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News Release - October 12, 2017
NuVasive Receives Expanded FDA 510(k) Clearance For Innovative Magnetic Limb Lengthening TechnologyNew Additional Clearance for the Company's PRECICE® system includes fracture fixation, pseudoarthrosis, malunions, nonunions and bone transport
SAN DIEGO, Oct. 12, 2017 -- (Healthcare Sales & Marketing Network) -- NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received expanded 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company's PRECICE® system from NuVasive Specialized Orthopedics™ (NSO) with expanded indications that now include open and closed fracture fixation, pseudoarthrosis, malunions, nonunions, and bone transport.
The PRECICE system is an innovative, market-leading solution to treat patients with limb length discrepancy, limb deformities and chronic nonunions. The platform consists of an intramedullary device that once implanted utilizes an external remote controller to non-invasively compress and distract long bones. The key to the PRECICE platform is the magnetic interaction between the PRECICE intramedullary nail and external remote control. The proprietary technology includes a complex internal gear system remotely activated and controlled by permanent magnets. This advancement in limb reconstruction allows for a precision controlled distraction phase with the ability to non-invasively customize treatment.
Prior to the expanded FDA clearance, the PRECICE system was indicated for limb lengthening of the femur and tibia. The system is now indicated for bone transport of long bones in addition to limb lengthening. Bone transport is a technique that allows for regeneration of bony tissue and is typically used to fill segmental bone loss due to trauma or infection, i.e. infected nonunions, segmental defect, and chronic bone infections. The expanded indications for use allows the Company to continue to build a platform for further growth in the limb reconstruction and trauma markets.
"This FDA 510(k) clearance of PRECICE for expanded indications, including bone transport, demonstrates the evolving innovative capabilities of our technology to transform and expand the limb reconstruction and trauma markets," said Massimo Calafiore, president of NSO. "NSO remains committed to providing trauma surgeons with proper solutions to treat unmet clinical needs and challenging fractures. This allows us to treat more patients suffering from debilitating segmental bone defects through the use of PRECICE in bone transport procedures."
The Company has also created a patient and family online resource dedicated to providing information on limb length discrepancy with Reach Your Height. The digital resource center provides education on treatment options and shares patient success stories. To learn more, visit reachyourheight.com.
NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, 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 $962 million in revenues (2016), NuVasive has an approximate 2,300 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.
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