Expert review of medical devices
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Expert Rev Med Devices · Oct 2017
ReviewManagement of failing bioprosthesis in elderly patients who have undergone transcatheter aortic valve replacement.
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of symptomatic aortic stenosis. The number of TAVR procedures is expected to increase exponentially in the next decade. Therefore, patients will inevitably present with signs and symptoms attributable to TAVR bioprosthesis failure many years after an acutely successful procedure. ⋯ Expert commentary: A key question for TAVR moving forward is its efficacy with regards to long-term durability. The 5-year durability of TAVR prosthesis is excellent but comprehensive longer-term follow-up is awaited. Other mechanisms of failure include: TAVR endocarditis, diagnosis can be challenging and it is essential to have high clinical suspicion; TAVR migration, a rare complication that can be treated with second TAVR prosthesis; TAVR thrombosis, either subclinical identified on computed tomography or obstructive symptomatic thrombosis identified on echocardiogram, both types are effectively treated by formal anticoagulation; TAVR compression, a phenomenon observed in post-mortem examination following cardiopulmonary resuscitation, treatment options include balloon post-dilatation and second TAVR prosthesis implantation.
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Expert Rev Med Devices · Oct 2017
ReviewRetrograde magnetic internal lengthening nail for acute femoral deformity correction and limb lengthening.
The Precice magnetic internal lengthening intramedullary nail is being used with great success in femur lengthening and deformity correction with a retrograde approach. Areas Covered: Our personal history of limb lengthening and the Precice nail will be reviewed. Several technical aspects are discussed including design updates, pre operative planning, selection of nail length, the use of blocking screws and intra operative temporary external fixation, osteotomy practice, post operative management, and cost analysis. ⋯ The few failures that have occurred appear to be attributable to excessive loading of the femur and implant during a vulnerable time of bone healing. Further studies with more uniform outcome criteria need to be conducted to better standardize user's experiences. The higher one time cost of the implant is offset by the reduced number of surgeries needed when compared with the gold standard of lengthening-over-nail-technique, and we suspect that patients return to work sooner due to the ability to wear normal clothing and the reduction in pain throughout the entire lengthening process.
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Expert Rev Med Devices · Sep 2017
ReviewThe use of flexible intramedullary nails in limb lengthening.
Lower and upper limb length discrepancy and deformity, congenital or acquired, are amongst the most common conditions in children for orthopaedic referral. Over the last twenty years, surgical techniques have evolved in an attempt to decrease Healing Index and minimise these complications. Areas covered: The flexible intramedullary nailing (FIN) is a minimally invasive intramedullary osteosynthesis. ⋯ Hydroxyapatite-coated FIN should be applied for long-term reinforcement of lengthened bone in patients with metabolic bone disorders, skeletal dysplasias with compromised bone formation. Osteoinductive surface of nails is favorable for bone formation and as well as for stable position of nails without risks of migration in long-term follow-up. The FIN is an unique intramedullary fixation which respects the bone biology which is mandatory for a good bone consolidation.
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Expert Rev Med Devices · Sep 2017
Review3D printed drug delivery devices: perspectives and technical challenges.
The technological advancements in the pharmaceutical field are constantly improving and provide various possibilities for meeting the needs of personalized drug therapy. The three-dimensional (3D) printing technology has endless potential in the fabrication of patient-specific drug delivery devices (DDD) and dosage forms as the technological development is progressing. Moreover, the rapidly evolving research on 3D printed DDD has enabled us to determine several challenges related to the manufacturing and marketing of personalized drug delivery systems. ⋯ Expert commentary: The 3D printing has enabled the fabrication of prototypes of DDD with varying complexity and shows that customization of drug products is possible. There is potential to improve patient-specific drug therapies of the future using printing technologies. The technological advancements, new scientific concepts, interdisciplinary work and defined regulatory guidelines will continue to support and strengthen the prospects of 3D printing as an option in the manufacture of medical products.
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Expert Rev Med Devices · Aug 2017
Multicenter StudyUtilization of multiple spinal cord stimulation (SCS) waveforms in chronic pain patients.
Advances in spinal cord stimulation (SCS) have improved patient outcomes, leading to its increased utilization for chronic pain. Chronic pain is dynamic showing exacerbations, variable severity, and evolving pain patterns. Given this complexity, SCS systems that provide a broad range of stimulation waveforms may be valuable. ⋯ When given a choice, SCS patients often utilize a variety of waveforms, suggesting that patients may benefit from a single system that provides multiple waveforms and field shapes to customize therapy and improve efficacy.