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PubMedDate not supplied

Limited resection based on reclassification of segment 8 of the liver.

Liver vein patterns which differ from those previously described are occasionally encountered during surgery. Therefore, we reclassified the anterosuperior segment (S8) into S8v (ventral area) and S8d (dorsal area), and the right paramedian sector into the ventral segment (S8v+S5) and the dorsal segment (S8d) based on portal and hepatic vein patterns. Using this new classification, we performed three types of limited resection of S8 in six patients with neither major nor minor procedural complications including biliary leaks, and no blood transfusion. This new classification allows development of surgical procedures where resection is limited to the portal unit and tumor.

Carcinoma, Hepatocellular↗
PubMed2004

Dental devices; reclassification of root-form endosseous dental implants and endosseous dental implant abutments. Final rule.

The Food and Drug Administration (FDA) is reclassifying root-form endosseous dental implants and endosseous dental implant abutments from class III to class II (special controls). Root-form endosseous dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are separate components that are attached to the dental implant and intended to aid in prosthetic rehabilitation. FDA is reclassifying these devices on its own initiative on the basis of new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for these devices. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002.

Dental Implants↗
PubMedDate not supplied

Structure of the O-polysaccharide of Proteus mirabilis O19 and reclassification of certain Proteus strains that were formerly classified in serogroup O19.

INTRODUCTION: Bacteria of the genus Proteus are a common cause of urinary tract infections. The O-polysaccharide chain of their LPS (O-antigen) defines the serological specificity of these bacteria. Based on the immunospecificity of the O-antigens, two species, P. mirabilis and P. vulgaris, were classified into 49 O-serogroups, and more O-serogroups for strains of these species and P. penneri have been subsequently proposed. MATERIAL AND METHODS: The lipopolysaccharide of P.mirabilis CCUG 19011 from serogroup O19 was degraded under mildly acidic and mildly alkaline conditions. Polysaccharides thus obtained were studied by chemical methods, including O -deacetylation, sugar and methylation analyses, and 1H- and 13C-NMR spectroscopy. Antisera were obtained by immunization of New Zealand white rabbits with heat-killed bacteria. In serological studies, enzyme immunosorbent assay, passive hemolysis test, and inhibition of passive hemolysis were used. RESULTS: The following structure of the O-polysaccharide repeating unit was established:-->3)- beta-D-GlcrhoNAc-(1-->3)- alpha-D-GalrhoNAc4,6(R-Pyr)-(1-->4)- a-D-GalrhoA-(1-->3) alpha-L-Rhap2Ac-(1-->where R-Pyr is (R)-1-carboxyethylidene (an acetal-linked pyruvic acid). This structure is significantly different from the O-polysaccharide structures of P. vulgaris, P.hauseri and P. penneri strains from the same Proteus serogroup O19. CONCLUSIONS: Based on immunochemical studies of the lipopolysaccharides, it is suggested 1) to keep P. vulgaris CCUG 4654 and P. penneri 31 in serogroup O19 as two subgroups, 2) to reclassify P. mirabilis CCUG 19011 into a new Proteus serogroup, O51, and 3) to classify serologically related strains, including P. vulgaris ATCC 49990, P. hauseri> 1732-80 and 1086-80, P. penneri 15, and some other P. penneri strains, in yet another Proteus serogroup, O52.

Animals↗
PubMed2004

Cardiovascular and neurological devices; reclassification of two embolization devices. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to reclassify two embolization device types from class III (premarket approval) into class II (special controls). The agency is also changing the names and revising the identifications of these devices. The vascular embolization device (previously the arterial embolization device) is intended to control hemorrhaging due to aneurysms, certain types of tumors, and arteriovenous malformations. The neurovascular embolization device (previously the artificial embolization device) is intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. FDA is reclassifying these devices on its own initiative on the basis of new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for these devices.

Cardiology↗
PubMed2005

Dental devices; reclassification of tricalcium phosphate granules and classification of other bone grafting material for dental bone repair. Final rule.

The Food and Drug Administration (FDA) is reclassifying tricalcium phosphate (TCP) granules for dental bone repair from class III to class II (special controls), classifying into class II (special controls) other bone grafting material for dental indications, and revising the classification name and identification of the device type. Bone grafting materials that contain a drug that is a therapeutic biologic will remain in class III and continue to require a premarket approval application. The classification identification includes materials such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II devices.

Bone Substitutes↗
PubMedDate not supplied

[Identification and reclassification of methylotrophic bacteria].

Species status of the already described methylotrophic bacteria has been specified, and new isolates have been identified. The bacteria under study are classified as those from Methylobacterium genus on the basis of a set of diagnostic characteristics (they are capable to assimilate, besides methanol, other organic substances; to realize serine cycle of one-carbon compounds assimilation, to form rast-coloured colonies; they can form rosy-coloured colonies). As a result of the study of phenotypical characteristics in 14 strains of Methylobacterium and sequence-analysis of the gene 16S pRNA two strains: T-2 (=UKM B-3357) and strain ch-8 (=UKM B-3352) are identified as M. mesophilicum, strain A-5 (=UKM B-3381)--as M. extorquens; several strains were reclassified. The strain 9-17 (=UKM B-3339) is related to the species M. zatmanii (described before as M. organophilum), strain 13-17 (=UKM B-3342)--to the species M. fujisawaense (formerly--M. organophilum), K-2 (=UKM B-3351)--to the species M. fujisawaense (formerly--M. extorquens). Phenotypical characteristics differentiating the studied species of Methylobacterium are suggested. Identification of the strains of Methylobacterium genus based on sequence analysis of genes 16S pRNA is in agreement with the results obtained when studying phenotypical properties.

Bacterial Typing Techniques↗
PubMedDate not supplied

[Reclassification of thermophylic methane-oxidizing bacteria with the use of sequence-analysis of 16S rRNA genes].

The authors have performed sequence-analysis of 16S rRNA genes of thermophylic methane-oxidizing bacteria UCM B-3026, UCM B-3032, UCM B-3109, UCM B-3014 which were isolated from sludge pond of different regions in Ukraine and deposited at Ukrainian Collection of Microorganisms (UCM) as Methylococcus thermophilus and "M. gracilis". A comparative analysis of 16S rRNA gene sequences of the studied bacteria with those sequences of various strains of bacteria in the GenBank databases has shown that the level of similarity of the strains UCM B-3026, UCM B-3032, UCM B-3109 with Methylocaldum szegediense was 98.0-98.7%, strain UCM B-3014 with Methylocaldum gracile--99.1%, that allows to relate them to these species. As to other species of the genus Methylocaldum, these strains had a lower level of similarity (94.8-97.2 %) and with Methylococcus thermophilus ACM 3585T (= IMV-B-3037T = UCM B-3037T)--less than 90%. Thus, the strains UCM B-3026, UCM B-3032, UCM-3109 were reclassified as Methylocaldum szegediense, strain UCM B-3014--as Methylocaldum gracile. When constructing phylogenetic tree based on the comparison of 16S rRNA genes with the use of various algorithms realized in the packages of programs Tree View (version 1.5.2) and ClastalX (version 1.81) certain clusters have formed genera Methylocaldum, Methylococcus and Methylomonas. Genera Methylobacter and Methylomicrobium have formed three clusters, one of the clusters contained two species of Methylobacter and two species of Methylomicrobium. Apparently, the taxonomy of genera Methylobacter and Methylomicrobium is to be specified.

Genes, Bacterial↗
PubMed1990

Plasmodium falciparum--chloroquine in vivo test in northeast India: reclassification and extended follow-up till day 14.

In vivo test for the susceptibility of Plasmodium falciparum to chloroquine was carried out in 390 patients. Parasite density was analysed by calculating the mean of each day's parasite count and the value was expressed per microliters of blood. Majority of sensitive and resistant infections attained minimal values on day 4. Further more, this value provides a clear-cut, statistically significant difference between sensitive and RI cases (Z = 2.14, P less than 0.05) RII, RIII cases (Z = 3.86, P less than 0.001). It is proposed that assessment of sensitivity should be based on D-4 parasite density per microliters of blood considering D-0 as base i.e., (proportionate reduction of parasite density on D-4 as compared to that on D-0) utilising the present criterion. In endemic areas, where reinfection is possible, patency on D-14 will nearly always be due to resistance. It is therefore, suggested that a better, more economical and an epidemiologically viable result can be obtained by extension of in vivo test upto D-14.

Animals↗