NuVasive Inc. (NSDQ:NUVA) said today that it won FDA 510(k) clearance and CE Mark clearance in the European Union for its Precice bone transport system.
The San Diego, Calif.-based company touted the system as the only all-internal system indicated for use in segmental bone loss treatment in the tibia and femur resulting from trauma or infection.
The Precice bone transport system includes an implantable magnetic intramedullary nail with a dual slot intended to support the transport of an intercalary bone segment to allow for health regeneration, NuVasive said. Following implantation, an external remote control is used to move the bone segment up to 10 centimeters based on patient needs, the company added.
The newly cleared all-internal system does not require patients to wear an external device for an extended period of time, reducing the potential for increased pain and risk of infection, NuVasive said.
“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. 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,” Dr. J. Watson of the University of Arizona College of Medicine said in a press release.
NuVasive said that it plans to launch the system commercially in the U.S. and Europe in the third quarter of this year.
“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. 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,” NuVasive Specialized Orthopedics president Massimo Calafiore said in a prepared statement.
Earlier this month, a report emerged suggesting that Smith & Nephew (NYSE:SNN) is in discussions to pick NuVasive in a deal that could be worth more than $3 billion.
