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A clinically proven umbilical hernia repair solution with SorbaFlex™ Memory Technology and an absorbable barrier featuring Sepra® Technology.
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Ventralex™ ST
Hernia Patch
A clinically proven umbilical hernia repair solution designed for ventral, incisional, umbilical and epigastric hernia repair as well as trocar site closure, with an absorbable barrier featuring Sepra® technology.
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true
Anterior layer
Uncoated Mesh
Monofilament polypropylene mesh designed to allow a prompt fibroblastic response through the open interstices of the mesh.
Design
SorbaFlex™ Memory Technology
Polydioxanone (PDO) monofilament is unique in its flexibility and tensile strength, facilitating patch insertion and placement. Preclinical testing has demonstrated that absorption via hydrolysis is essentially complete in 6-8 months.4
Unique Pocket and Strap Design
Pocket and strap facilitate placement, positioning and lateral fixation. SorbaFlex™ Memory Technology is contained within a knitted polypropylene mesh tube.
Posterior layer
Sepramesh™ IP Composite
Unique hydrogel barrier, based on the Sepra® Technology, swells to minimize tissue attachment to the visceral side of the mesh and resorbs within 30 days providing visceral protection during the critical healing process.3
Sepramesh™ IP Composite Preclinical Study2,3
“120-Day Comparative Analysis of Adhesion Grade and Quantity, Mesh Contraction, and Tissue Response to a Novel Omega-3 Fatty Acid Bioresorbable Barrier Macroporous Mesh After Intraperitoneal Placement.
The Ventralex™ ST Hernia Patch Advantage
Easy
Minimum dissection, fixation required.
Efficient
Proprietary pocket and strap design facilitates placement, positioning and lateral fixation.
Proven
Clinically supported technique since 2002 with over 800,000 implants worldwide and peer-reviewed published clinical studies.
1 Majercik, S. et al. “Strength of tissue attachment to mesh after ventral hernia repair with synthetic composite mesh in a porcine model.” Surg Endos. (2006) 20: 1671-1674.
2 Results may not correlate to performance in humans.
3 Pierce, Richard A. MD, PhD, et al. Surgical Innovation. March 2009; 16, 1:45-54.
4 Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans.
5 These images are from a porcine study using the Ventrio™ Hernia Patch which contains the same SorbaFlex™ Memory Technology
6 Tinella A, Malvasi A, Manca C, Alemanno G, Bettocchi S, Benhidjeb T. “Post-laparoscopic mesh in post-menopausal umbilical hernia repair: a case series.” Minim Invasive Ther Allied Technol. 2011 Sep; 20(5):290-5.
7 Iversen E, Lykke A, Hensler M, Jorgensen LN. “Abdominal wall hernia repair with a composite ePTFE/polypropylene mesh: clinical outcome and quality of life in 152 patients.” Hernia. 2010 Dec;14(6): 555-60.
8 Vychnevskaia K, Mucci-Hennekinne S, Casa C, et al. “Intraperitoneal mesh repair of small ventral abdominal wall hernias with a Ventralex™ Hernia Patch.” Dig Surg. 2010; 27(5): 433-5.
9 D.F. Martin, R.F. Williams, T. Mulrooney, and G.R. Voeller. “Ventralex™ Mesh in Umbilical/Epigastric Hernia Repairs: Clinical Outcomes and Complications.” Hernia. 2008 Aug 12(4) 379-83.
10 H.I.A. Hadi, A. Maw, S. Sarmah, P. Kumar. “Intraperitoneal Tension-Free Repair of Small Midline Ventral Abdominal Wall Hernias With a Ventralex™ Hernia Patch: Initial Experience in 51 Patients.” Hernia. 2006: 10:409-413.
INDICATIONS
The Ventralex™ ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias and deficiencies caused by trocars.
CONTRAINDICATIONS
Do not use the Ventralex™ ST Hernia Patchin infants or children, whereby future growth will be compromised by the use of such mesh material. Do not use the Ventralex™ ST Hernia Patch for the reconstruction of cardiovascular defects. Literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.
WARNINGS
Do not cut or reshape the Ventralex™ ST Hernia Patch, as this could impact its effectiveness, except for the polypropylene positioning strap. Care should be taken not to cut or nick the SorbaFlex™PDO monofilament during insertion or fixation. If the SorbaFlex™PDO monofilament is cut or damaged, additional complications may include bowel or skin perforation and infection. Follow proper folding techniques for all patches as described in these Instructions for Use as other folding techniques may compromise the SorbaFlex™ PDO monofilament. Ensure proper orientation; the bioresorbable coated side of the prosthesis should be oriented against the bowel or sensitive organs. Do not place the polypropylene mesh side against the bowel. There may be a possibility for adhesion formation when the mesh is placed in direct contact with the bowel or viscera.
ADVERSE REACTIONS
Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation, infection, allergic reaction, and recurrence of the hernia or soft tissue defect. If the SorbaFlex™ PDO monofilament is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection.
Please consult package insert for more detailed safety information and instructions for use.
true
BD-14797
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Ventralex™ ST Hernia Patch, Large Circle with Strap, 3.2 in x 3.2 in (8.0 cm x 8.0 cm)
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Ventralex™ ST Hernia Patch, Medium Circle with Strap, 2.5 in x 2.5 in (6.4 cm x 6.4 cm)
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Ventralex™ ST Hernia Patch, Small Circle with Strap, 1.7 in x 1.7 in (4.3 cm x 4.3 cm)
1 Majercik, S. et al. “Strength of tissue attachment to mesh after ventral hernia repair with synthetic composite mesh in a porcine model.” Surg Endos. (2006) 20: 1671-1674.
2 Results may not correlate to performance in humans.
3 Pierce, Richard A. MD, PhD, et al. Surgical Innovation. March 2009; 16, 1:45-54.
4 Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans.
5 These images are from a porcine study using the Ventrio™ Hernia Patch which contains the same SorbaFlex™ Memory Technology
6 Tinella A, Malvasi A, Manca C, Alemanno G, Bettocchi S, Benhidjeb T. “Post-laparoscopic mesh in post-menopausal umbilical hernia repair: a case series.” Minim Invasive Ther Allied Technol. 2011 Sep; 20(5):290-5.
7 Iversen E, Lykke A, Hensler M, Jorgensen LN. “Abdominal wall hernia repair with a composite ePTFE/polypropylene mesh: clinical outcome and quality of life in 152 patients.” Hernia. 2010 Dec;14(6): 555-60.
8 Vychnevskaia K, Mucci-Hennekinne S, Casa C, et al. “Intraperitoneal mesh repair of small ventral abdominal wall hernias with a Ventralex™ Hernia Patch.” Dig Surg. 2010; 27(5): 433-5.
9 D.F. Martin, R.F. Williams, T. Mulrooney, and G.R. Voeller. “Ventralex™ Mesh in Umbilical/Epigastric Hernia Repairs: Clinical Outcomes and Complications.” Hernia. 2008 Aug 12(4) 379-83.
10 H.I.A. Hadi, A. Maw, S. Sarmah, P. Kumar. “Intraperitoneal Tension-Free Repair of Small Midline Ventral Abdominal Wall Hernias With a Ventralex™ Hernia Patch: Initial Experience in 51 Patients.” Hernia. 2006: 10:409-413.
INDICATIONS
The Ventralex™ ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias and deficiencies caused by trocars.
CONTRAINDICATIONS
Do not use the Ventralex™ ST Hernia Patchin infants or children, whereby future growth will be compromised by the use of such mesh material. Do not use the Ventralex™ ST Hernia Patch for the reconstruction of cardiovascular defects. Literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.
WARNINGS
Do not cut or reshape the Ventralex™ ST Hernia Patch, as this could impact its effectiveness, except for the polypropylene positioning strap. Care should be taken not to cut or nick the SorbaFlex™PDO monofilament during insertion or fixation. If the SorbaFlex™PDO monofilament is cut or damaged, additional complications may include bowel or skin perforation and infection. Follow proper folding techniques for all patches as described in these Instructions for Use as other folding techniques may compromise the SorbaFlex™ PDO monofilament. Ensure proper orientation; the bioresorbable coated side of the prosthesis should be oriented against the bowel or sensitive organs. Do not place the polypropylene mesh side against the bowel. There may be a possibility for adhesion formation when the mesh is placed in direct contact with the bowel or viscera.
ADVERSE REACTIONS
Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation, infection, allergic reaction, and recurrence of the hernia or soft tissue defect. If the SorbaFlex™ PDO monofilament is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection.
Please consult package insert for more detailed safety information and instructions for use.
true
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1 Majercik, S. et al. “Strength of tissue attachment to mesh after ventral hernia repair with synthetic composite mesh in a porcine model.” Surg Endos. (2006) 20: 1671-1674.
2 Results may not correlate to performance in humans.
3 Pierce, Richard A. MD, PhD, et al. Surgical Innovation. March 2009; 16, 1:45-54.
4 Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans.
5 These images are from a porcine study using the Ventrio™ Hernia Patch which contains the same SorbaFlex™ Memory Technology
6 Tinella A, Malvasi A, Manca C, Alemanno G, Bettocchi S, Benhidjeb T. “Post-laparoscopic mesh in post-menopausal umbilical hernia repair: a case series.” Minim Invasive Ther Allied Technol. 2011 Sep; 20(5):290-5.
7 Iversen E, Lykke A, Hensler M, Jorgensen LN. “Abdominal wall hernia repair with a composite ePTFE/polypropylene mesh: clinical outcome and quality of life in 152 patients.” Hernia. 2010 Dec;14(6): 555-60.
8 Vychnevskaia K, Mucci-Hennekinne S, Casa C, et al. “Intraperitoneal mesh repair of small ventral abdominal wall hernias with a Ventralex™ Hernia Patch.” Dig Surg. 2010; 27(5): 433-5.
9 D.F. Martin, R.F. Williams, T. Mulrooney, and G.R. Voeller. “Ventralex™ Mesh in Umbilical/Epigastric Hernia Repairs: Clinical Outcomes and Complications.” Hernia. 2008 Aug 12(4) 379-83.
10 H.I.A. Hadi, A. Maw, S. Sarmah, P. Kumar. “Intraperitoneal Tension-Free Repair of Small Midline Ventral Abdominal Wall Hernias With a Ventralex™ Hernia Patch: Initial Experience in 51 Patients.” Hernia. 2006: 10:409-413.
INDICATIONS
The Ventralex™ ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias and deficiencies caused by trocars.
CONTRAINDICATIONS
Do not use the Ventralex™ ST Hernia Patchin infants or children, whereby future growth will be compromised by the use of such mesh material. Do not use the Ventralex™ ST Hernia Patch for the reconstruction of cardiovascular defects. Literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.
WARNINGS
Do not cut or reshape the Ventralex™ ST Hernia Patch, as this could impact its effectiveness, except for the polypropylene positioning strap. Care should be taken not to cut or nick the SorbaFlex™PDO monofilament during insertion or fixation. If the SorbaFlex™PDO monofilament is cut or damaged, additional complications may include bowel or skin perforation and infection. Follow proper folding techniques for all patches as described in these Instructions for Use as other folding techniques may compromise the SorbaFlex™ PDO monofilament. Ensure proper orientation; the bioresorbable coated side of the prosthesis should be oriented against the bowel or sensitive organs. Do not place the polypropylene mesh side against the bowel. There may be a possibility for adhesion formation when the mesh is placed in direct contact with the bowel or viscera.
ADVERSE REACTIONS
Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation, infection, allergic reaction, and recurrence of the hernia or soft tissue defect. If the SorbaFlex™ PDO monofilament is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection.
Please consult package insert for more detailed safety information and instructions for use.
true