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Med...Prod...OutsourcingPatients....with....coronary....total....obstruction....lesions....were....selected....in....another....two....studies....[22,....26],....and....patients....with....stable....or....unstable....angina....were....included....in....two....studies....[23,....25]Any....disagreements....between....the....reviewers....were....discussed....until....a....consensus....was....reachedBoth...reviewers...compared...findings...and...resolved...differences...through...discussion,...after...which...one...study...for...each...eligible...instance...was...captured...for...further...analysis.Data...extractionOne...reviewer...(JP)...conducted...the...data...abstraction...for...all...included...studies...using...pre-specified...extraction...forms,...and...another...reviewer...(KC)...verified...the...accuracy...of...the...data...extracted...from...all...included...reportsPatients....received....aspirin....(100....mg....o.d.)....and....ticlopidine....(250....mg....b.d.)To....date,....33....catheters....made....by....10....manufacturers....have....been....approved,....including....two....devices....in....2010....and....seven....devices....in....2011....[15].In....2011,....1,942....adverse....event....reports....related....to....the....use....of....PTCA....catheters....were....submitted....to....the....FDA....by....the....manufacturers,....an....increase....from....the....883....reported....in....2008....[15]In....2010,....the....FDA....reclassified....standard....PTCA....catheters....from....class....III....to....class....II....(that....is,....lower....risk)....when....used....for....balloon....dilation....to....treat....narrowed....or....blocked....arteries....in....patients....with....coronary....ischemiaIf....we....find....useful....information,....then....this....approach....could....be....adapted....to....monitor....the....safety....of....other....devices.ObjectiveThe....primary....research....objective....is....to....review....systematically....the....medical....and....grey....literature,....published....between....2007....and....2012,....for....post-marketing....surveillance....studies....on....the....frequency....of....incidents....and....malfunctions....associated....with....the....use....of....PTCA....catheters....in....clinical....practice....among....patients....with....CAD.MethodsLiterature....search....strategyWe....identified....the....published....literature....by....searching....the....following....bibliographic....databases:....MEDLINE....(from....1946)....with....in-process....records....and....daily....updates....via....Ovid,....EMBASE....(from....1980)....via....Ovid,....the....Cochrane....Central....Register....of....Controlled....Trials....(2012,....Issue....1)....via....Ovid....and....PubMedConsequently,....it....is....impossible....to....identify....the....specific....device....used....in....a....patient....if....an....adverse....event....occurs....after....the....fact
2010,..[..(accessed..7..February..2012)18.Grey..MattersFor....example,....the....prevalence....of....coronary....artery....disease....(CAD)....in....2005....was....16....million....people....in....the....US,....and....the....estimated....direct....and....indirect....cost....of....CAD....for....2008....was....USD....156.4....billion....[13]In...most...studies,...the...objectives...were...not...to...monitor...the...long-term...safety...aspects...on...the...use...of...PTCA...catheters...in...clinical...practiceEuroIntervention10.1111/j.1524-4733.2008.004761.x.CrossRefPubMedGoogle....Scholar8.Brown....SL,....Bright....RA,..](http://cdn07.dayviews.com/500/_u3/_u8/_u7/_u7/_u9/_u6/u3877966/94010_1504163648/Post_Marketing_Surveillance_Pdf_Download_http_bit_ly_2wKsO8a_Med_Prod_OutsourcingPatients_with.jpg)
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Post Marketing Surveillance Pdf Download >>> http://bit.ly/2wKsO8a
Med...Prod...OutsourcingPatients....with....coronary....total....obstruction....lesions....were....selected....in....another....two....studies....[22,....26],....and....patients....with....stable....or....unstable....angina....were....included....in....two....studies....[23,....25]Any....disagreements....between....the....reviewers....were....discussed....until....a....consensus....was....reachedBoth...reviewers...compared...findings...and...resolved...differences...through...discussion,...after...which...one...study...for...each...eligible...instance...was...captured...for...further...analysis.Data...extractionOne...reviewer...(JP)...conducted...the...data...abstraction...for...all...included...studies...using...pre-specified...extraction...forms,...and...another...reviewer...(KC)...verified...the...accuracy...of...the...data...extracted...from...all...included...reportsPatients....received....aspirin....(100....mg....o.d.)....and....ticlopidine....(250....mg....b.d.)To....date,....33....catheters....made....by....10....manufacturers....have....been....approved,....including....two....devices....in....2010....and....seven....devices....in....2011....[15].In....2011,....1,942....adverse....event....reports....related....to....the....use....of....PTCA....catheters....were....submitted....to....the....FDA....by....the....manufacturers,....an....increase....from....the....883....reported....in....2008....[15]In....2010,....the....FDA....reclassified....standard....PTCA....catheters....from....class....III....to....class....II....(that....is,....lower....risk)....when....used....for....balloon....dilation....to....treat....narrowed....or....blocked....arteries....in....patients....with....coronary....ischemiaIf....we....find....useful....information,....then....this....approach....could....be....adapted....to....monitor....the....safety....of....other....devices.ObjectiveThe....primary....research....objective....is....to....review....systematically....the....medical....and....grey....literature,....published....between....2007....and....2012,....for....post-marketing....surveillance....studies....on....the....frequency....of....incidents....and....malfunctions....associated....with....the....use....of....PTCA....catheters....in....clinical....practice....among....patients....with....CAD.MethodsLiterature....search....strategyWe....identified....the....published....literature....by....searching....the....following....bibliographic....databases:....MEDLINE....(from....1946)....with....in-process....records....and....daily....updates....via....Ovid,....EMBASE....(from....1980)....via....Ovid,....the....Cochrane....Central....Register....of....Controlled....Trials....(2012,....Issue....1)....via....Ovid....and....PubMedConsequently,....it....is....impossible....to....identify....the....specific....device....used....in....a....patient....if....an....adverse....event....occurs....after....the....fact
2010,..[..(accessed..7..February..2012)18.Grey..MattersFor....example,....the....prevalence....of....coronary....artery....disease....(CAD)....in....2005....was....16....million....people....in....the....US,....and....the....estimated....direct....and....indirect....cost....of....CAD....for....2008....was....USD....156.4....billion....[13]In...most...studies,...the...objectives...were...not...to...monitor...the...long-term...safety...aspects...on...the...use...of...PTCA...catheters...in...clinical...practiceEuroIntervention10.1111/j.1524-4733.2008.004761.x.CrossRefPubMedGoogle....Scholar8.Brown....SL,....Bright....RA,....Tavris....DR:....Medical....device....epidemiology....and....surveillance:....patient....safety....is....the....bottom....line2010,..[..(accessed..31..January..2012)Google..Scholar17.New..FDA..rule..reclassifies..PTCA..cathetersInstead,...most...applications...undergo...a...510(k),...a...pre-market...submission...required...by...the...FDA,...where...manufacturers...claim...that...their...device...is...as...safe...and...effective...as...the...comparator...device...available...on...the...marketTwo...studies...did...not...discuss...the...percentage...or...number...of...patients...who...dropped...out...or...were...lost...to...follow-up...before...the...study...ended...[22,...23],...but...three...out...of...57...patients...were...lost...to...follow-up...in...the...PICCOLETO...study...[25]PMA..is..the..strictest..submission..process..and..the..FDA..requires..that..the..submission..contains..valid..scientific..evidence..to..ensure..the..safety..and..effectiveness..of..the..medical..device..during..its..intended..use..[6]
Future....studies....can....explore....the....strengths....and....limitations....of....PMS....databases....administered....by....regulatory....authoritiesIn...addition,...studies...conducted...to...demonstrate...the...effectiveness...and...safety...of...the...devices...for...market...approval...were...not...included...in...this...systematic...review.Article...selectionTwo...individuals...(JP,...KC)...independently...reviewed...the...titles...and...abstracts...of...search...results...and...selected...articles...for...inclusion...based...on...the...eligibility...criteriaMoreover,...the...authors...did...acknowledge...that...failure...to...randomize...the...patient...populations...may...have...influenced...the...study...findings...[26]References1.Maisel....WH:....Medical....device....regulation:....an....introduction....for....the....practicing....physicianBy....performing....a....systematic....review....of....the....literature....to....identify....safety....problems....associated....with....the....device,....we....may....be....able....to....determine....whether....the....published....medical....literature....is....a....useful....source....of....information....to....estimate....the....safety....of....PTCA....cathetersAll..authors..read..and..approved..the..final..manuscriptConclusions...regarding...differences...in...rates...in...this...study...are...impossible...because...of...a...lack...of...randomization.Procedure...complicationsThere...were...no...procedure...complications...associated...with...balloon...or...balloon-coated...catheters...reported...in...two...studies...[22,...29]Table1...is...a...complete...list...of...study...characteristics.Table...1Study...characteristicsFirst...author,...year...and...country...of...publicationStudy...design,...length...of...study,...source...of...fundingPopulationInterventions...and...comparatorsOutcomes:...adverse...events...and...device...malfunctions...associated...with...balloon...angioplastyAl-Lamee,...2011...[31]Retrospective...case...series56...patients...who...underwent...PCI...and...had...grade...III...coronary...perforationAll...patients...received...aspirin...and...a...loading...dose...of...thienopyridine...prior...to...procedureOne...prospective...study...compared...the...long-term...prognosis...following...the...PTCA...procedure...with...coronary...stenting...and...CABG...[24]10.1161/01.CIR.0000134694.78653.B6.CrossRefPubMedGoogle....Scholar13.Rosamond....W,....Flegal....K,....Furie....K,....Go....A,....Greenlund....K,....Haase....N,....Hailpern....SM,....Ho....M,....Howard....V,....Kissela....B,....Kittner....S,....Lloyd-Jones....D,....McDermott....M,....Meigs....J,....Moy....C,....Nichol....G,....O'Donnell....C,....Roger....V,....Sorlie....P,....Steinberger....J,....Thom....T,....Wilson....M,....Hong....Y,....American....Heart....Association....Statistics....Committee....and....Stroke....Statistics....Subcommittee:....Heart....disease....and....stroke....statistics........2008....update:....a....report....from....the....American....Heart....Association....Statistics....Committee....and....Stroke....Statistics....Subcommittee
EpidemiologyIn..these..studies..[27,..28],..there..were..conflicting..results..regarding..balloon..angioplasty..and..guidewiresEach...tool...addresses...how...well...a...study...meets...the...different...components...of...the...study...design...that...may...impact...the...study...findings...and...conclusions...[20].Data...analysis...and...synthesisA...formal...meta-analysis...was...not...performed...since...the...aim...of...this...systematic...review...is...to...identify...and...present...the...literature...on...adverse...events...and...device...malfunctions...for...PTCA...catheters...reported...in...PMS...studies,...rather...than...to...test...a...hypothesisAlthough...Morrison...et...alDR...developed...and...ran...the...literature...search...and...reviewed...draft...versions...the...manuscriptIn-hospital..adverse..events..reported..were..individual..cases..of..myocardial..infarction..and..hematomaReport....of....a....policy....conference....of....the....European....Society....of....CardiologyIn...addition,...the...inclusion...criteria...were...defined...by...the...published...and...grey...literatureElectronic...supplementary...materialThe...online...version...of...this...article...(doi:10.1186/2046-4053-2-94)...contains...supplementary...material,...which...is...available...to...authorized...usersTwo...reviewers...(JP...and...KC)...selected...the...final...articles...for...inclusion...based...on...an...examination...of...the...full...publications
Another..concern..with..surveillance..systems..is..the..challenge..in..accurately..detecting..the..cause..of..the..adverse..eventsThe..medical..device..industry..has..grown..in..the..past..ten..years10.1016/j.amjcard.2009.07.048.CrossRefPubMedGoogle...Scholar28.Chua...SK,...Lee...SH,...Shyu...KG,...Hung...HF,...Lin...SC,...Cheng...JJ:...Incidence,...management,...and...clinical...outcomes...of...procedure-related...coronary...artery...perforation:...analysis...of...13,888...coronary...angioplasty...proceduresInnovative...study...designs...and...statistical...methods...to...measure...the...safety...and...effectiveness...of...medical...devices...require...further...explorationFurthermore,..the..patient..outcomes..for..1,662..adverse..event..reports..submitted..to..the..FDA..remained..unknownAspirin...and...coumarin...were...administered...following...discharge,...as...necessaryMortality:Approximately...8.5...yearsPTCA...Group:...478...patients...received...heparin...(10,000...IU)...prior...to...the...procedure2002,...13...(Suppl...3):...S10-S14.CrossRefPubMedGoogle...Scholar11.Dhruva...SS,...Bero...LA,...Redberg...RF:...Strength...of...study...evidence...examined...by...the...FDA...in...premarket...approval...of...cardiovascular...devicesPMS...collects...data...from...the...monitoring...and...assessment...of...adverse...reactions...to...marketed...health...products,...as...well...as...standard...market...intervention...and...communication...procedures,...and...associated...policy...development...and...business...transformation...activities...[9]Further....investigations....are....required....to....improve....current....surveillance....systemsThe..FDA..launched..MedSun,..a..Medical..Product..Safety..Network,..in..2002 3c092786bf
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