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SorbaFix™ Absorbable Fixation System

Absorbable PDLLA fasteners available in both a 15 and 30 count configuration delivered via a disposable 5 mm applier.

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Overview

Smart Design. Not Sharp Design

The unique fastener design of the SorbaFix™ Absorbable Fixation system means no sharp points are left behind in the patient. Preclinical data shows that a hollow core allows tissue in-growth through the fastener.2 The 5 mm depth of tissue purchase and consistent thread diameter from head to tip assure maximum tissue engagement during open and laparoscopic procedures. TheSorbaFix™ Absorbable Fixation System has a 5 mm, low-profile delivery system that offers smooth, efficient deployment. Keeping track of the pre-loaded 15- or 30-fastener configurations is now easy with a new fastener gauge.

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Features and Benefits
Strong:
  • Repair strength approximately 7x greater than maximum Intraabdominal Pressure (IAP). 1, 2
  • Threaded, hollow core allows for tissue in-growth through interior of fastener.2

 

Shear strength retention illustrates degradation of the SorbaFix™ fastener over time. The SorbaFix™ fastener retains 100% of its strength within the first 2 months, providing secure fixation during the initial healing period.2

Preclinical data. Results may not correlate to performance in humans.

Consistent:
  • The consistent diameter of the threads from head to tip and fastener length are designed to maximize tissue engagement.
  • Obturator with piloting tip accurately pilots fastener through mesh and tissue.
Reliable:
  • Atraumatic blunt tip fastener with smooth head and no exposed points.
  • Innovative mechanical design enables a durable delivery system.
  • Absorption of the poly (D, L) – lactide (PDLLA) fasteners is nearly complete at approximately 12 months post implantation, leaving less foreign material behind.2
Reference

1. Twardowski ZJ et al “Intraabdominal Pressures during Natural Activities in Patients Treated with Continuous Ambulatory Peritoneal Dialysis” Nephron 44:129-135 1986. Cobb WS et al. "The Argument for Lightweight Polypropylene Mesh in Hernia Repair" Surgical Innovation. Vol 12 (1).63-69, 2005.

2. Data generated from an animal study using the SORBAFIX™ Absorbable Fixation System and from a cadaver study using the PERMAFIX™ Permanent Fixation System. Data on file. Results may not correlate to performance in humans.

Indications

The SorbaFix™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Contraindications

Contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply including but not limited to:

  • Fixation of vascular or neural structures
  • Fixation of bone and cartilage
  • Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is resorbed.
  • Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera or bone. Use of the SorbaFix™ Absorbable Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener is 6.0 mm, the fastener head is another 0.7 mm (total 6.7 mm).

Warnings

The device may not fixate through prosthetics derived from biologic material such as xenografts and allografts. Prosthetic should be evaluated for compatibility prior to use. To prevent patient injury from the piloting tip, stay clear of vessels, nerves, bowel and viscera when entering the surgical site, manipulating tissue and fixating mesh. After use, the SorbaFix™ Absorbable Fixation System may be a potential biohazard. This device has a piloting tip, which should be considered a sharp even when the device is not actuated. Handle and dispose of in accordance with any local and federal laws regarding medical waste and sharps disposal requirements to prevent sharps injuries.

Adverse Reactions

Adverse reactions and potential complications associated with fixation devices such as the SorbaFix™ Absorbable Fixation System may include, but are not limited to the following: hemorrhage; pain, edema and erythema at wound site; allergic reaction to Poly (D, L)-lactide; septicemia/infection; hernia recurrence/wound dehiscence.

Please consult package insert for more detailed safety information and instructions for use.

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BD-15156

Products & Accessories
  • product-image

    SorbaFix™ Absorbable Fixation System - 30 Fasteners

  • product-image

    SorbaFix™ Absorbable Fixation System - 15 Fasteners

References

1. Twardowski ZJ et al “Intraabdominal Pressures during Natural Activities in Patients Treated with Continuous Ambulatory Peritoneal Dialysis” Nephron 44:129-135 1986. Cobb WS et al. "The Argument for Lightweight Polypropylene Mesh in Hernia Repair" Surgical Innovation. Vol 12 (1).63-69, 2005.

2. Data generated from an animal study using the SORBAFIX™ Absorbable Fixation System and from a cadaver study using the PERMAFIX™ Permanent Fixation System. Data on file. Results may not correlate to performance in humans.

Indications

The SorbaFix™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Contraindications

Contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply including but not limited to:

  • Fixation of vascular or neural structures
  • Fixation of bone and cartilage
  • Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is resorbed.
  • Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera or bone. Use of the SorbaFix™ Absorbable Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener is 6.0 mm, the fastener head is another 0.7 mm (total 6.7 mm).

Warnings

The device may not fixate through prosthetics derived from biologic material such as xenografts and allografts. Prosthetic should be evaluated for compatibility prior to use. To prevent patient injury from the piloting tip, stay clear of vessels, nerves, bowel and viscera when entering the surgical site, manipulating tissue and fixating mesh. After use, the SorbaFix™ Absorbable Fixation System may be a potential biohazard. This device has a piloting tip, which should be considered a sharp even when the device is not actuated. Handle and dispose of in accordance with any local and federal laws regarding medical waste and sharps disposal requirements to prevent sharps injuries.

Adverse Reactions

Adverse reactions and potential complications associated with fixation devices such as the SorbaFix™ Absorbable Fixation System may include, but are not limited to the following: hemorrhage; pain, edema and erythema at wound site; allergic reaction to Poly (D, L)-lactide; septicemia/infection; hernia recurrence/wound dehiscence.

Please consult package insert for more detailed safety information and instructions for use.

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Resources
References

1. Twardowski ZJ et al “Intraabdominal Pressures during Natural Activities in Patients Treated with Continuous Ambulatory Peritoneal Dialysis” Nephron 44:129-135 1986. Cobb WS et al. "The Argument for Lightweight Polypropylene Mesh in Hernia Repair" Surgical Innovation. Vol 12 (1).63-69, 2005.

2. Data generated from an animal study using the SORBAFIX™ Absorbable Fixation System and from a cadaver study using the PERMAFIX™ Permanent Fixation System. Data on file. Results may not correlate to performance in humans.

Indications

The SorbaFix™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Contraindications

Contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply including but not limited to:

  • Fixation of vascular or neural structures
  • Fixation of bone and cartilage
  • Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is resorbed.
  • Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera or bone. Use of the SorbaFix™ Absorbable Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener is 6.0 mm, the fastener head is another 0.7 mm (total 6.7 mm).

Warnings

The device may not fixate through prosthetics derived from biologic material such as xenografts and allografts. Prosthetic should be evaluated for compatibility prior to use. To prevent patient injury from the piloting tip, stay clear of vessels, nerves, bowel and viscera when entering the surgical site, manipulating tissue and fixating mesh. After use, the SorbaFix™ Absorbable Fixation System may be a potential biohazard. This device has a piloting tip, which should be considered a sharp even when the device is not actuated. Handle and dispose of in accordance with any local and federal laws regarding medical waste and sharps disposal requirements to prevent sharps injuries.

Adverse Reactions

Adverse reactions and potential complications associated with fixation devices such as the SorbaFix™ Absorbable Fixation System may include, but are not limited to the following: hemorrhage; pain, edema and erythema at wound site; allergic reaction to Poly (D, L)-lactide; septicemia/infection; hernia recurrence/wound dehiscence.

Please consult package insert for more detailed safety information and instructions for use.

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