{"id":58535,"date":"2023-12-06T22:01:19","date_gmt":"2023-12-06T21:01:19","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/ossios-groundbreaking-option-for-fixing-bone-fractures-in-children-receives-fda-clearance\/"},"modified":"2023-12-06T22:01:19","modified_gmt":"2023-12-06T21:01:19","slug":"ossios-groundbreaking-option-for-fixing-bone-fractures-in-children-receives-fda-clearance","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/ossios-groundbreaking-option-for-fixing-bone-fractures-in-children-receives-fda-clearance\/","title":{"rendered":"OSSIO\u2019s Groundbreaking Option for Fixing Bone Fractures In Children Receives FDA Clearance"},"content":{"rendered":"
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\nSupported by Clinical Data Presented at IPOS 2023, Pediatric Indication for OSSIOfiber<\/i>\u00ae<\/sup> Bio-Integrative Orthopedic Fixation Technology Obviates the Need for a Second Surgery to Remove Metal Implants in Young Patients<\/i><\/p>\n

WOBURN, Mass.–(BUSINESS WIRE)–OSSIO<\/a>, Inc., a fast-growing orthopedic fixation technology company, on Friday received \u201cbreaking\u201d news from the U.S. Food and Drug Administration (FDA):<\/p>\n

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\nThe FDA has cleared the company\u2019s OSSIOfiber\u00ae<\/sup> bio-integrative fixation technology for use in orthopedic surgery for children and adolescents needing bone fractures fixed, osteotomies, or fusions. As a result, OSSIOfiber Compression Screws and Trimmable Fixation Nails may now be used in children from age two to 21 years in standard clinical practice.<\/p>\n

\n\u2018Viable and desirable alternative\u2019<\/b><\/p>\n

\n\u201cUsing OSSIOfiber implants in children with bone fractures represents a viable and desirable alternative to implantation of traditional metal pins and screws, which in many situations need to be removed in a second surgical procedure,\u201d explained David Lin, M.D., FAAOS, a leading pediatric orthopedic surgeon who practices at The Pediatric Orthopedic Center<\/a> in northern New Jersey, near New York. \u201cAnother operation creates additional risk of complications while driving incremental healthcare costs, not to mention causing high levels of anxiety among most young patients and their parents.\u201d<\/p>\n

\n\u201cWhen I believe a patient will benefit from an OSSIOfiber implant over a metal one, I\u2019ll offer it,\u201d he added.<\/p>\n

\n\u201cOSSIOfiber implants are strong like metal implants,\u201d Dr. Lin continued, \u201cwith the added advantage of predictably becoming completely incorporated into the patient\u2019s own bone within a reported two years, leaving no permanent foreign material behind. Practically speaking, their appeal is profound: During consultations with injured children and their concerned parents, the mere mention of avoiding a second surgery to repair the same fracture typically elicits an enthusiastically favorable response, as you would expect.\u201d<\/p>\n

\n\u201cLooking ahead,\u201d he concluded, \u201cI predict bio-integrative implants will be the standard solution for orthopedic fixation among most children and adults in the coming years as OSSIO\u2019s offering expands and more people, especially those in the medical community, learn more about it.\u201d<\/p>\n

\n\u2018Evolution of orthopedic surgery\u2019<\/b><\/p>\n

\nMark E. Solomon, DPM, Director of the Pediatric Foot & Ankle Fellowship<\/a> and a partner of Dr. Lin\u2019s at The Pediatric Orthopedic Center, provided his perspective on OSSIO\u2019s innovative fixation technology:<\/p>\n

\n\u201cThe emergence of OSSIOfiber implants a few years ago marks an inflection point in the evolution of orthopedic surgery that my colleagues and I in the United States are keen to incorporate into our practice of what is already a highly evolved surgical subspecialty.<\/p>\n

\n\u201cOn the heels of the technology\u2019s FDA clearance for use in pediatric patients, I\u2019m especially excited for OSSIO this week as the results of a clinical study we conducted of their bio-integrative implants in children treated at our center will be presented at IPOS 2023\u201d \u2013\u2013 this year\u2019s annual meeting of the International Pediatric Orthopedic Society from Dec. 5\u20139 in Orlando, Fla.<\/p>\n

\nThe single-center study, conducted from June 2022 to June 2023 and titled \u201cOrthopedic Fixation of Skeletally Immature Ankle Fractures in Pediatric Populations Using Bio-Integrative Implants,\u201d<\/a> was designed to \u201cexplore the outcomes of transitional ankle fractures after operative stabilization with bio-integrative versus metal alloy fixation devices.\u201d<\/p>\n

\n\u2018Comparable to metal-alloy devices, while offering advantages\u2019<\/b><\/p>\n

\nShared in an e-poster today at IPOS 2023 and with hundreds more orthopedic surgeons from the United States and other countries who treat pediatric patients, typically defined as 2\u201321 years of age, the study\u2019s results \u201csuggest that bio-integrative fixation devices provide radiographic fracture healing rates comparable to metal-alloy devices in treating transitional ankle fractures, while offering advantages in terms of complication rates, re-operation rates, cost-efficiency for patients, and quality of life.\u201d<\/p>\n

\nThey also \u201cdemonstrate bio-integrative fixation devices\u2019 viability as an alternative to metal screws, most significantly, by saving a child from a second surgery,\u201d the poster concludes.<\/p>\n

\nDr. Solomon is scheduled to present on his center\u2019s OSSIOfiber study results at ACFAS 2024<\/a> \u2013\u2013 next year\u2019s annual meeting of the American College of Foot and Ankle Surgeons from Feb. 1\u20134 in Tampa, Fla. \u2013\u2013 on Feb. 2. Meanwhile, he offered his view on their significance:<\/p>\n

\n\u201cMy excitement about our contribution to the growing body of evidence on OSSIOfiber implants stems largely from the fact that this innovation in material science addresses the primary issue with fixing foot and ankle fractures in children \u2013\u2013 namely, that their bones are still developing as they continue to grow into young adults. Because OSSIO\u2019s medical technology naturally integrates with native bone, they don\u2019t need to be removed, saving our pediatric patients from a second surgery.\u201d<\/p>\n

\n\u2018Expanding portfolio of OSSIOfiber implants\u2019<\/b><\/p>\n

\n\u201cWith this highly anticipated clearance, OSSIO enters an important segment of orthopedic surgery,\u201d said OSSIO\u2019s chief executive officer, Brian Verrier, \u201cadding to our expanding portfolio of OSSIOfiber implants for the fixation of bone fractures and soft tissue injuries throughout the body in various clinical scenarios \u2013\u2013 now including the treatment of fractures in children as young as two years old. Our innovation promises to be a gamechanger for clinicians, kids and parents dealing with the challenge of fixing fractured bones.\u201d<\/p>\n

\nThe FDA\u2019s approved instructions for the use of these bio-integrative implants in pediatric patients follows:<\/p>\n