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Ventralex™ ST Hernia Patch for Surgery & Repair
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.
Easy. Efficient. Proven for Hernia Repair.
A clinically proven umbilical hernia repair solution with SorbaFlex™ Memory Technology and an absorbable barrier featuring Sepra® Technology.
Ideal for herniation into a trocar site, along with Richter’s hernias. The smallest Ventralex™ ST Hernia Patch allows for an intraabdominal, tension-free repair with no transfascial suturing.
Anterior layer of the Ventralex™ ST Hernia Patch
Monofilament polypropylene mesh designed to allow a prompt fibroblastic response through the open interstices of the mesh.
Designed for a strong hernia repair
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
Pocket and strap facilitate placement, positioning and lateral fixation. SorbaFlex™ Memory Technology is contained within a knitted polypropylene mesh tube.
Posterior layer of the hernia patch
The Sepramesh™ IP Composite is a 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
Bioresorbable PGA fibers reinforce the integrity of the hydrogel barrier by binding it to the polypropylene mesh.
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.
Herniation into a trocar site, along with Richter’s hernias, may occur even if the anterior fascia above the defect has been closed. The smallest Ventralex™ ST Hernia Patch allows for an intraabdominal, tension-free repair with no transfascial suturing.
Proven for ventral, incisional, umbilical and epigastric hernia repair
Clinical Summary “ Ventralex Mesh in Umbilical/Epigastric Hernia Repairs: Clinical Outcomes and Complications” (Hernia / 2008)
• 88 patients (69 male, 19 female) were evaluated from 2003-2006 and 89 Ventralex™ Hernia Patches were placed.
• 0 hernia recurrences.
Highlights
“Interrupted nonabsorbable 2-0 Prolene U-stitches are used at the 12 and 6 o’clock position for the 4.3 cm patch and at the 12, 3, 6 and 9 o’clock position for the 6.4 cm patch, attaching only the polypropylene part of the patch to the fascia.”
“We believe our attention to meticulous technique, securing the patch to good healthy fascia at least 2 cm beyond the defect, placement of the patch behind the defect, and re-approximating the fascia over the patch are essential to our low complication and recurrence rate.
Ventralex™ ST Hernia Patch Compared to Parietex™ Ventral Patch
Parietex™ Ventral Patch is porcine based and absorbs in 21 days. It has two removal handles composed of colored tubes and yarns and four flaps (one at each corner of the device) made up of bidimensional monofilament polyester. It also has two dyed PGLA poly (glycolide-co-L-lactide) expanders. The PGLA component is completely absorbed prior to one year.
Sepramesh™ IP Composite’s 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. Sepra® Technology swells over 60% more than Parietex™ Composite barrier. Additionally, monofilament polypropylene mesh allows a prompt fibroblastic response through the open interstices of the mesh.
To read more on the comparison of these two products, check out our in-depth review here.
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.
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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)
Ventralex™ ST Hernia Patch, Medium Circle with Strap, 2.5 in x 2.5 in (6.4 cm x 6.4 cm)
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.
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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.
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