FDA will require a new Limitations of Use statement in the Indications and Usage section of the labels for these drugs. This notice does not affect bisphosphonate drugs that only are used to treat Paget's disease or high blood calcium levels due to cancer (i.e., Didronel, Zometa, Skelid, and their generic products).Īlthough the optimal duration of bisphosphonate use for osteoporosis is unknown, these atypical fractures may be related to long-term term bisphosphonate use. Zfuse osteoconductive peek fda plus#The bisphosphonates affected by this notice are only those approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast (and their generic products). Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Diaphyseal femur fractures occur in the long part of the thigh bone. Osteoporotic fractures can result in pain, hospitalization, and surgery.Ītypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. This information will be added to the Warnings and Precautions section of the labels of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis.īisphosphonates are a class of medicines that can be effective at preventing or slowing the loss of bone mass (osteoporosis) in postmenopausal women, thus reducing the risk of common osteoporotic bone fracture. Food and Drug Administration (FDA) is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. Zfuse osteoconductive peek fda update#In the last four months, Nvision enhanced its portfolio with four FDA approved products, with one currently being reviewed by the FDA and two others scheduled for submission.This information is an update to the FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures issued on March 10, 2010.Īdditional Information for Healthcare Professionals Its PEEK-OPTIMA HA Enhanced material has a modulus similar to bone and allows artifact-free imaging and provides an osteoconductive surface for bone on-growth, said Nvision.Įstablished in 2013, Nvision is a large-scale medical device manufacturer based in San Antonio, US, with 23 FDA approved devices across different orthopaedic specialities. Trigon Stand-Alone Subtalar Wedge has a 25mm diameter and offers correction heights ranging from 6mm to 16mm in parallel and angled options. In addition, the system comes with a triplanar correction feature, where a jerk allows for frontal plane rotation, along with the ability to restore and maintain the length of the first metatarsal. The wedge is offered in three footprint sizes, with several lengths restoring thicknesses and variations in sagittal and transverse angle correction. The FDA approval indicates Trigon Lapidus Wedge as a PEEK-OPTIMA HA Enhanced implant for a first metatarsal-cuneiform lengthening arthrodesis.Īccording to the company, Trigon Lapidus Wedge is the first implant to specifically reference lengthening in its FDA indication. “By taking an innovative approach to marrying the best materials, manufacturing platforms, and engineering science, we are changing the conversation around foot and ankle surgery.” Nvision product development senior vice president Tom Zink said: “We are always looking at new ways to address different foot and ankle procedures that will benefit the patient and surgeon. The Lapidus and Subtalar Fusion Wedges, part of the expanded Trigon product line, mark the company’s fifth and sixth medical devices to use PEEK-OPTIMA HA Enhanced. PEEK-OPTIMA HA Enhanced is a spinal device technology used for material enhancement.ĭeveloped by Invibio Biomaterial Solutions, the polymer is said to promote multi-directional bone healing and allows for improved fixation. Nvision Biomedical Technologies has received the US Food and Drug Administration (FDA) approval for the first use of PEEK-OPTIMA HA Enhanced with its Lapidus and Subtalar Fusion Wedges. PEEK-OPTIMA HA Enhanced promotes multi-directional bone healing. With the FDA approval, Nvision’s expanded Trigon family of Wedge systems will use PEEK-OPTIMA HA Enhanced along with lengthening capabilities
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