DUBLIN, Ireland--(BUSINESS WIRE)--Covidien plc (NYSE:COV) today announced the launch of ReliaTack™ articulating reloadable fixation device, the first and only of its kind for laparoscopic (minimally invasive) hernia repair.‡
By offering 65-degree articulation, the ReliaTack™ device provides surgeons with greater access to weak spots within the abdominal wall, enabling them to more securely tack mesh into place.£,1 The system’s unique screw-like tacks provide twice the strength of other fixation devices†,2 and come in interchangeable five- and 10-tack reload sets.3
“Developed with valuable input from surgeons, the ReliaTack™ device, combined with our recently-launched Symbotex™ composite mesh, benefits patients while helping drive greater operating room efficiency and economic benefits,” said Rob Claypoole, vice president and general manager, Hernia, Covidien. “The ReliaTack™ fixation device overcomes numerous physical and ergonomic challenges in ventral hernia repair by allowing a wide variety of angles to more effectively position and secure hernia mesh.”
Non-articulating fixation devices traditionally have presented several challenges in laparoscopic ventral hernia repair. Compared to using the ReliaTack device, utilizing a non-articulating model can mean more difficulty accessing mesh fixation sites, less fixation strength, and an increase in cost when more than one device must be used in a single procedure.4,5,6
“Covidien’s proven tack design helps surgeons ensure that the mesh will stay in place, one of the key concerns of hernia repair surgery. By offering interchangeable tack reload sets, ReliaTack™ helps to eliminate much of the waste associated with non-articulating devices,” said Matt Cohen, vice president, Research & Development, Covidien.
Surgeons have performed millions of procedures using Covidien’s fixation devices over the last 20 years.7 The ReliaTack™ device received FDA 510(K) clearance in April 2014.
The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) estimate that approximately 90,000 ventral hernia repair procedures are performed each year in the U.S. A ventral hernia usually occurs due to a weakness of the abdominal wall caused by a previous surgical incision. The intestines or other abdominal contents can push into a sac and may cause them to get stuck resulting in potential complications and requiring emergency surgery.
Covidien is a global health care leader that understands the challenges faced by providers and their patients and works to address them with innovative medical technology solutions and patient care products. Inspired by patients and caregivers, Covidien’s team of dedicated professionals is privileged to help save and improve lives around the world. With more than 38,000 employees, Covidien operates in 150-plus countries and had 2013 revenue of $10.2 billion. To learn more about our business visit www.covidien.com or connect with us on Twitter.
‡ Compared to commercially available absorbable fixation devices
£ In comparison to AbsorbaTackTM fixation device
† Compared to Absorbable Fixation Devices, SecureStrapTM* device and SorbafixTM* device, when the shaft is angled at 30, 45, and 60 degrees
§ Per case savings over SecureStrapTM* device and SorbafixTM* device per case savings when 30-60 tacks are needed
1 Mesh Overlap Claims Testing Report R0054140 P-Value = 0.007 (March 2014). Data obtained in simulated lab.
2 ReliaTackTM device Perpendicular Tack Deployment and Shear Pull Test Report R0048913 P-value = 0.00 (March 2014). Data obtained in simulated lab.
3 ReliaTackTM device Cost Comparison, IMS Data Compares ReliaTackTM device Total Cost to SecureStrapTM* device and SorbaFixTM* device when 30-60 Tacks are needed
4 ReliaTack™ device Validation Report: Evaluation in Simulated Use with Surgeons and Nurses R0057955 (June 2014).
5 Engineering Development of Reliability Testing Report #2165-037-0 (March 2014).
6 Clinical Literature Review. Mesh overlap and risk of recurrence in ventral hernia mesh repair (Jan 2012).
7Since 2010 according to Global Cognos data
COVIDIEN, COVIDIEN with logo, COVIDIEN logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. ™* Trademark of its respective owner. Other brands are trademarks of a Covidien company. ©2014 Covidien. 10.14 US140634