EXISTING CLINICAL PROBLEM

For a long time inguinal hernia repair has seen little invention, taking into account the root cause of inguinal hernias.

Recent studies(1-7) demonstrated the degenerative character of the disease, identifying the weakening of the inguinal floor caused by chronic compressive force, leading to groin degeneration.

The numerous postoperative complications associated with open inguinal hernia repair, most importantly the high incidence rate of acute and chronic post-operative pain caused by point fixation and onlay meshes, with recent studies reporting a 16.5% incidence of chronic pain 6 months after surgical repair(8), demand a new approach.

THE FREEDOM PROFLOR SOLUTION

A SIGNIFICANT CONCEPT CHANGE

More than a decade of research has led to the invention of the ProFlor Dynamic Hernia Implant. Static mesh repair stands in direct contrast to repairing a muscular defect in the most mobile area of the human body.

ProFlor’s combination of the dynamic core and the posterior disk is designed to provide fixation-free placement and responsive movement with the surrounding muscles, allowing regrowth of healthy muscle tissue thereby restoring the inguinal barrier.

NO ONLAY COMPONENT, NO STITCHING

ProFlor anchors itself in the defect, obliterating the hernia defect and leaves the anterior space unaffected. This eliminates the risk of anterior nerve damage, shrinkage and therefore the most common factors contributing to chronic pain.

HEALTHY TISSUE IN-GROWTH

HUMAN HISTOLOGY RESULTS AT 8 MONTHS*

Proflor Implant Fully Occupied By Flesh Tissue

25 mm ProFlor cut in half - Removed from pig 6 months after implantation

HEALTHY MUSCLE TISSUE

WELL-STRUCTURED ARTERIES

MATURE NERVE STRUCTURE

*Biologic Response of Inguinal Hernia Prosthetics: A Comparative Study of Conventional Static Meshes Versus 3D Dynamic Implants with delivery kit Artificial Organs. 2015 Jan;39(1):E10-23

Confidence in Outcomes

Randomized, controlled trial to evaluate immediate post-op pain following Freedom ProFlor and Lichtenstein open inguinal hernia repair 9

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

PAIN ASSESSMENT ON VISUAL ANALOG SCALE (VAS)

INDIRECT INGUINAL HERNIA REPAIR

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 interfacing the edge of the implant.

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 implant edges interfacing the internal ring. Adjust the petals to accommodate the cord structures.
†Procedural summary only. Refer to ProFlor Instructions for Use for step-by-step guidance on the complete procedural sequence.

REFERENCES

  • 1. Amato G, Marasa L, Sciacchitano T, Bell SG, Romano G, Gioviale MC, Lo Monte AI, Romano M. (2009) Histological findings of the internal inguinal ring in patients having indirect inguinal hernia. Hernia 13;259-62
  • 2. Amato G, Ober E, Romano G, Salamone G, Agrusa A, Gulotta G, Bussani R. (2011) Nerve degeneration in inguinal hernia specimens. Hernia 15:53-58
  • 3. Amato G, Romano G, Salamone G, Agrusa A, Saladino VA, Silvestri F, Bussani R. (2012) Damage to the vascular structures in inguinal hernia specimens. Hernia 16:63–67
  • 4. Amato G., Agrusa A., Romano G. ,Salamone G., Gulotta G., Silvestri F., Bussani R. (2012) Muscle degeneration in inguinal hernia specimens. Hernia 16(3):327-31
  • 5. Amato G, Agrusa A, Romano G, Salamone G, Cocorullo G, Mularo SA, Marasa S, Gulotta G. (2013) Histological findings in direct inguinal hernia. Hernia 17(6):757-63
  • 6. Amato G., Agrusa A., Rodolico V., Puleio R., Di Buono G., Amodeo S., Gulotta E., Romano G. (2016) Combined inguinal hernia in the elderly. Portraying the progression of hernia disease Int J Surg. Suppl 1:S20-9
  • 7. Amato G, Calò P, Rodolico V, Puleio R, Agrusa A, Gulotta L, Gordini L, Romano G. (2018) The Septum Inguinalis: A Clue to Hernia Genesis? J Invest Surg. Oct 31:1-9.
  • 8. Reinpold WMJ, Nehls J, Eggert A. Nerve management and chronic pain after open inguinal hernia repair. Ann Surg. 2011; 254:163–168. [PubMed]
  • 9. Murphy JW, Porwal A (2016) Comparison of Lichtenstein and Proflor™ Open Inguinal Hernia Repair in Regards to Immediate Post-Op Pain: A Randomized Double Blinded Registered Clinical Study. J Surg Transplant Sci 4(5): 1040.

ASSUT EUROPE S.p.A.

assuteurope.com

info@assuteurope.com

Via G. Gregoraci, n.12
00173 Roma
Tel. +39 06 72677348
Fax +39 06 72675380

Italy
UK
Brazil

INSIGHTRA MEDICAL INC.

insightra.com

info@insightra.com

141 Hatcher Lane
Clarksville TN 37043 USA
Tel. (888) 709-5939
Fax (931) 919-2953

USA
Portugal
Spain
Iran
Saudi Arabia
United Arab Emirates
India

BIOCER ENTWICKLUNGS-GMBH

biocer-gmbh.de

info@biocer-gmbh.de

Ludwig-Thoma-Str. 36c
95447 Bayreuth, Germany
Tel. +49 (0)921 78 77 70 0
Fax. +49 (0)921 78 77 70 79

Germany
Austria
Switzerland
©2019 Hernia Alliance | All RIghts Reserved | Site by Clarksville Website Design