Smith & Nephew Receives Multiple Clearances for Suture Devices

Smith & Nephew plc has received U.S. Food and Drug Administration (FDA) clearance to expand indications within the hip for the Healicoil PK Suture Anchor and Osteoraptor Suture Anchor. Indications for the Healicoil have been expanded to include abductor repair while those for the Osteoraptor now include labral reconstruction.

“Hip arthroscopy is not only one of the newest and most exciting frontiers in sports medicine, it’s an area we’ve proudly helped to pioneer,” said Alain Tranchemontagne, senior vice president within Smith & Nephew’s Advanced Surgical Devices Division. “By bringing first-to-market devices such as the Healicoil PK Suture Anchor and the Osteoraptor Suture Anchor to these emerging techniques, we further strengthen our position as the innovation leaders in hip arthroscopy.”

Healicoil PK Suture Anchor “is a truly unique suture anchor and is ideal for abductor repair,” explained J.W. Thomas Byrd, M.D., of Nashville, Tenn. “Besides being easily inserted into both hard and osteoporotic bone, it leaves behind a minimal amount of material.”

Often referred to as the “rotator cuff of the hip,” tears of the hip abductor tendon are a common cause of lateral hip pain. In fact, estimates show that nearly 25 percent of middle-aged women and 10 percent of middle-aged men will develop a tear of the gluteus medius tendon. The Healicoil PK Suture Anchor was launched earlier this year for use in shoulder repair. It features a unique open-architecture design that uses less material than traditional, solid-core anchors while reportedly providing significantly more thread engagement and greater pullout strength than its competitors.

Also cleared for use by the FDA for abductor repair are the Twinfix Ultra and Footprint Ultra Suture Anchors. This gives Smith & Nephew a full range of anchor constructs, materials, sizes and suture configurations for either double or single row fixation techniques.

With the Osteoraptor Suture Anchor, surgeons now have an FDA-cleared device and technique for reconstructing a torn or detached labrum. Labral tears in the hip, often associated with a traumatic injury like dislocation, can be a source of chronic hip pain and may even contribute to the development of osteoarthritis. A hip labral tear involves the ring of soft elastic tissue, called the labrum, that follows the outside rim of the socket of the hip joint. The labrum acts like a socket to hold the ball at the top of the thigh bone (femur) in place.

In standard labral repair, the labrum is reattached to the bony socket of the joint using small anchors and sutures. Hip surgeon Marc J Philippon, M.D., of the Steadman Philippon Research Institute in Vail, Colo., has pioneered a procedure to reconstruct the soft tissue in cases when the labrum is too degenerated to be repaired, using the naturally bioabsorbable Osteoraptor Suture Anchor.

“The Osteoraptor has always been my gold standard for hip labral repairs, and now I trust it to deliver the same reliable fixation when doing a reconstruction procedure,” said Philippon.

The Osteoraptor Suture Anchor measures 2.3 mm. Smith & Nephew claims the anchor allows surgeons to use multiple anchors in a small joint space for a precise and secure repair. These naturally biocompatible suture anchors are made of hydroxyapapatite, a calcium phosphate similar to the mineral found in bone. Also cleared by the FDA for this procedure are the Bioraptor Suture Anchor and Bioraptor Knotless Suture Anchor.

Smith & Nephew provides medical technology in the orthopedic reconstruction, advanced wound management, and sports medicine and trauma spaces. The company’s global headquarters are in London, United Kingdom, and its U.S. offices are located in Andover, Mass., and Memphis, Tenn.

Photo of Healicoil PKSuture Anchor courtesy of Smith & Nephew.