Healthcare Industry News: Fixation System
News Release - October 12, 2010
Covidien Announces New Evidence That Underscores Clinical Value of Hernia and Abdominal Wall Repair Products
Surgeons present preliminary results on two pioneering clinical trials for hernia repair at 32nd International Congress of the European Hernia SocietyISTANBUL--(Healthcare Sales & Marketing Network)-- Covidien (NYSE:COV ), a leading global provider of healthcare products, announced that its hernia and abdominal wall repair products were featured in 18 podium presentations at the 32nd International Congress of the European Hernia Society (EHS). Highlights included results from multicenter studies demonstrating that Covidien products may play an increasingly important role in reducing postoperative pain and complications in open and laparoscopic hernia and abdominal wall repair procedures.
“We had a strong presence at this year’s EHS Meeting,” said Scott Herring, President EMEA Surgical Devices, Covidien. “The clinical presentations demonstrated Covidien’s commitment to deliver innovative products that offer proven benefits and value to surgeons, patients and payors.”
Surgeons presented data from three multicenter clinical trials sponsored by Covidien. The data included preliminary results on two prospective randomized studies comparing Covidien Parietex ProGrip™ mesh and AbsorbaTack™ absorbable fixation device to their respective standards of care.
According to preliminary multicenter study data presented at EHS, use of Parietex ProGrip mesh reduced pain compared with the gold standard sutured mesh repair at all time points measured from discharge to three months postoperatively.1 Pain was significantly reduced at discharge and day seven. Results of the study also show that use of Parietex ProGrip Mesh significantly shortened the surgery duration and reduced infection rate.
“By eliminating the need for abdominal wall sutures, Parietex ProGrip mesh makes hernia repair simple and fast, providing better outcomes for patients compared with the gold-standard Lichtenstein model,” said principal investigator Prof. Andrew Norman Kingsnorth, Professor of Surgery at Derriford Hospital, Plymouth, U.K. “We look forward to seeing additional data, including the final results of the study, to confirm these promising results.”
In the second randomized study, preliminary results from ten sites showed that the Covidien AbsorbaTack absorbable fixation device demonstrated a significant reduction in VAS pain scores compared with permanent fixation at one month follow-up after inguinal hernia repair.2
In the third multicenter clinical trial on Parietex composite mesh to treat giant incisional hernias, investigators reported a low recurrence rate (7% at two years) related to the device given the complexity of the indication.3 These findings support the use of an intraperitoneal polyester protected mesh as a relevant and safe solution for the long-term treatment of complex incisional hernias.
In addition, independent surgeons presented new data supporting the adoption of:
- Parietex ProGrip self-fixating mesh in open and transabdominal pre-peritoneal inguinal hernia procedures and open ventral hernia repair
- AbsorbaTack absorbable mesh Fixation System in laparoscopic inguinal hernia repair
- Permacol™ biologic implant in open incisional hernia repair
Covidien highlighted products include:
Parietex ProGrip Self-fixating Mesh - Designed for ease of use, resorbable polylactic acid (PLA) microgrips enable surgeons to position and securely place the mesh in under 60 seconds without the use of additional fixation. Tension is evenly distributed for patient comfort.
AbsorbaTack Fixation Device – A sterile, single-use device designed for fixation of prosthetic material, such as hernia mesh, to soft tissues in laparoscopic abdominal wall surgeries and open hernia repair. The tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid.
Permacol Biologic Implant - The porcine dermal collagen implant gently removes cells, cell debris, DNA and RNA without damaging the 3D collagen matrix. The resulting acellular collagen matrix is then cross-linked for enhanced durability throughout the wound healing process in complex abdominal wall and hernia repairs.
References
1 Kingsnorth, A., Preliminary Results Of A Comparative Randomized Study: Benefit Of Self-Gripping Parietex Progrip™ Mesh In Open Inguinal Hernia Repair, 32nd International Congress of the European Hernia Society, October 7, 2010, Istanbul, Turkey, Abstract SFP-1. Data on file.
2 Rosen M, Post-Operative Pain After Laparoscopic Inguinal Hernia Repair: AbsorbaTack™ Vs. ProTack™. Interim Results from A Prospective Randomized Study, 32nd International Congress of the European Hernia Society, October 7, 2010, Istanbul, Turkey, Abstract OP-23. Data on file.
3 Arnaud JP, Giant Incisional Hernia Treatment Using Parietex™ "Composite” Mesh, 32nd International Congress of the European Hernia Society, October 8, 2010, Istanbul, Turkey, Abstract OP-60. Data on file.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2009 revenue of $10.3 billion, Covidien has 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
Source: Covidien
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