Smith & Nephew Launches HEALICOIL REGENESORB in U.S.

Smith & Nephew has just kicked off the U.S. launch of the HEALICOIL REGENESORB Suture Anchor. The company indicates that this new suture anchor is the first device to use the company’s proprietary REGENESORB material, an advanced biocomposite that has been shown in pre-clinical studies to be absorbed and replaced by bone within 24 months. The HEALICOIL REGENESORB Suture Anchor was designed primarily for shoulder rotator cuff repair, but is also indicated for use in the knee, elbow, foot and ankle.

“The HEALICOIL REGENESORB Suture Anchor is a perfect marriage of implant design and material, ” says orthopedic surgeon, Scott Trenhaile, clinical assistant professor of surgery, University of Illinois College of Medicine at Rockford, in the November 7, 2013 news release. “Within this one implant, I get the bone ingrowth and mechanical strengths of the original HEALICOIL, as well as the bioabsorption advantages that come from gradually transferring the stresses to the healing bone as the anchor is steadily absorbed.”

All HEALICOIL Suture Anchors use a unique, open-architecture design that eliminates the inner diameter material found in traditional, solid-core anchors. Pre-clinical testing has demonstrated that this design allows for new bone to fill the spaces between the threads and within the central channel by 12-weeks after implantation. In addition, the extended, fully-threaded HEALICOIL REGENESORB anchor design was shown in biomechanical testing to provide more threaded engagement than other biocomposite anchors; delivering greater pullout strength in poor-quality, osteoporotic bone. Additionally, the HEALICOIL inserter engages nearly 100% of the anchor’s length, which minimizes stress and provides predictable insertion into hard bone by distributing torque along the entire length of the anchor.

“When we introduced the HEALICOIL PK Suture Anchor, its design set a new standard for innovation in our industry, ” says Brad Cannon, president, Endoscopy, Trauma and Extremities for Smith & Nephew. “With HEALICOIL REGENESORB, we combined the benefits of that design with an advanced material to raise the standard even higher.”

The rotator cuff, which is made up of a group of four muscles whose tendons converge to help stabilize and move the shoulder, is subject to a considerable amount of wear and tear with regular daily activities—especially repetitive overhead motions. Current Smith & Nephew estimates are that over 1 million rotator cuff procedures are performed on an annual basis globally to alleviate persistent pain and help patients regain a full range of motion.

Vivek Munshi, senior market manager at Smith & Nephew, told OTW, “Early in the development process, our Advanced Healing Technologies team looked at previous generations of biocomposite materials and recognized an opportunity to improve the bone healing process by incorporating calcium sulfate alongside REGENESORB’s other well-studied ingredients, PLGA and β-TCP. This unique formulation of safe and proven materials is what sets the REGENESORB platform apart.”

“Of course, designing the right biocomposite material represented only half the challenge. The second challenge was incorporating this material into an existing and well-received implant like the HEALICOIL Suture Anchor. Fundamentally, any suture anchor needs to provide sufficient fixation strength over time and throughout the healing period following the surgical repair. As such, the design and development of the HEALICOIL REGENESORB Suture Anchor was tailored specifically with REGENESORB in mind, all while maintaining the well-accepted open architecture of HEALICOIL PK Suture Anchors. This novel implant design required specialized advanced manufacturing processes in order to strike the optimal balance between mechanical performance and implant absorption rate resulting in the unique and reliable device available today.”