Covidien plc Launches Three New Hernia Care Products at American Hernia Society Annual Meeting
The new hernia care products, featured at the March 13-16 American Hernia Society’s (AHS) annual meeting, are:
• ProGrip™ Laparoscopic Self-Fixating Mesh - Seamlessly combines mesh and fixation into one device to increase the security of laparoscopic inguinal hernia repair?,1,2,3, while eliminating the pain ?,4,5 and reducing the costs associated with tack fixation6,7. The ProGrip laparoscopic mesh provides tack-free fixation over the entire anatomy, including below the inguinal ligament where traditional tacks cannot be placed?,1. ProGrip laparoscopic mesh has been demonstrated to be easier and faster to use than a traditional mesh with standard tacks8,9.
• Parietex™ Composite Ventral Patch - Designed for optimal abdominal wall conformability10 in umbilical and small ventral hernia repair. With a unique design allowing for easy deployment and peripheral fixation10, the Parietex composite ventral patch features a macroporous textile supporting consistent tissue integration and a clinically proven collagen film technology to minimize visceral attachment11.
• AbsorbaTack™ 30X Absorbable Fixation Device - Builds on a foundation of technical innovation in absorbable hernia fixation that began with the launch of the highly successful AbsorbaTack fixation line in 2008. All AbsorbaTack fixation products are designed with patient comfort in mind12, providing strong, temporary mesh fixation13 while leaving no foreign material in the body over time. The new AbsorbaTack 30X fixation device features an enhanced drive mechanism and new shaft for optimal tack deployment in challenging situations.
All three Covidien products received 510(k) clearance from the U.S. Food and Drug Administration and are commercially available.
“Covidien is showing a strong sign of commitment to the hernia market by developing and launching these new products, bringing innovative solutions to answer surgeons’ unmet clinical needs,” said Mark Miller, M.D., F.A.C.S., Medical Director of Surgery, Methodist Le Bonheur Germantown Hospital in Germantown, TN. “I have been pleased with my clinical outcomes while using ProGrip laparoscopic mesh and can’t wait to see how my patients will benefit from Covidien’s future product releases.”
In the U.S., approximately 600,000 inguinal and 700,000 ventral hernia procedures are performed every year, according to industry sources14. A hernia develops when the outer layers of the abdominal wall weaken, bulge or tear, with most hernias resulting from strain on the abdominal muscles. Hernias can grow larger over time and cause serious complications if not surgically repaired.
“We believe product innovations such as ProGrip laparoscopic self-fixating mesh enables less invasive hernia procedures that will result in better patient outcomes,” said Rob Claypoole, Vice President and General Manager, Hernia Care, Covidien. “Even though hernia repair is one of the most frequently performed surgical procedures, there are opportunities to further reduce post-operative pain, improve recurrence rates and facilitate less invasive techniques. As a leader in the market, we are looking forward to the future of hernia care and believe that patients will benefit from these three new products.”
In addition to product demonstrations at AHS booth #307/309, Covidien will host a symposium focused on hernia repair innovation, New Technology Designed To Improve Patient Outcomes, on March 13, 2013 at 12:00pm. The discussion will include intermediate results from a prospective clinical study on self-gripping mesh for laparoscopic Totally ExtraPeritoneal (TEP) inguinal hernia repair. Covidien is also sponsoring a number of presentations at AHS that provide further clinical insights, information and results in advanced hernia care.
1. Kolbe, T, Hollinsky, C, Walter, I, Joachim, A, and Rülicke, T. Influence of a new self-gripping hernia mesh on male fertility in a rat model. Surgical Endoscopy 2010; 24: 455-461
2. PLA grips anatomic characterization for ProGrip™ self-gripping mesh and ProGrip™ laparoscopic self-fixating mesh in a bench study performed by Covidien in June 2012 (Covidien Internal Test Report 0902CR123; data on file)
3. In-vivo pre-clinical study sponsored by Covidien in October 2011 that compared ProGrip™ laparoscopic self-fixating mesh fixation strength to Bard™* soft mesh fixated with Baxter Tisseel™* sealant and Bard SorbaFix™* tacks (Covidien Internal Test Report 0902CR114; data on file)
4. Laxa, B, and Jacob, B. An ongoing prospective study evaluating self-gripping mesh (Parietex ProGrip™) without additional fixation during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: initial analysis. IHS 2012 P1620
5. Birk, D. Self-gripping mesh in laparoscopic inguinal hernia repair. Technique and clinical outcome of 96 operations. IHS 2012 P1654
6. Estimate derived from the use of information under license from the following IMS Health information service: Hospital Supply Index for the period Sep ’06 – Jun ’12. Based on typical prices of anatomical meshes and absorbable fixation in the U.S.
7. Edwards, C. Self-fixating mesh is safe and feasible for laparoscopic inguinal hernia repair. Surgical Endoscopy and Interventional Techniques. Conference: 2011 Scientific Session of the Society of American Gastrointestinal and Endoscopic Surgeons, SAGES San Antonio, TX United States (March 30, 2011 – April 2, 2011). 25: S324
8. When compared to ProGrip™ self-gripping mesh as part of a bench study conducted by Covidien in June 2012 that examined the self-gripping effect of ProGrip™ laparoscopic self-fixating mesh, with and without collagen, as compared to ProGrip™ self-gripping mesh (Covidien Internal Test Report 0902CR122; data on file)
9. Piccini, G, Lissidini, G et al. No tacks, no glue, no frustration during TAPP groin hernia repair with ProGrip™ and V-Loc™ 180. IHS 2012 FP1740
10. Pre-clinical study sponsored by Covidien, in March and June 2012, that evaluated the performance and local tissue effect of the Parietex™ Composite ventral patch in a pig hernia model for ten days and four weeks (Covidien Internal Test Report 0506-141814 incl. Amendment 1; data on file)
11. Pre-clinical study sponsored by Covidien, in January and February 2012, that evaluated the local tissue effects and tissue attachment minimization of a Parietex™ Composite ventral patch in a rat caecal abrasion model (Covidien Internal Test Report 0506-140983 incl. Amendment 1; data on file)
12. Rosen, M, et al. Post-operative pain after laparoscopic inguinal hernia repair: AbsorbaTack™ versus ProTack™ interim results from a prospective randomized study. 32nd international congress of the European Hernia Society, October 7, 2010, Istanbul (study sponsored by Covidien)
13. Hollinsky, C. et al. Tensile strength and adhesion of mesh fixation systems used in laparoscopic incisional hernia repair. Surg Endosc 2010 Jun; 24(6): 1318-24. Epub 2009 Dec 24
14. Truven Health MarketScan® Research Data. Truven Health Analytics. (accessed Feb 26, 2013). ? ProGrip™ laparoscopic self-fixating mesh and ProGrip™ self-gripping mesh have equivalent gripping and mechanical properties2
* Trademarks of respective companies.
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 2012 revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.