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Circulation Journal : Official Journal... Feb 2018Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The... (Review)
Review
Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.
Topics: Drug-Eluting Stents; Equipment Design; Equipment and Supplies; Health Care Sector; Humans; Internationality; Japan; Prostheses and Implants
PubMed: 28883226
DOI: 10.1253/circj.CJ-17-0533 -
Cleveland Clinic Journal of Medicine 1992
Topics: Adolescent; Adult; Autoimmune Diseases; Female; Fibromyalgia; Humans; Mammaplasty; Prostheses and Implants; Prosthesis Failure; Silicones; Silicosis
PubMed: 1468135
DOI: 10.3949/ccjm.59.5.539 -
Clinical Microbiology and Infection :... Aug 2020The use of implanted medical devices is associated with a small but clinically important risk of foreign body infection. A key question is: why do some patients develop... (Review)
Review
BACKGROUND
The use of implanted medical devices is associated with a small but clinically important risk of foreign body infection. A key question is: why do some patients develop chronic infection associated with an implanted device, but most do not?
AIMS
The literature on patient-specific risk factors for chronic infections associated with five types of implants was surveyed to glean clues about the etiology of these infections.
SOURCES
Data were collected from 47 articles through calendar year 2017 for five categories of device-related infections: cardiovascular implantable electronic devices (CIEDs), hernia meshes, prosthetic hip and knee joints, prosthetic shoulder joints and breast implants.
CONTENT
Important risk factors include immunomodulation/steroid therapy, diabetes, smoking, and renal disease/haemodialysis-findings that point to a critical role of a compromised innate immune response in determining vulnerable subpopulations.
IMPLICATIONS
A model of biofilm-related device infection is presented that posits defects in the innate immune response both systemically and locally, in the immediate vicinity of an abiotic biomaterial. The limitations of in vitro and animal models of chronic device-related infections are discussed in this context as are implications for research and clinical practice.
Topics: Animals; Biofilms; Breast Implants; Female; Foreign-Body Reaction; Humans; Joint Prosthesis; Male; Prostheses and Implants; Prosthesis-Related Infections; Risk Factors; Surgical Mesh
PubMed: 32120041
DOI: 10.1016/j.cmi.2020.02.027 -
American Journal of Men's Health 2019Orchiectomy is the standard of care for many testicular conditions. Testicular prosthesis placement (TPP) can mitigate psychosocial burden, restore self-image, and...
Orchiectomy is the standard of care for many testicular conditions. Testicular prosthesis placement (TPP) can mitigate psychosocial burden, restore self-image, and improve quality of life for patients requiring orchiectomy. Limited data exist regarding patient attitudes and counseling on TPP in the United States. The objective of this study was to characterize patient experiences after TPP, rationale for pursuing/declining TPP, and satisfaction levels. Patients with a history of urologic conditions warranting orchiectomy were identified and sent an anonymous survey addressing demographics, pre/post counseling, attitudes toward TPP, satisfaction rates, and postoperative complications. Sixteen percent (76/480) of patients completed the survey. Of these, 50.8% (32/63) undergoing orchiectomy were counseled by their surgeon about TPP, and 22.2% (14/63) received a prosthesis. The most common reasons for declining TPP included lack of concern for cosmetic appearance and lack of counseling. Leading reasons for pursuing TPP included improving self-confidence and cosmetic appearance. Although 71% (10/14) of patients were satisfied with TPP, they did highlight areas for improvement. Twenty percent (2/10) felt their implant was too high, 60% (6/10) felt their implant was too firm, 10% (1/10) endorsed discomfort during sex, and 30% (3/10) felt that TPP did not match their size expectations. Despite these findings, 71% (10/14) reported that they would have TPP again and 79% (11/14) would recommend TPP to others. TPP improves body image and quality of life following orchiectomy. Provider counseling plays an important role in influencing a patient's decision to undergo TPP. Areas of improvement include implant positioning and more effective replication of testicular consistency.
Topics: Adult; Body Image; Follow-Up Studies; Humans; Male; Orchiectomy; Patient Satisfaction; Prostheses and Implants; Prosthesis Implantation; Quality of Life; Testicular Neoplasms; Young Adult
PubMed: 31359823
DOI: 10.1177/1557988319861019 -
British Medical Journal Apr 1969
Topics: Aged; Female; Femoral Neck Fractures; Fracture Fixation; Humans; Leg Injuries; Necrosis; Prostheses and Implants
PubMed: 5780420
DOI: No ID Found -
Aesthetic Surgery Journal Jan 2019Currently, there is a dearth of information regarding the degree of particle shedding from breast implants (BIs) and what are the general biological consequences of BI... (Comparative Study)
Comparative Study Review
Currently, there is a dearth of information regarding the degree of particle shedding from breast implants (BIs) and what are the general biological consequences of BI debris. Thus, it is unclear to what degree BI debris compromises the long-term biological performance of BIs. For orthopedic implants, it is well established that the severity of biological reactivity to implant debris governs long-term clinical performance. Orthopedic implant particulate debris is generally in the range of 0.01 to 100 μm in diameter. Implant debris-induced bioreactivity/inflammation is mostly a peri-implant phenomenon caused by local innate immune cells (eg, macrophages) that produce proinflammatory cytokines such as tumor necrosis factor-α, interleukin-1β, interleukin-6, and prostaglandin 2 (PGE2). In orthopedics, there have been few systemic concerns associated with polymeric implant debris (like silicone) other than documented dissemination to remote organs (eg, liver, spleen, etc.) with no known associated pathogenicity. This is not true of metal implant debris where normal (well-functioning) implants can induce systemic reactions such as delayed type hypersensitivity. Diagnostic analysis of orthopedic tissues has focused on innate (macrophage mediated) and adaptive (lymphocyte-mediated hypersensitivity) immune responses. Orthopedic implant debris-associated lymphocyte cancers have not been reported in over 40 years of orthopedic literature. Adaptive immune responses such as hypersensitivity reactions to orthopedic implant debris have been dominated by certain implant types that produce specific kinds of debris (eg, metal-on-metal total joint prostheses). Orthopedic hypersensitivity responses and atypical BI bioreactivity such as BI-associated anaplastic large cell lymphoma share crossover markers for diagnosis. Differentiating normal innate immune reactivity to particles from anaplastic large cell lymphoma reactions from delayed type hypersensitivity reactions to BI-associated implant debris remains unclear but vital to patients and surgeons.
Topics: Breast Implants; Cytokines; Humans; Immunity, Innate; Inflammation; Lymphoma, Large-Cell, Anaplastic; Orthopedic Procedures; Prostheses and Implants; Prosthesis Design; Prosthesis Failure
PubMed: 30715176
DOI: 10.1093/asj/sjy335 -
The Journal of Thoracic and... Aug 2019
Topics: Magnetic Resonance Imaging; Prostheses and Implants; Prosthesis Implantation
PubMed: 31014662
DOI: 10.1016/j.jtcvs.2019.03.067 -
The Bone & Joint Journal Jan 2017
Topics: Arthroplasty, Replacement; Humans; Prostheses and Implants
PubMed: 28053248
DOI: 10.1302/0301-620X.99B1.38084 -
Journal of Controlled Release :... Oct 2018Bacterial contamination of implantable biomaterials is a significant socioeconomic and healthcare burden. Indeed, bacterial colonization of implants after surgery has a...
Bacterial contamination of implantable biomaterials is a significant socioeconomic and healthcare burden. Indeed, bacterial colonization of implants after surgery has a high rate of incidence whereas concurrent prophylaxis using systemic antibiotics has limited clinical success. In this work, we develop enzyme-prodrug therapy (EPT) to prevent and to treat bacteria at interfaces. Towards the overall goal, novel prodrugs for fluoroquinolone antibiotics were developed on a privileged glucuronide scaffold. Whereas carbamoyl prodrugs were not stable and not suitable for EPT, glucuronides containing self-immolative linker between glucuronic acid masking group and the antibiotic were stable in solution and readily underwent bioconversion in the presence of β-glucuronidase. Surface coatings for model biomaterials were engineered using sequential polymer deposition technique. Resulting coatings afforded fast prodrug conversion and mediated antibacterial measures against planktonic species as evidenced by pronounced zone of bacterial growth inhibition around the biomaterial surface. These biomaterials coupled with the glucuronide prodrugs also effectively combatted bacteria within established biofilms and also successfully prevented bacterial colonization of the surface. To our knowledge, this is the first report of EPT engineered to the surface of biomaterials to mediate antibacterial measures.
Topics: Biofilms; Coated Materials, Biocompatible; Escherichia coli; Escherichia coli Infections; Fluoroquinolones; Glucuronidase; Glucuronides; Humans; Prodrugs; Prostheses and Implants; Prosthesis-Related Infections; Staphylococcal Infections; Staphylococcus epidermidis
PubMed: 30138714
DOI: 10.1016/j.jconrel.2018.08.025 -
JACC. Cardiovascular Imaging Mar 2023
Topics: Humans; Transcatheter Aortic Valve Replacement; Predictive Value of Tests; Aortic Valve; Aortic Valve Stenosis; Prostheses and Implants; Heart Valve Prosthesis; Treatment Outcome; Prosthesis Design; Heart Valve Prosthesis Implantation; Risk Factors
PubMed: 36123288
DOI: 10.1016/j.jcmg.2022.08.010