The Material Difference
Phasix™ Plug and Patch
Phasix™ Hernia Plug
Fully Resorbable Implant for Soft Tissue Reconstruction
A material option that provides a strong durable repair without long-term foreign material. Bard’s Phasix™ material provides you and your patients an option for inguinal hernia repair that provides a strong durable repair, without permanent foreign material.
Material ValueChronic pain is a serious complication that can occur after repair of groin hernia.1 The development of chronic pain after herniorraphy has been attributed to several mechanisms, including damage to sensory nerves and mesh inguinodynia.2 Phasix™ Plug and Patch provides the advantages of a clinically proven technique3 with a fully resorbable mesh to potentially further reduce the risk of chronic pain.
Material Science Phasix™ Plug and Patch is constructed of monofilament Poly-4-Hydroxybutyrate (P4HB), a fully resorbable synthetic material developed by MIT scientists. The monomer form of the substance, (4HB) occurs naturally and is widely distributed in the tissues of mammals (including humans).4 P4HB has been available for clinical use since 2007.
Mesh Type(N=10)
Suture Retention Strength,parallel/perpendicular (N)
Tear Resistance, parallel/perpendicular (N)
Ball Burst Strength (N/cm)
Phasix™ Mesh 40 / 45 37 / 50 149Bard® Mesh 54 / 36 46 / 49 213
Threshold values suggested as suitable properties for hernia repair applications
>20 N >20 N >50 N/cm
Phasix™ Plug and Patch
Phasix™ Mesh Structure, SEM photo, 20X
1 Nienhuijs S et. al. “Chronic pain after mesh repair of inguinal hernia: a systematic review.” Am J Surg. 2007;194(3):394-400.2 Demierer S, et. al. “The Effect of Polypropylene Mesh on Ilioinguinal Nerve in Open Mesh Repair of Groin Hernia.” Journal of Surgical Research. 2006 (131): 175-181.3 Millikan KW., Doolas A. “A Long-Term Evaluation of the Modified Mesh-Plug Hernioplasty in Over 2,000 Patients.” Hernia. 2008 Jun; 12(3): 257-260.4 Martin DP, Williams SF. “Medical Applications of Poly-4-Hydroxybutyrate: A Strong Flexible Absorbable Biomaterial.” Biochemical Engineering Journal. 2003 (16): 97-105. 5 Preclinical data on file at C. R. Bard, Inc. Results may not correlate to performance in humans. 6 Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical Evaluation of Absorbable and Nonabsorbable Barrier Composite Meshes for Laparascopic Ventral Hernia Repair.” Surg Endosc. 2011 May 25(5): 1541-52. 7 Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical Evaluation of Polypropylene, Polyester, and Polytetrafluoroethylene Meshes for Inguinal Hernia Repair.” J Am Coll Surg. 2011; 212:1-12.8 Benchtop testing data on file at C. R. Bard, Inc.
Material StructurePhasix™ Plug and Patch is a woven monofilament mesh that provides immediate short-term support similar to traditional non-resorbable meshes but provides a scaffold that enables remodeling to host tissue over time. The Phasix™ Plug and Patch supports host tissue formation at the repair site and predictably and gradually degrades via hydrolysis such that mechanical strength is gone within 12 to 18 months, and while fiber segments were observed at 18 months, they continue to degrade until fully resorbed, as demonstrated in a preclinical study.5
Suture pull-out, tear and ball burst strength of Phasix™ Mesh are comparable to traditional Bard® polypropylene mesh and the performance of Phasix™ Mesh is above the threshold values set by Deeken et. al., for resorbable and non-resorbable barrier composite meshes.5,6,7,8
MonoMax® P4HB Suture and TephaFLEX®
Surgical Mesh commercially available.
MonoMax® P4HB Suture launched by B Braun.P4HB technology
developed by MIT scientists
Davol Inc. licensed TephaFLEX® Mesh from Tepha, Inc. Re-branded product as
Phasix™ Mesh.Davol Inc. launch of Phasix™ Mesh.
MonoMax® P4HB Suture first human use.
TephaFLEX® Surgical Mesh implanted into first human cases.
Phasix™ Mesh preclinical studies
completed by Davol Inc.
2007
2008
2009 2011
2012
2013
2010
Material Impact Phasix™ Plug and Patch provides the high levels of early strength needed to support tissue healing and gradually shifts mechanical load to the host tissue as the repair matures.9
Material Integration and PerformancePhasix™ Plug and Patch allows the assembly of new collagen around a macroporous scaffold which resorbs slowly over
time and is replaced with new host collagen.9
Study Type: Preclinical Study - 25 male Yucatan mini-pigs (33.7-41.8 kg)Objective: Demonstrate the strength over time of Phasix™ PlugStudy Design: Preperitoneal bridge defect repair. A 3 cm round full thickness defect was created in the ventral
abdominal wall. Phasix™ Plug was fixated through the defect with suture. Ball burst testing and histopathology were conducted at T=0, 6 weeks, 12 weeks, 26 weeks, and 52 weeks.
Results: Significant strength over time and early tissue in-growth at bridged site was demonstrated.
Phasix™ Mesh, 52 weeks, MT, 10x
Blue: Collagen Purple: Macrophages surrounding monfilaments; mild host inflammatory response
Phasix™ Mesh, 52 weeks, vWF, 10x
Brown: Blood Vessels
9 Preclinical data on file at C. R. Bard, Inc. Results may not correlate to performance in humans.
Repair strength remained significantly above the native abdominal wall throughout the 52 week mesh absorption period (P<0.05 for all time-points).9
Native Porcine Abdominal Wall
Repair Strength Over Time - Phasix™ Plug 52 Week Preclinical Data
Burs
t Stre
ngth
(N)
300
350
250
200
150
100
50
00 6 12 26 52
400
Preclinical testing confirmed early tissue in-growth, vascular integration and incorporation of the Phasix™ Plug into the ventral abdominal wall. Abundant mature collagen has formed around the remaining fibers at 52 weeks.9
(T=0, N=10; T=6-52 weeks, N=5)
Davol Inc. • Subsidiary of C. R. Bard, Inc.100 Crossings Boulevard • Warwick, RI 02886
1.800.556.6275 • www.davol.com
Medical Services & Support 1.800.562.0027
10 Bard PerFix™ Plug Technique Guide 11 Phasix™ Plug and Patch Instructions for Use
Product Codes
Product Code Quantity Sizes Dimensions
1190600 1/cs Small 1.0" x 1.4" (2.5 cm x 3.6 cm) q
1190601 1/cs Medium 1.3" x 1.6" (3.3 cm x 4.1 cm) q
1190602 1/cs Large 1.5" x 1.9" (4.1 cm x 4.8 cm) q
1190603 1/cs Extra Large 1.4" x 2.0" (3.8 cm x 5.1 cm) q
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Mesh Design and PlacementLike the Bard® PerFix™ Plug, the Phasix™ Plug is designed with pleated edges that conform readily to defects of various sizes and shapes and inner petals that allow the plug to maintain its fluted form. The Phasix™ Plug and Patch may be implanted using the Millikan Modified Technique to create a multi-layered, tension free repair that is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.10,11
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Indirect Patch Placement Direct Plug Placement
IndicationsThe Phasix™ Plug and Patch is indicated for reinforcement of soft tissue where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
ContraindicationsBecause Phasix™ Plug and Patch is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.
WarningsPlacement of Phasix™ Plug and Patch in direct contact with bowel or viscera is not recommended. The safety and product use for patients with hypersensitivities to tetracycline hydrochloride or kanamycin sulfate is unknown. Use of this device
in patients with known allergies to these antibiotics should be avoided. The safety and effectiveness of Phasix™ Plug and Patch in pediatric use and use in pregnant women has not been established. If an infection develops, treat the infection aggressively. An unresolved infection may require removal of the device.
Adverse ReactionsPossible complications include infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the hernia or soft tissue defect.
Please consult package insert for more detailed safety information and instructions for use.
A material option that provides a strong durable repair without long-term foreign material.
To learn more, contact your local BARD sales representative or call 1.800.556.6275
Bard, Davol and Phasix are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. © Copyright 2013, C. R. Bard, Inc. All Rights Reserved. MMPXPPSS
