Below are abstracts and links to publications discussing the P4HB polymer. These publications do not constitute endorsement for use in any specific procedure.

For those publications discussing use of Galatea surgical scaffolds (GalaFLEX®, GalaFLEX 3D® or GalaFLEX 3DR®), 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.  

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up.

Category: Clinical
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John Scott Roth, Gary J. Anthone, Don J. Selzer, Benjamin K. Poulose, James G. Bittner, William W. Hope, Raymond M. Dunn, Robert G. Martindale, Matthew I. Goldblatt, David B. Earle, John. R. Romanelli, Gregory J. Mancini, Jacob A. Greenberg, John G. Linn, Eduardo Parra-Davila

Surgical Endoscopy 32(4):1929–1936.2018

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/29063307

ABSTRACT

 

BACKGROUND:

Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh.

METHODS:

This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing.

RESULTS:

One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively.

CONCLUSIONS:

High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

Ventral hernia repair with poly-4-hydroxybutyrate mesh.

Category: Clinical
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Margaret A. Plymale, Daniel L. Davenport, Adam Dugan, Amanda Zachem, John Scott Roth

Surgical Endoscopy 32(4):1689–1694.2018

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/28916979

ABSTRACT

BACKGROUND:

Biomaterial research has made available a biologically derived fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for use in ventral and incisional hernia repair (VIHR). This study evaluates outcomes of patients undergoing VIHR with P4HB mesh.

METHODS:

An IRB-approved prospective pilot study was conducted to assess clinical and quality of life (QOL) outcomes for patients undergoing VIHR with P4HB mesh. Perioperative characteristics were defined. Clinical outcomes, employment status, QOL using 12-item short form survey (SF-12), and pain assessments were followed for 24 months postoperatively.

RESULTS:

31 patients underwent VIHR with bioresorbable mesh via a Rives-Stoppa approach with retrorectus mesh placement. The median patient age was 52 years, median body mass index was 33 kg/m2, and just over half of the patients were female. Surgical site occurrences occurred in 19% of patients, most of which were seroma. Hernia recurrence rate was 0% (median follow-up = 414 days). Patients had significantly improved QOL at 24 months compared to baseline for SF-12 physical component summary and role emotional (p < 0.05).

CONCLUSIONS:

Ventral hernia repair with P4HB bioresorbable mesh results in favorable outcomes. Early hernia recurrence was not identified among the patient cohort. Quality of life improvements were noted at 24 months versus baseline for this cohort of patients with bioresorbable mesh. Use of P4HB mesh for ventral hernia repair was found to be feasible in this patient population. (ClinicalTrials.gov Identifier: NCT01863030).

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.

Poly-4-hydroxybutyrate (P4HB) in Biomedical Applications and Tissue Engineering

Category: Review
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Guo, Kai, Martin, David

Biodegradable Polymers 2(7):199-231.2015

Link to Publication: https://www.researchgate.net/publication/290183665_Poly-4-hydroxybutyrate_P4HB_in_Biomedical_Applications_and_Tissue_Engineering

ABSTRACT

Poly-4-hydroxybutyrate (P4HB) is a resorbable, thermoplastic homopolyester with a linear chain structure of 4-hydroxybutyrate monomers. High molecular weight P4HB is difficult to synthesize chemically but can be produced via a recombinant bacterial fermentation process through biologic catalysis using enzymes from the polyhydroxyalkanoate biosynthetic pathway. Due to its biocompatibility and biodegradability, as well as its unique mechanical properties, P4HB has emerged during the last decade as a promising biomaterial for various biomedical applications including tissue engineering (congenital heart defects, heart valves and vascular grafts), suture materials, and surgical textiles. In 2007, the TephaFLEX® absorbable monofilament suture was the first medical device derived from P4HB cleared for clinical use by the Food and Drug Administration (FDA) in the United States. Since then, additional regulatory clearances in the US and Europe have expanded the applications of P4HB products to include devices for hernia repair, tendon and ligament repair, and plastic and reconstructive surgery. This chapter will review the unique characteristics of P4HB polymer for use in resorbable medical evices, its processing into various forms, together with strategies that can be used to tailor the material properties for a variety of clinical applications. A number of exciting tissue engineering products based on P4HB that are currently in development, including vascular grafts and heart valves, will be presented as well as examples of potential future medical applications of P4HB in regenerative medicine.

DISCLOSURE:

 Dr. David Martin is the Chief Scientific Officer of Tepha, Inc. Kai Guo is an employee of Tepha, Inc.

Combination of Surgical Technique and Bioresorbable Mesh Reinforcement of the Crural Repair Leads to Low Early Hernia Recurrence Rates with Laparoscopic Paraesophageal Hernia Repair

Category: Clinical
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Walaa F. Abdelmoaty, Christy M. Dunst, Filippo Filicori, Ahmed M. Zihni, Daniel Davila-Bradley, Kevin M. Reavis

Lee L. Swanstrom, Steven R. DeMeester

Journal of Gastrointestinal Surgery 2019

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/31468330

Abstract

Introduction:

Laparoscopic paraesophageal hernia (PEH) is associated with a low morbidity and mortality but an objective hernia recurrence rate in excess of 50% at 5 years. Biologic mesh has not been shown to reduce hernia recurrence rates. Recently, a new bioresorbable mesh made with poly-4-hydroxybutyrate with a Sepra-Technology coating on one side (Phasix-ST mesh) has become available. The aim of this study was to evaluate the feasibility, safety, and short-term efficacy of Phasix-ST mesh for reinforcement of the primary crural closure in patients undergoing elective, laparoscopic PEH repair.

Methods:

A prospective database was initiated and maintained for all patients undergoing PEH repair with the use of Phasix-ST mesh. We retrospectively reviewed the records of consecutive patients who had an elective, first-time laparoscopic PEH repair with Phasix-ST mesh and who completed their 1-year objective follow-up study. Patients having a reoperation, non-laparoscopic repair, or who failed to comply with the objective follow-up were excluded.

Results:

To achieve the desired 50 patients with 1-year objective follow-up, we reviewed the records of 90 consecutive PEH patients. In the final cohort of 50 patients, there were 32 females (64%) and 18 males. The median age of the patients at surgery was 67 years (range 44–84). The operation was PEH repair with fundoplication alone in 29 patients (58%) and PEH repair with Collis gastroplasty and fundoplication in 21 patients (42%). Phasix-ST mesh was used for crural reinforcement in all patients, and there were no intraoperative issues with the mesh or any difficulty placing or fixating the mesh at the hiatus. A diaphragm relaxing incision was performed in 2 patients (4%). The mean length of hospital stay was 2.8 days, and there was no major morbidity or mortality. On the 1-year objective follow-up study (median 12 months) a recurrent hernia was found in 4 patients (8%). No patient that had a Collis gastroplasty or a relaxing incision had a recurrent hernia. No patient had a reoperation. No patient had a mesh infection or mesh erosion.

Conclusions:

Phasix-ST mesh reinforcement of the crural closure during laparoscopic primary, elective PEH repair was associated with no adverse mesh-related events such as infection or erosion. Phasix-ST crural reinforcement in combination with tension-reduction techniques when necessary resulted in a very low (8%) objective hernia recurrence rate at a median follow-up of 1 year. These results demonstrate the safety of Phasix-ST mesh for use at the hiatus for crural reinforcement. This safety, along with the encouraging short-term efficacy for reducing hernia recurrence, should encourage further studies using the combination of resorbable biosynthetic mesh crural reinforcement and tension-reducing techniques during repair of paraesophageal hernias.

The History of GalaFLEX P4HB Scaffold

Category: Review
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Simon F. Williams, PhD; David P. Martin, PhD; and Arikha C. Moses, PhD

Aesthetic Surgery Journal 36(2):S33-S42. 2016   

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/27697885

ABSTRACT

The GalaFLEX Scaffold (Galatea Surgical, Inc., Lexington, MA) for plastic and reconstructive surgery belongs to a new generation of products for soft tissue reinforcement made from poly-4- hydroxybutyrate (P4HB). Other members of this new family of products include MonoMax Suture (Aesculap AG, Tuttlingen, Germany) for soft tissue approximation, BioFiber Scaffold (Tornier, Inc., Edina, MN) for tendon repair, and Phasix Mesh (C.R. Bard, Inc., Murray Hill, NJ) for hernia repair. Each of these fully resorbable products provides prolonged strength retention, typically 50% to 70% strength retention at 12 weeks, and facilitates remodeling in vivo to provide a strong, lasting repair. P4HB belongs to a naturally occurring class of biopolymers and fibers made from it are uniquely strong, flexible, and biocompatible. GalaFLEX Scaffold is comprised of high-strength, resorbable P4HB monofilament fibers. It is a knitted macroporous scaffold intended to elevate, reinforce, and repair soft tissue. The scaffold acts as a lattice for new tissue growth, which is rapidly vascularized and becomes fully integrated with adjacent tissue as the fibers resorb. In this review, we describe the development of P4HB, its production, properties, safety, and biocompatibility of devices made from P4HB. Early clinical results and current clinical applications of products made from P4HB are also discussed. The results of postmarket clinical studies evaluating the GalaFLEX Scaffold in rhytidectomy andcosmetic breast surgery demonstrate that the scaffold can reinforce lifted soft tissue, resulting in persistent surgical results in the face and neck at one year, and provide lower pole stability after breast lift at one year.

DISCLOSURES

Device: GalaFLEX Scaffold

Use: The FDA does not consider the use of the manufacturer’s device as described in this Publication to be within the cleared indications for use statement. 

Authors and Funding: Galatea Surgical, Inc., a wholly owned subsidiary of Tepha, Inc., provided the funding for the article. 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. Dr. Arihka Moses is the Founder of Galatea Surgical, Inc.

Risk: Significant risks or safety concerns associated with the use of GalaFLEX Scaffold known to the manufacturer are described in the Instructions for Use.

Initial Experience With Biologic Polymer Scaffold (Poly-4-hydroxybuturate) in Complex Abdominal Wall Reconstruction

Category: Clinical
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Joseph Buell; David Sigmon; Christopher Ducoin; Max Shapiro; Nikhil Teja; Emmett Wynter; Mary Hanisee; Geoffrey Parker; Emad Kandil; Michael Darden;

Annals of Surgery. 266(1):185–188. 2017

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/28594679

ABSTRACT

Objective: To evaluate the use of the new absorbable polymer scaffold poly-4-hydroxybutyrate (P4HB) in complex abdominal wall reconstruction.

Background: Complex abdominal wall reconstruction has witnessed tremendous success in the last decade after the introduction of cadaveric biologic scaffolds. However, the use of cadaveric biologic mesh has been expensive and plagued by complications such as seroma, infection, and recurrent hernia. Despite widespread application of cadaveric biologic mesh, little data exist on the superiority of these materials in the setting of high-risk wounds in patients. P4HB, an absorbable polymer scaffold, may present a new alternative to these cadaveric biologic grafts.

Methods: A retrospective analysis of our initial experience with the absorbable polymer scaffold P4HB compared with a consecutive contiguous group treated with porcine cadaveric mesh for complex abdominal wall reconstructions. Our analysis was performed using SAS 9.3 and Stata 12.

Results:
The P4HBgroup (n¼31) experienced shorter drain time(10.0 vs 14.3 d; P < 0.002), fewer complications (22.6% vs 40.5%; P < 0.046), and reherniation (6.5% vs 23.8%; P < 0.049) than the porcine cadaveric mesh group (n¼ 42). Multivariate analysis for infection identified: porcine cadaveric mesh odds ratio 2.82, length of stay odds ratio 1.11; complications: drinker odds ratio 6.52, porcine cadaveric mesh odds ratio 4.03, African American odds ratio 3.08, length of stay odds ratio 1.11; and hernia recurrence: porcine cadaveric mesh odds ratio 5.18, drinker odds ratio 3.62, African American odds ratio 0.24. Cost analysis identified that P4HB had a $7328.91 financial advantage in initial hospitalization and $2241.17 in the 90-day post discharge global period resulting in $9570.07 per case advantage over porcine cadaveric mesh.

Conclusions: In our early clinical experience with the absorbable polymer matrix scaffold P4HB, it seemed to provide superior clinical performance and value-based benefit compared with porcine cadaveric biologic mesh.

Reducing Postoperative Abdominal Bulge Following Deep Inferior Epigastric Perforator Flap Breast Reconstruction with Onlay Monofilament Poly-4-Hydroxybutyrate Biosynthetic Mesh

Category: Clinical
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Blair A. Wormer, MD; Nicholas W. Calvin, MD; Jean-Francois Lefaivre, MD; Jason M. Korn, MD; Edward Teng, MD; Anthony S. Aukskalnis, BA; J. Michael Robinson, MD

Division of Plastic Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina

Journal of Reconstructive Microsurgery

September 5, 2016


Full Article

ABSTRACT

The purpose of this study was to evaluate the use of a biosynthetic mesh onlay on reducing postoperative abdominal bulge following deep inferior epigastric perforator (DIEP) flap breast reconstruction.

Methods: All patients undergoing DIEP reconstructions from January, 2010 to January, 2014 at a tertiary center were reviewed. Patients were divided into two groups for comparison based on whether a biosynthetic mesh onlay (Phasix [monofilament poly-4-hydroxybutyrate], Bard Inc., Warwick, RI) was used for reinforcement of the anterior rectus fascia. Rates of postoperative abdominal bulge were compared between the groups utilizing standard statistical methods.

Results: During the study period, 319 patients underwent 553 DIEP reconstructions, 160 (50.2%) used mesh and 159 (49.8%) did not (nonmesh). The mean follow-up was 16.4 ± 11.1 months. There was no difference in age (49 ± 9.3 years), current tobacco use, diabetes, or mean body mass index (BMI, 29.4 ± 4.4) between the mesh and nonmesh groups (p > 0.05); however, there was a higher proportion of obese patients (BMI > 30) in the mesh group (45.0 vs. 33.3%; p = 0.03). Abdominal bulge rate following DIEP with mesh was lower than the nonmesh group (0 vs. 5.0%; p = 0.004). In the entire sample, 234 (73.4%) underwent bilateral DIEP and 85 (26.6%) underwent unilateral DIEP. In unilateral DIEP patients, the bulge rate was similar between the mesh and nonmesh groups (0 vs. 4.4%; p > 0.05); however, in bilateral DIEP patients, the bulge rate was lower in the mesh group compared with a nonmesh group (0 vs. 5.5%; p = 0.008).

Conclusion: Reinforcement of the anterior rectus with an onlay monofilament poly-4-hydroxybutyrate biosynthetic mesh may reduce the risk of postoperative bulge rate in patients undergoing DIEP reconstruction.

 

DISCLOSURES

None

Poly-4-hydroxybutyrate (P4HB): A new generation of resorbable medical devices for tissue repair and regeneration.

Category: Review
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Simon F. Williams, PhD; Said Rizik, MS; and David P. Martin, PhD

Biomedical Engineering 58(5):1-14.2013

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/23979121

ABSTRACT

Poly-4-hydroxybutyrate (P4HB) is a thermoplastic, linear polyester, produced by recombinant fermentation, that can be converted into a wide range of resorbable medical devices. P4HB fibers are exceptionally strong, and can be designed to provide prolonged strength retention in vivo. In 2007, the FDA cleared a monofilament suture made from P4HB for general soft tissue approximation and/or ligation. Subsequently, surgical mesh devices for hernia repair, tendon and ligament repair, and plastic and reconstructive surgery have been introduced for clinical use. This review describes the unique properties of P4HB, its clinical applications, and potential uses that are under development.

DISCLOSURES

Tepha, Inc., the parent company of Galatea Surgical, Inc., provided the funding for this article. 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 is an employee of Tepha, Inc.

PHA Applications: Addressing the price performance issue: I. Tissue engineering.

Category: Review
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Simon F Williams, PhD; David P Martin, PhD; Daniel M Horowitz, PhD; and Oliver P Peoples, PhD

International Journal of Biological Macromolecules 25(1-3):111-21.1999

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/10416657

ABSTRACT

This paper describes the development of medical applications for polyhydroxyalkanoates (PHAs), a class of natural polymers with a wide range of thermoplastic properties. Methods are described for preparing PHAs with high purity, modifying these materials to change their surface and degradation properties, and methods for fabricating them into different forms, including tissue engineering scaffolds. Preliminary reports characterizing their in vivo behavior are given, as well as methods for using the natural polymers in tissue engineering applications.

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.