Company receives FDA 510(k) clearance and CE mark approval for use of minimally invasive Precice® Bone Transport System to treat segmental bone defects up to 10 centimeters in the tibia and femur
SAN DIEGO – Feb. 19, 2019 – NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) – as well as European CE mark approval – for use of its Precice® Bone Transport System, the only all-internal system of its kind on the market indicated for use in segmental bone loss treatment in the tibia and femur resulting from trauma or infection. The Precice Bone Transport System joins the NuVasive Specialized Orthopedics™ (NSO) family of advanced, magnetically adjustable limb-lengthening products which have collectively been used to treat thousands of patients. NSO is a division of NuVasive, focused on the design and innovation of disruptive orthopedic solutions, including its proprietary platform of magnetically adjustable implant systems.
“The Precice Bone Transport System enables the treatment of complex segmental defects using the proven, less invasive, Precice magnetic technology which is a game-changer for my practice and patients,” said Dr. J. Tracy Watson, professor of orthopedic surgery, University of Arizona College of Medicine – Phoenix, and the CORE Institute. “Patients who undergo a bone transport procedure due to trauma, tumors or infection are already dealing with significant issues regarding their condition, and the extreme time commitment it takes to reconstruct these significant bone defects. To be able to offer a treatment option that allows them to avoid many of the traditional complications and physical challenges of dealing with an external fixation system that is on their limb for an extended period of time is a significant development.”
The Precice Bone Transport System includes an implantable, magnetic intramedullary nail with a dual slot designed to support the transport of an intercalary bone segment to facilitate healthy regeneration. Following implantation, an external remote controller is used to precisely move the bone segment up to 10 centimeters based on the specific needs of each patient. The Precice Bone Transport System provides an all-internal solution compared to traditional external fixation systems which require patients to wear an external device for an extended period of time, with the potential for increased pain and risk of infection.
Indications for the Precice Bone Transport System include treatment of acute bone defects up to 10 centimeters. The stainless steel device provides the strength and stability needed to treat more complex segmental defects due to trauma or infection including, but not limited to, infected non-unions, segmental defect and chronic bone infections. The bone transport device uses proven Precice magnetic technology which is also used in the Precice Stryde™ System, an intramedullary limb-lengthening system cleared by the FDA and CE marked in 2018 for limb lengthening of the femur and tibia.
“The FDA clearance and CE mark approval for use of the Precice Bone Transport System are an exciting step forward for NSO as we continue to demonstrate how our innovative technologies can transform the orthopedic trauma space. With this clearance, we are now able to offer surgeons an all-internal, reliable treatment option that provides a simple approach to salvage both limbs and joints for complex limb reconstructions, such as patients with invasive tumors or large segmental defects,” said Massimo Calafiore, president of NSO. “We remain committed to the ongoing development of innovative orthopedic solutions that equip surgeons to fulfill unmet clinical needs and, ultimately, improve the lives of patients.”
The Precice Bone Transport System is expected to launch commercially in the U.S. and Europe in third quarter 2019.
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400-person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.