NuVasive, Inc. recently announced that the company received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of the Precice internal limb lengthening solution in pediatric patients.
NuVasive is a leader in the field of spine technology, and has developed minimally disruptive solutions for spine surgery.
Limb lengthening surgery is performed to reduce or correct discrepancies in limb lengths by increasing the length of a bone in the arm or leg, while simultaneously stretching any surrounding muscles, tendons and ligaments. Limb length discrepancies (LLD) can range from a fraction of an inch to several inches and may be congenital or caused by fractures that did not heal properly, bone tumors or bone cysts.
The surgery is a lengthy and physically demanding one, but the Precice system simplifies the process due to its patented technology that allows for constant changes from the time of implantation throughout the course of treatment. This accommodates the clinical needs of pediatric patients, especially since they are still growing.
Pete Ligotti, leader of NuVasive Specialized Orthopedics (NSO, a division of NuVasive), mentions in the press release that Precice “accommodates the changing clinical needs of patients as they heal, grow and age, reducing the need for further surgeries throughout treatment.”
John Herzenberg, the director of pediatric orthopedics at Sinai Hospital in Baltimore, Maryland, adds that the “new indication is significant for my practice as the majority of my patients are under the age of 18, and it provides me with the assurance I need to offer Precice as a pediatric LLD solution.”
About NuVasive’s Precice System
The Precice Intramedullary Limb Lengthening System is a unique, proprietary solution for limb lengthening surgery. It is developed with magnetically adjustable technology that allows for the implant to be lengthened non-invasively via an external remote, precisely lengthening bones in the process.
Precice follows the method of distraction osteogenesis, which is making a longer bone out of a shorter one. Once a bone is cut during the surgery, the distractor (Precice implant) pulls the two pieces of bone apart slowly by being lengthened based on the patient’s needs with the handheld remote.
There are numerous benefits to this surgical option. For example, cost savings for patients treated with Precice compared to other surgical techniques (external lengthening over an implanted nail), simplified surgical application because the same techniques are used as when implanting a conventional trauma rod, and intraoperative and postoperative customization in lengthening prescription by the physician.
An internal method like Precice also offers solutions to problems associated with external fixation options, such as soft tissue scarring, muscle tethering and inflammation or infection due to wires and pins.
Since 2011, the Precice implant has been used to treat more than 15,000 patients in about 50 countries, and the implant has over ten years of clinical data supporting its use. Its implementation has changed the standard of care for many.
The Growth of Musculoskeletal Solutions
In February 2023, NuVasive was acquired by Globus Medical, a musculoskeletal solutions company, in an all-stock transaction valued at approximately $3.1 billion. Globus Medical shareholders will hold the majority of the stake at 72 percent, while NuVasive shareholders hold the remaining 28 percent.
NuVasive CEO Chris Barry stated in the news release that “Together, we will be able to offer an exceptional portfolio of clinically proven solutions, supported by strong commercial and surgeon education teams.”
The acquisition is expected to increase both companies’ globalization strategies in targeting the musculoskeletal market valued at $50 billion, with major competitors including Medtronic, Stryker and Zimmer Biomet.
Additionally, the NSO division of NuVasive plans to further NuVasive’s orthopedic innovations. The group is focused on designing and innovating disruptive orthopedic solutions for orthopedic reconstruction and limb lengthening. Their next area of focus is intelligent surgery including next-generation motorized technology for dynamic orthopedic implants.