NuVasive PRECICE STRYDE™ System Used In First Patient For Stature Lengthening By International Limb Lengthening Expert
SAN DIEGO, May 22, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the new PRECICE STRYDE™ system from NuVasive Specialized Orthopedics™ (NSO) was used in the first set of patients by internationally recognized limb lengthening and reconstruction expert Dr. Dror Paley. Built on five years of clinical experience, PRECICE STRYDE is a market-leading internal system available for stature lengthening and limb reconstruction.
PRECICE STRYDE is NSO’s third-generation limb lengthening system and includes an implantable intramedullary nail, locking screws, reusable instruments and a hand-held External Remote Controller (ERC). STRYDE was recently cleared by the U.S. Food and Drug Administration in April for use in both the tibia and femur. Patients are now able to non-invasively lengthen or shorten the implant to a prescribed length utilizing the ERC post-surgery from their own home versus lengthy hospital stays. When used for stature lengthening for cosmetic purposes, STRYDE can increase a patient’s height by more than three inches.
Dr. Paley is the founder and director of the Paley Orthopedic & Spine Institute in West Palm Beach, Fla., and is recognized as one of the most experienced surgeons in the United States and world in limb lengthening and deformity correction.
“The PRECICE STRYDE technology advances how I am able to treat patients requiring limb reconstruction or those seeking to increase their height, and I am excited to incorporate this into my practice,” said Dr. Paley, a board-certified orthopedic surgeon specializing in limb lengthening and deformity correction. “I continually seek to offer better clinical solutions to my patients, and I am proud to have collaborated with NuVasive in the development of this latest orthopedic advancement.”
This new system aims to provide better and more tolerable post-operative outcomes for patients undergoing limb lengthening. Prior to this technology, a patient was only permitted to apply 30-50 pounds of weight on each leg, leading to a slow and lengthy return to daily life and activities. With STRYDE’s unique stainless steel composition, patients are now able to apply 150-250 pounds of weight on each leg depending on the device chosen and post-operative care recommended by their physician. This offers patients a potential for 200 percent or greater post-operative weight-bearing activity compared to previous systems, and studies have shown earlier weight bearing may lead to quicker healing times in patients using the PRECICE system1. Next launch steps include partnering with leading global limb lengthening surgeons to demonstrate cosmetic stature lengthening viability with plans for a limited launch in mid-2018 and the product more broadly available in 2019.
“At NSO, we are excited to introduce PRECICE STRYDE to the market, which is just the start of a long line of PRECICE products in the next 18-months to further transform the orthopedic space and offer better clinical outcomes for patients,” said Massimo Calafiore, president of NSO. “There is so much opportunity for us to address unmet clinical needs in the orthopedic market—from limb reconstruction to stature lengthening—this latest technology has the ability to drastically improve how our surgeon partners treat their patients.”
About NuVasive
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.
Forward-Looking Statements
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.
1 Laubscher M, Mitchell C, Timms A, et al. Outcomes following femoral lengthening: An initial comparison of the PRECICE intramedullary lengthening nail and the LRS external fixator monorail system. Bone Joint J 2016;98-B:1382–8.
SOURCE NuVasive, Inc.