FREEDOM PROFLOR™

INGUINAL HERNIA REPAIR SYSTEM

FREEDOM PROFLOR - designed for fixation-free inguinal hernia repair.

The Freedom ProFlor Inguinal Hernia Repair System, designed for open, fixation-free inguinal hernia repair, is comprised of a large porous polypropylene implant and a unique delivery device.

CORE

Occupies The Defect

PREPERITONEAL DISK

  • CORE

    Occupies The Defect
  • PREPERITONEAL DISK

Existing Clinical Problem

Acute and chronic post-operative pain has been associated with open inguinal hernia repair, with Reinpold et al reporting a 16.5% incidence of chronic pain 6 months after surgical repair(1). Point fixation and onlay meshes are the main causes for chronic pain after open inguinal hernia repair surgeries

1. Reinpold WMJ, Nehls J, Eggert A. Nerve management and chronic pain after open inguinal hernia repair. Ann Surg. 2011; 254:163–168. [PubMed]

The Freedom ProFlor Solution

Dynamic Core

The combination of the dynamic core and the posterior disk is designed to provide fixation-free placement, allowing regrowth of healthy tissue.

No Onlay Component, No Stitching

Less invasion of the anterior space reduces the risk of nerve damage, shrinkage and therefore the most common factors contributing to chronic pain.

Healthy Tissue In-growth

PORCINE HISTOLOGY RESULTS AT 8 MONTHS

healthy connective tissue

well-structured arteries

mature nerve structure

Amato G. et al. A New Prosthetic Implant for Inguinal Hernia Repair: Its features in a Porcine Experimental Model. Artif Organs, 35(8):E181 E190 (2011)

Confidence in Outcomes

Over 375 patients in 11 clinical studies and 5 case series since 2009^

Randomized, controlled trial to evaluate immediate post-op pain following Freedom ProFlor and Lichtenstein open inguinal hernia repair5

The Freedom ProFlor Group showed

  • 43% reduction in Operative Time*
  • 6x reduction in post-op analgesics*
  • Significantly less pain at POD 7* (VAS)
  • Significantly improved Quality of Life* (CCSTM)

TRIAL RESULTS: POST-OP PAIN AND QoL5

^Data on file | *Statistically significant (p<0.01)
PAIN ASSESSMENT ON VISUAL ANALOG SCALE (VAS)
PAIN ASSESSMENT ON CAROLINAS COMFORT SCALE

Direct Inguinal Hernia Repair

1. Open the transversalis fascia and create a preperitoneal pocket for the disk.

2. Insert Freedom ProFlor into the defect and deploy the disk in the preperitoneal space.

3. Position the transversalis fascia around the perimeter of the core.

Indirect Inguinal Hernia Repair

1.Dissect the indirect hernia sac completely free from the cord structures and the internal ring. Create a preperitoneal pocket for the disk.

2. Insert Freedom ProFlor through the internal ring and deploy the disk in the preperitoneal space.

3. Position the transversalis fascia around the perimeter of the core. Adjust the petals to accommodate the cord structures.

REFERENCES

  • George S. Ferzli, Eric Edwards, Georges Al-Khoury, RoseMarie Hardin. Postherniorrhaphy Groin Pain and How to Avoid It. Surgical Clinics of North America, Volume 88, Issue 1, February 2008, Pages 203-216. ISSN 0039-6109, http://dx.dol.org/10.1016/j.suc.2007.10.006.
  • Kim-Fuchs C, Angst E, Vorburger S, Helbling C, Candinas D, Schlumpf R. Prospective randomized trial comparing sutured with sutureless mesh fixation for Lichtenstein hernia repair: long-term results. Hernia. 2012 Feb;16(1):21-7. doi: 10.1007/s10029-011-0856-3. Epub 2011 Jul 26.
  • Willaert W, De Bacquer D, Rogiers X, Troisi R, Berrevoet F. Open Preperitoneal Techniques versus Lichtenstein Repair for elective Inguinal Hernias. Cochrane Database of Systematic Reviews 2012, Issue 7. Art. No.: CD008034. doi: 10.1002/14651858.CD008034.pub2.
  • Amato G. et al. A New Prosthetic Implant for Inguinal Hernia Repair: It’s features in a Porcine Experimental Model. Artif Organs, 35(8):E181–E190 (2011)
  • Murphy J. et al. A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair. Hernia (2014) 18 (Suppl 1): S45-S46

Freedom ProFlor downloads

Freedom Octomesh

Freedom Ventral Hernia Repair. No Sutures. No Tacks.

Freedom ProFlor

Hernia Repair From Tension-free to Fixation-free

Ultra 7Fr IAB

The world’s only true 7FR IAB catheter Full 8FR performance in a 7FR catheter

Double Pump RF

detects factors that impede visibility during surgery, and automatically adjusts for them.

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Insightra Medical, Inc.
141 Hatcher Ln
Clarksville, TN 37043

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