OPENING THE DOOR TO EASY PORT-SITE CLOSURES....Consistent Closure1 The ™VersaOne fascial closure...
Transcript of OPENING THE DOOR TO EASY PORT-SITE CLOSURES....Consistent Closure1 The ™VersaOne fascial closure...
OPENING THE DOOR TO EASY PORT-SITE CLOSURES.1
Product information guide
VersaOne™ Fascial Closure System
TABLE OF CONTENTS
03 Fulfillinganeedinlaparoscopicsurgery
04 IntroducingtheVersaOne™ fascialclosuresystem
05 Featuresandbenefits
06 Applicationguide
09 Ordering information
SUPPORTING SURGEONS WHEN IT’S CLOSING TIME.
We’reexcitedtointroducethelatestadvancementinourVersaOne™ trocar platformfamily:the VersaOne™ fascial closure system.
LikeallofourVersaOne™trocars,itprovidesaccesstostandardlaparoscopicinstruments.Butitalsodeliversconsistentclosure1oftheportsite.
Thisuniquedeviceispartofourcommitmenttohelpingyouimproveproceduralefficiency—fromtheinitialmomentsofsurgerytothefinalsuture.1,†
†Comparedtothecompetitiveclosuredevice,suturepasser,andsutureonly.
Addressing a Procedural Need
TRADITIONAL SUTURING
Difficultandimprecise,especiallyinobese patientsandinalllaterallyplacedtrocarsite2
SUTURE PASSER
Inexactsutureplacement3
CLOSURE DEVICE
Reinsertionaftertrocar removal
ACCESS AND CLOSURE MADE EASY1
TheVersaOne™fascialclosuresystemisamultifunctionaltoolthatservesasatrocarandafascialclosuredevice.Itdelivers:
▪Consistentport-siteclosure1
▪Addedproceduralefficiency1,† ▪Easeofuse1
WedevelopedtheVersaOne™fascialclosuresystembecausethere’saneedforaconsistentsolutionforclosuresattheportsite.1
Traditionalfascialclosuretechniques:
†Comparedtothecompetitiveclosuredevice,suturepasser,andsutureonly.
Consistent Closure1 TheVersaOne™fascialclosuresystemisdesignedtofacilitateclosureofthefasciaat5mmoneithersideofthewound.4–7
Efficient Access and Closure1
Theall-in-one1systemcanhelpsavetimebecauseit:
▪ Eliminatestheneedtoremovetrocarbeforeclosure1
▪ Makesreinsufflationunnecessary—pneumoperitoneum canbemaintainedthroughouttheprocedure1
▪ MayhelptoreducethenumberofSKUsrequired
FEATURES AND BENEFITS
Visualindicatorsaidintrocarplacement1
Cannulawindowandguidehelpfacilitateclosureofthefasciaat5mmoneithersideofthe cannula defect4–7
A B
Reusable Suture Passer
Needle tip
Flush port
Stop function
ABC
System Components
A
B
C
E
D
F
Guide
Distal black band
Distal cannula window
Proximal black band
Arrow
Obturator
ABCDEF
ALL-IN-ONE ACCESS AND CLOSURE1
How to use the VersaOne™ fascial closure system
C
STEP 1Removethesealhousingonthecannula byrotatingtheself-adjustingseal counter-clockwisewhiledepressing thespecimenremovalbutton.
Important: Do not insert the guide into the seal housing.
STEP 2Fullyinsertthedisposableguideintothe cannulauntilaclickisheardandtheguide islockedinplace.
STEP 3Ensurethedistalblackbandontheguide isalignedwiththeperitoneumandthe proximalblackbandisbelowtheskin.
Specimen removal button
Seal housing
Proximal black band
Distal black band
STEP 4Graspashorttailofsuturewiththe suturepasser.†
STEP 5A.Insertthesuturepasserdown eitheroneofthetwoguidechannels.Advancethesuturepasser andsuturethroughthetissue andintotheabdominalcavity.
B.Usethesecondarygrasperfromthealternateporttograsp thesuture.Releasethesuturefromthesuturepasserjaw.
STEP 6A. Inserttheempty suturepasserdownthe oppositeguidechannelintotheabdominalcavitytograbthesuture.
B.Pickupthesutureandremoveitthroughtheguide.
C.Removethecannulaandguideassemblyfromdefect andtieoff.
†ThetrocarandguidewillaccommodateKarlStorz™*BERCIfascialclosureinstrument.8,9
ORDERING INFORMATION
Code Description Per Box
ONB12STFCS VersaOne™FascialClosureSystemOpticalTrocar 6unitsperbox
B12STFCS VersaOne™FascialClosureSystemBladedTrocar 6unitsperbox
FCSPASS VersaOne™FascialClosureSystemReusableSuturePasser 1unitperbox
1. Basedoninternalvalidationreport#RE00098009RevA,DoubleTimeVersaOne™ fascialclosuresystemMiamilabVOCreport:13outof16surgeonssurveyedagreed.March28,2017.
2. NadlerRB,McDougallE,BullockAD,LudwigMA,BruntLM.Fascialclosureoflaparoscopicportsites:anewtechnique.Urology.1995;45(6):1046–1048.
3. EidGM,CollinsJ.Applicationofatrocarwoundclosuresystemdesignedforlaparoscopicproceduresinmorbidlyobesepatients.Obes Surg.2005;15(6): 871–873.
4. Basedoninternalreport#RE00003570,VOCsummarydetailingcustomerrequirementsforprojectDoubleTime,ascompiledfromsurveysatSAGES2013:16outof16surgeonsagreed.Nov.5,2014.
5. Basedoninternalreport#RE00079705,Fascialclosuresystembitesizeverification.Nov.5,2014.
6. IsraelssonLA.Abdominalincisionclosure:smallbutimportantbites.Lancet. 2015;386(10000):1216–1218.
7. Basedoninternalreport,VOCsummaryreport,CustomerrequirementsforprojectDoubleTimefromsurveysatSAGES2013:16outof16surgeonssurveyedagreed.May6,2013.
8. Basedoninternalvalidationreport#RE00031915,ProjectDoubleTimeVersaOne™ fascialclosuresystem,surgeonformativeusabilityevaluation.November12,2015.
9. Basedoninternalvalidationreport#2197RevC1,ProjectDoubleTimeVersaOne™ fascialclosuresystem,designinputtraceabilitymatrix.March21,2017.
©2020Medtronic.Allrightsreserved.Medtronic,MedtroniclogoandFurther,TogetheraretrademarksofMedtronic.™*Thirdpartybrandsaretrademarksoftheirrespectiveowners.AllotherbrandsaretrademarksofaMedtroniccompany.02/2020–US170389(5)–[WF#1561527]
Important:Alwaysrefertotheinstructionsforuse(IFU)suppliedwiththeproductforcompleteinstructions,indications,contraindications,warnings,andprecautions.
For more information or to order the VersaOne™ fascial closure device, call 800-772-8772Visit us at medtronic.com/versaone-closure