant differences detected between the two devices (P > 0.05). PHASIX Mesh and P4HB Plug repairs also demonstrated significantly greater burst strength and stiffness than native abdominal wall at all time points (P < 0.05), and material resorption increased significantly over time (P < 0.001). Inflammatory infiltrates were mononuclear, and both devices exhibited mild to moderate granulation tissue/vascularization.

Conclusions: PHASIX Mesh and P4HB Plug demonstrated significant mechanical strength compared to native abdominal wall, despite significant material resorption over time. Histological assessment revealed a comparable mild inflammatory response and mild to moderate granulation tissue/vascularization.

Indications for Use

GalaFLEX, GalaSHAPE 3D and GalaFORM 3D (Galatea scaffolds) are 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. Galatea 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 Information

Possible complications following implantation of Galatea scaffold include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. The safety and product use of Galatea scaffold for patients with hypersensitivities to the antibiotics kanamycin sulfate and tetracycline hydrochloride is unknown. Galatea scaffolds have not been studied for use in breast reconstructive surgeries. The safety and effectiveness of Galatea scaffold in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffold in pediatric use has not been established. Consult the Galatea scaffold Instructions for Use for complete prescribing information; including its indications for use, warnings and precautions.