Knee Hurt

Category: Knee deformation

  • OrthoPediatrics Corp. launches platform for pediatric nailing | Shin

    OrthoPediatrics Corp. launches platform for pediatric nailing | Shin

    WARSAW, Ind., October 19, 2023 (GLOBE NEWSWIRE) — Orthopediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused solely on advancing the field of pediatric orthopedics, today announced that it has released the new Pediatric Nailing Platform TIBIA System and has successfully completed the first cases of the limited launch has completed. The company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in September 2023.

    PNP Tibia is part of the Trauma & Deformity Correction product range and represents another pediatric-focused solution for the treatment of patients with lower extremity fractures and deformities. It expands the company’s offering to 52 unique systems specifically designed to help address the needs of pediatric patients. The PNP tibial system features rigid cannulated nails ranging in diameter from 7 mm to 12 mm and includes specialized instrumentation to facilitate multiple surgical techniques. Like other OrthoPediatrics products, this system is designed for the anatomy of children and growing patients.

    The versatility and scope of the PNP Tibia System were on full display in these two surgical cases. One case was a trauma procedure for a 6-foot teenager requiring a large nail (12mm x 420mm), while the other was a deformity correction procedure for a 15-year-old of smaller stature requiring a 7mm x 285mm was used. These two cases reflect that OP has the broadest scope of pediatric-focused cannulated nails in the industry, allowing surgeons to treat children of all sizes and needs.

    Joe Hauser, president of OrthoPediatrics Trauma & Deformity Correction, said: “It is extremely gratifying to see the system perform successfully in two unique and challenging cases. It shows that the surgeon’s expert design team together with the OP engineers have achieved a goal in designing a system that will help many children for years to come.”

    About OrthoPediatrics Corp.
    Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such, it has developed the most comprehensive product offering for the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 52 systems serving three of the largest categories within the pediatric orthopedic market. This product offering includes trauma and deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization focuses exclusively on pediatric orthopedics and distributes its products in the United States and more than 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.

    Contact person for investors
    Philip Trip Taylor
    Gilmartin Group
    philip@gilmartinir.com
    415-937-5406

    Source link

  • Cerapedics Reinforces Commitment to Level 1 Evidence with Long-Term Results from Six-Year Central IDE Cervix Study Showing 98.6% of Spinal Fusions Occurring in Patients Treated with i-FACTOR®

    Cerapedics Reinforces Commitment to Level 1 Evidence with Long-Term Results from Six-Year Central IDE Cervix Study Showing 98.6% of Spinal Fusions Occurring in Patients Treated with i-FACTOR®

    WESTMINSTER, Colo., Oct. 17, 2023 /PRNewswire/ — Cerapedics Inc., a commercial-stage orthopedic company committed to redefining the standard of care for bone repair, today announced long-term follow-up data from its pivotal IDE study of i-FACTOR Peptide-Enhanced Bone Graft. Published data demonstrated single-level anterior cervical discectomy and fusion (ACDF) fusion rates of 98.6% after six years in patients treated with i-FACTOR and reinforce Cerapedics’ commitment to accumulating long-term clinical evidence. In particular, the results support the safety and efficacy profile of i-FACTOR at one and two years, as published in Spine And Neurosurgery.

    i-FACTOR has demonstrated statistical superiority over local autograft in overall success* at one- and two-year endpoints for single-level ACDF. i-FACTOR further demonstrated spine fusion rates of 89.7%, 97.3% and 98.6% at one, two and six years, respectively, versus 85.8%, 95.8% and 97.3% for local autograft, with results published in Spine And Neurosurgery. 220 of the original 319 patients were observed for six years or 72 months.

    The six-year results, published earlier this year in Neurosurgery, were based on a single-blinded, randomized, controlled prospective study of i-FACTOR compared to local autograft in single-level ACDF, which enrolled a total of 220 patients, including 106 in the i-FACTOR group and 114 in the local autograft control arm. Of the 22 locations from the original IO study, 17 participated in this six-year post-approval study.

    “Physicians are looking for long-term safety and efficacy data to support decision-making about the safest and most effective spine technologies,” said Professor Paul Arnold, CARLE Illinois College of Medicine, principal investigator and author of the 12-, 24- and publications from 72 months. “In this unique long-term follow-up data from a pivotal IDE study, i-FACTOR met all four FDA-mandated non-inferiority success criteria and demonstrated safety and efficacy in single-level anterior cervical discectomy and fusion compared to autograft at 12 years of age age. , 24 and 72 months.”

    “These results clearly demonstrate the efficacy rates and safety profile of i-FACTOR over time and also reflect Cerapedics’ commitment to producing the highest quality evidence on the use of our products,” said Valeska Schroeder, Chief Executive Officer of Cerapedics. “Combined with the results of the IDE study, these data contribute to the clinical understanding of the efficacy and safety of i-FACTOR. While there are numerous other bone grafting options, many have not undergone the same level of testing. This data has a significant impact on insurance payers looking for Level 1 evidence when making coverage decisions.”

    i-FACTOR is available in the US through pre-market approval. It is the most stringent type of marketing application required by the FDA and involves the process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices based on Level 1 clinical trials. Cerapedics is currently conducting its second clinical randomized controlled trial for an indication for transforaminal lumbar interbody fusion (TLIF) involving 290 subjects, which is registered onclinicaltrials.gov.

    About i-FACTOR Peptide-enhanced bone graft
    i-FACTOR is a Class III FDA-approved bone graft supported by rigorous Level 1 human clinical data from an IDE study published in Spine And Neurosurgery. It is the only spinal bone graft powered by P-15 osteogenic cell-binding peptide, with a precise bone-building mechanism.** i-FACTOR has a demonstrated safety profile and is as safe as local autograft in single-level ACDF with proven statistical superiority overall success* after one and two years.

    i-FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for the reconstruction of a degenerated cervical intervertebral disc at one level from C3-C4 to C6-C7. i-FACTOR Peptide Enhanced Bone Graft should be used in an allograft bone ring and with additional anterior plate fixation. For more information, full description of the indication for use, contraindications, safety warnings etc. about i-FACTOR, please visit our website: https://www.cerapedics.com/sites/default/files/2023-08/40002 – 07-4%20Putty%20USA.pdf

    About Cerapedia
    Cerapedics is a global commercial-stage orthopedic company that aims to redefine the standard of care for bone repair by healing bones faster and faster, without compromising safety, so patients can live their healthiest lives. Bone grafts, including Cerapedics products, are used in more than four million spine, orthopedics, trauma and interventional procedures worldwide each year. i-FACTOR is a Class III FDA-approved product indicated for single-level ACDF. Cerapedics’ new “P-15 Bone Graft” product is currently being evaluated for use in lumbar interbody fusion through ASPIRE, a pivotal clinical trial, and has received Breakthrough Device Designation from the FDA. Cerapedics is headquartered in Westminster, CO.

    For more information, please visit us at www.cerapedics.com.

    Media contact:
    Ten Bridge communications
    TBCCerapedics@tenbridgecommunications.com

    *Defined as meeting the Fusion, Function (Neck Disability Index), Neurological, and Safety endpoints
    **Surface-based mode of action

    SOURCE Cerapedics Inc.

    rt

    Source link

  • Superior Polymers releases breakthrough medical-grade PEEK composite, combining carbon fiber, hydroxyapatite and polyether-ether ketone for medical applications

    Superior Polymers releases breakthrough medical-grade PEEK composite, combining carbon fiber, hydroxyapatite and polyether-ether ketone for medical applications

     

    First combination of three clinically proven biomaterials now available for the manufacture of medical devices such as spinal and cardiovascular implants

    FLOWOOD, Miss., Oct. 17, 2023 (GLOBE NEWSWIRE) — Superior Polymers, an innovator in advanced materials for medical applications, today announces the launch of Magnolia Trinity PEEK, which brings together three clinically proven biomaterials. Magnolia Trinity PEEK combines carbon fiber, hydroxyapatite and polyetheretherketone – three crucial materials needed in high-performance medical applications. Now Magnolia Trinity PEEK offers unparalleled versatility, biocompatibility and durability for medical devices such as orthopedic and cardiovascular implants or surgical instruments, catheter components and more.

    “Superior Polymers pushed the boundaries of materials science to create Magnolia Trinity PEEK,” said Bob Fruge, director of Business Development for Superior Polymers. “Bringing these three proven materials together in one application is unprecedented. This new composite material opens up new possibilities for the use of implantable polymers for engineers, designers and manufacturers. We are thrilled to bring Magnolia Trinity PEEK to our customers and the marketplace to ultimately improve patient outcomes.”

    Multiple studies have proven the positive effects of hydroxyapatite, carbon fiber and polyetheretherketone.i Carbon fiber is known for its exceptional mechanical properties, while hydroxyapatite is a natural mineral component of bone, known for its osteoconductive properties. By combining these materials, multifunctional composites can be created that can simultaneously provide structural support, promote bone growth and resist wear and tear.

    Magnolia Trinity PEEK is easily machinable and can be easily customized to specific medical device designs. This versatility allows for the creation of complex and patient-specific implants.

    Additional key features and benefits of Magnolia Trinity PEEK include:

    • Fatigue resistance: Carbon fiber reinforcement improves the fatigue resistance of PEEK.
    • Reduced wear and friction during joint replacement and prosthetics: High abrasion resistance and low friction properties due to the presence of carbon fiber are advantageous in applications involving hinged or sliding components, such as joint replacements and prosthetics.
    • Osteoconductive potential: Hydroxyapatite is a naturally occurring mineral found in bone and when combined with PEEK it improves the osteoconductive properties of the material.
    • Improved radiolucency: Carbon fibers improve radiolucency compared to pure PEEK, which is relatively radiopaque.
    • Better hemocompatibility: Higher crystallinity of the composite can cause less hemolysis and thrombin formation and reduce platelet adhesion, making it a promising material for cardiovascular applications.

    Magnolia Trinity PEEK is available now. Visit superior-polymers.com today to schedule a consultation to learn more and explore its potential applications with a materials expert. Representatives from Superior Polymers will attend the upcoming annual North American Spine Society (NASS) event in Los Angeles, CA, October 18-21, 2023. To schedule a meeting, email Bob Fruge at bob.fruge@superior-polymers.com.

    About superior polymers

    Superior Polymers is a leading innovator in advanced materials, committed to delivering cutting-edge solutions to industries around the world. With a strong focus on customer service, our team of experts strives to create materials that exceed expectations in performance, durability and versatility. More information at www.superior-polymers.com.

    Contact:

    Email address: bob.fruge@superior-polymers.com

    Phone number: 601-345-4515

    Company website: http://www.superior-polymers.com

    Social media links: https://www.linkedin.com/company/superior-polymers/

    PR contact
    Melany Joy Beck | melany.beck@512financial.com
    Cell: (737) 900-7986

    i https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4987717/

    https://pubmed.ncbi.nlm.nih.gov/25780341/

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c3d86fcc-172b-4d59-b90c-e983978048cf

    Source link