A Medical Device Daily
Core Essence Orthopaedics (Yardley, Pennsylvania), a company focused on soft tissue and skeletal repair of the extremities, said it has received FDA 510(k) clearance for Securus, a knotless suture anchor system used in minimally invasive, arthroscopic surgery.
According to the company, Securus provides increased flexibility, simplicity, and ease for surgeons seeking to employ minimally invasive techniques in the surgical treatment of rotator cuff repair.
Shawn Huxel, co-founder/CEO of Core Essence, calls the device a "game-changing product" in the area of rotator cuff repair. "In the U.S., rotator cuff repair represents a $600 million device market opportunity, a market that continues to increase as the population ages. And yet today, only a small fraction of shoulder tendon repairs are performed using the less invasive arthroscopic surgical approach the approach preferred by most patients because surgeons have been dissatisfied with the tools available for these less invasive procedures," He said.
According to Core Essence, Securus is designed to give surgeons the motivation to make the transition to minimally invasive surgery at the precise time when the demand for arthroscopic surgery is more significant than ever. The 510(k) clearance means Core Essence will be on track to ramp up distribution over the course of 2009, the company noted.
Securus is an implantable platform system that locks down sutures in arthroscopic tendon repair surgeries, particularly high volume shoulder procedures focusing on rotator cuff repair. The product is available in 5.5 mm and 7.0 mm diameters to address varying degrees of bone quality, as well as rescue potential, the company said.
Core Essence is not alone in developing knotless suture anchors for rotator cuff repair. Among its competitors is DePuy Mitek (Raynham, Massachusetts), which in 2007 launched its Lupine BR and Bioknotless BR, the first suture anchors made from its biocryl rapide biocomposite material (Medical Device Daily, Sept. 11, 2007). The Lupine BR and Bioknotless BR anchors offer both traditional and knotless suture anchor options for surgical attachment of soft tissue to bone during arthroscopic shoulder instability repair, according to DePuy.
However, Core Essence says its Securus system presents several advantages to alternatives currently available on the market, including: consistent, reproducible bone and suture retention strength, tactile tensioning of sutures (allowing the surgeon to "feel" the tension in the soft tissue prior to locking the anchor), and a readily revisable implant system. Unlike most current knotless anchors, Securus can be adjusted intraoperatively and even removed and replaced, Core Essence said.
"I was extremely intrigued when I first learned about Securus," said Andrew Rokito, MD, chief of the Ddivision of shoulder and elbow surgery at the New York University Hospital for Joint Diseases and a member of Core Essence's scientific advisory board. "Because of its unique, intuitive, tactile feel, Securus is ideal for surgeons who currently prefer to perform open surgeries due to a lack of effective surgical tools designed for arthroscopic use. I am convinced Securus will encourage surgeons to perform more rotator cuff procedures arthroscopically due to its simple and elegant features."
In addition to Securus, Core Essence has recently launched orthopedic product platforms including Seg-Way, a synchronized endoscopic guide system for carpel tunnel syndrome; reNOVO, a suture anchor system, and reVERTO, a shape memory staple system indicated for arthrodesis and skeletal fixation procedures.