JOSTEN Coronary Stent Graft Sterile,sterilized with ethylene oxide, for single use only! Donot resterilizel INSTRUCTIONS FOR USE Caution: Federal Law restricts this device to sale by or on the order of a physician.

Humanitarian Device. Authorized by Federal Law for the use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ý! 2.75 mm in diameter. The effectiveness of this device for this use has not been demonstrated.

TABLEOF CONTENTS 1.0 DEVICE DESCRIPTION ...... 2 Figure1 JOSTENr CoronaryStent Graft ...... 2 Table1 DeviceSpecifications ...... 2 2.0 INDICATIONS...... 2

3.0 CONTRAINDICATIONS ...... 2

4.0 WARNING ...... 3

5.0 PRECAUTIONS ...... 3 5.1 STENTHANDLING - PRECAUTIONS...... 3 5.2 STENT PLACEMENT- PRECAUTIONS...... 3 5.3 STENT/SYSTEmREMOVAL - PRECAUTIONS...... 4 5.4 POST-STENTPLACEMENT - PRECAUTIONS...... 4 6.0 ADVERSE EVENTS ...... 5 6.1 OBSERVEDADVERSE EVENTS ...... 5 Table2 ProceduralAdverse Events ...... 5 Table3 in-hospitalAdverse Events ...... 5 6.2 POTENTIALADVERSE EVENTS ...... 6 7.0 CLINICAL STUDY ...... 6 7.1 OBJECTIVE...... 6 7.2 DESIGN...... _-_ ...... 6 7.3 RESULTS...... 7 Table4 SummaryTable ...... 7 Table5 PatientDemographics ...... 7 Table6 ProceduralInformation ...... 7 Table7 In-HospitalMACE ...... 7 Table8 ProceduralComplications ...... 8 Table9 ComplicationsatFollow-up ...... 8 7.4 CONCLUSIONS...... 8 8.0 INDIVIDUALIZATIONOF TREATMENT ...... 8 8.1 USE INSPECIAL POPULATIONS ...... 8 9.0 HOW SUPPLIED ...... 9

10.0 OPERATOR'S MANUAL ...... ...... 9 10.1 INSPECTIONPRIOR TO USE ...... 9 10.2 MATERIALSREQUIRED ...... 9 10.3 STENTMOUNTING ...... 9 10.4 DELIVERYPROCEDURE ...... 10 10.5 DEPLOYMENTPROCEDURE ...... 10 10.6 REMOVAL PROCEDURE...... 11 10.7 INVITRO INFORMATION ...... 12 Table10 ExpandedStent Diameter (mm) andLength (mm) Chart, ...... 12

Final9 Jan 01 1 DJ Theseinstructions for useare intended for all personnelwho handle the JOSTENT*Coronary Stent Graft and shouldbe read and understood.Lý usingthe product. The clinical techniques and procedures described hereindo not represent all medicallyaccepted coronary stent Implantation procedures, nor are they intended as a substitutefor the physician's experience, but are offered to clinicians as a guide. 1.0 DEVICE DESCRIPTION JOSTENT9 The Coronary Stent Graft System includes: Two high-grade surgicalsteel flexible stents, manufacturedfrom a solid tube using precision laser technology,with an expandable PTFE graft material wrapped between the two stents. The inner diameter of the stent is 1.8 mm, and the outer diameteris 2.4 mm. " A stent holder used to assist in accurately placingthe stent on a marketed high-pressure, non-compliantPTCA Catheter before hand crimping. JOSTENT* " The CoronaryStent Graft is designedto be physician-mountedon a currently marketed high-pressure,non-compliant PTCA Catheter. The rated burst pressureof the catheter must be at least 14 atm, and the balloonshould displayless than 10% growth from nominaldiameter inflationpressure to rated burst pressure. JOSTEN7' The Coronary Stent Graft has been testedwith several non-compliant balloons,including: the Cordis Titan (RBP=l 6atm), the Scimed NC Ranger (RBP=l 8atm in a stent), and the Scimed Maxxum (RBP=20atm). JOSTENTO Figure 1 Coronary Stent Graft E < E <

TableI 1 Device Specifi ations StentLength VesselDiameters Min.BMloon Min.Balloon RBP Min.Ddoloynieni Min.Guiding length Pressure CatheterID 9mm 2.75- 5.0mm 11mm 14atm 14atm 6 F forstent graftsexpanded 12mm 2.75- 5.0mm 14mm 14atm 14atm to:53.5mm 16mm 2.75- 5.0mm 18mm 14atm 14atm 7 F forstent 19mm 2.75- 5.0mm 21M 14atm 14atm graftsexpanded to>3.5 mm 26mm 2.75- 5.0mm 28" M 14atm 14atm 2.0 INDICATIONS JOSTEN7'0 The CoronaryStent Graft is indicatedfor use in the treatmentof free perforations,defined as free contrastextravasation into the pericardium,in native coronaryvessels or saphenousvein bypass grafts > 2.75mm indiameter. The effectivenessof this device for this use has not been demonstrated.Long-term outcomefor this permanent implant is unknown atpresent.

3.0 CONTRAINDICATIONS JOSTENT' The CoronaryStent Graft is contraindicated foruse in: a Patientsin whom antiplateletand/or anticoagulation therapy is contraindicated.

Patientswho arejudged to have a lesionthat prevents complete inflation ofan angioplastyballoon.

Final9 Jan 01 2 1DIP 4.0 WARNING Patients allergic to surgical stainless steel or PTFE may suffer an allergic reaction to this implant.

5.0 PRECAUTIONS (See also Individualization of Treatment) " Only physicians who have received appropriate angioplasty training should perform implantation of the stent. " Stent placement should only be performed at hospitals where emergency coronary artery bypass surgery can be readily performed. " Subsequent restenosis may require re-dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of coronary stents is unknown. " When multiple stents are required, stent materials should be of similar composition.

5.1 Stent Handling- Precautions " For single use only. Do not resterilizeor reuse. Note product"Use Before"date. " The JOSTENr CoronaryStent Graft is designedto be physician-mountedon a currently marketed high-pressure,non-compliant PTCA Catheter. The rated burst pressureof the catheter must be at least 14 atm, and the balloonshould displayless than 10% growth from nominaldiameter inflationpressure to rated burstpressure. Any coating,onthe delivery PTCA catheter must be removed prior to mountingthe stent. The coatinq onthe PTCA catheter is removed by gentlywiping the PTCA catheter with a compresssoaked in an alcoholsolution (e.ci 70% Ethanol).Do not manipulateor shortenthe stent. Manipulationmay cause the stentsto separate from the PTFE layer (de-laminate). The stent should be placed accuratelybetween the marker bands on the balloonand then hand-crimpedinto place and proximally, the balloon 900 startingdistally working rotating by untilthe stent is securelyfixed. Excessivemanipulation may cause dislodgment of the stent from the deliveryballoon. " Special care must be taken not to handle or in any way disruptthe stent positionon the delivery deviceafter mounting.This is most importantduring placement over the guide wire and advancementthrough the hemostasisvalve adaptorand guidingcatheter hub. " Use onlyappropriate balloon inflationmedia. Do not use air or any gas mediumto inflate the balloonas it may cause unevenexpansion and difficultyin deploymentof the stent.

5.2 Stent Placement -Precautions

Prepare and pre-inflatethe balloonprior to stent mounting,according to the manufacturersInstructions for Use. Purgethe balloonas directedfor mountingof the stent.

Implantinga stent may lead to dissectionof the vessel distaland/or proximalto the stent and may cause acute closureof the vessel requiringadditional intervention (e.g., CABG, furtherdilatation, placement of additionalstents, or other). Please refer to Table 1 for recommendedballoon lengths. The chosen diameterof the balloonshould correspondto the vessel diameter (ratio 1:1). If more then one stent is required,the distalstent shouldbe placed initially,followed by placementof the proximalstent. Stenting in this order obviatesthe need to cross the proximalstent when placingthe distal stent and reducesthe chancesfor dislodgingthe proximalstent.

Final9 Jan01 3 1;L3 Do not expand the stent if it is not properly positioned in the vessel (See Stent/System Removal - Precautions) 0 Placement of the stent will compromise side branch patency.

Balloon pressures should be monitored during inflation. Do not exceed rated burst pressure as indicated on product label. Use of pressures higher than specified on the product label may possibly result in a ruptured balloon and potential intimal damage and dissection. Do not attempt to pull an unexpanded stent back through the guiding catheter; dislodgment of the stent from the balloon may occur. (See Stent/System Removal -Precautions) Stent retrieval methods (use of additional wires, snares, and/or forceps) may result in additional trauma to the vascular access site. Complications may include bleeding, hematoma, or pseucloaneurysm.

5.3 StentlSystem Removal - Precautions Should unusual resistancebe felt at any time, either duringlesion access or duringremoval of the Stent Delivery System post-stentimplantation, the Stent Delivery System and guidingcatheter should be removed as a single unit. This must be done under directvisualization of fluoroscopy. When removing the Delivery System as a single unit. It's recommendedmaintaining guidewire placement across the lesion and carefullypulling back the Stent Delivery System untilthe proximalballoon marker of the Stent Delivery System is alignedwith the distaltip of the guidingcatheter. Do not pull the Stent Delivery System into the guiding catheter. The guidingcatheter and StentDelivery system shouldbe carefullyremoved from the coronaryartery as a single unit. The system shouldbe pulled back into the descendingaorta toward the arterialsheath. As the distalend of the guidingcatheter enters intothe arterialsheath, the catheter will straightenallowing safe withdrawalof the Stent Delivery System intothe guidingcatheter and the subsequentremoval of the Stent Delivery Systemfrom the arterialsheath. Failureto followthese steps and / or applyingexcessive force to the Stent Delivery System can potentiallyresult in loss or damage to the stent or Stent Delivery System components such as the balloon. If it is necessaryto retainguide wire positionfor subsequentartery / lesion access, leave the guide wire in place and remove all the other components.

5.4 Post-Stent Placement - Precautions Care must be exercisedwhen crossinga newlydeployed stent with an intravascular ultrasound(IVUS), or a coronaryguidewire, or ballooncatheter, to avoiddisrupting the stent geometry. Do not performMagnetic Resonance Imaging(MR]) scan on patients post-stentimplantation untilthe stent has been completelyendothelialized (eight weeks)to minimizethe potentialfor migration. The stent may cause artifactsin MRI scans due to distortionof the magneticfield.

Final9 Jan 01 4 '2ý4 6.0 ADVERSE EVENTS Data were collectedfrom a total of 41 patients in a multi-center,retrospective analysis of use of JOSTENT* the CoronaryStent Graft to treat perforations. These patientsform the basis of the observedevents reported (See ClinicalStudies).

6.1 Observed Adverse Events JOSTENT9 A total of 14 of 41 patients (34.1 %) receiving the Coronary Stent Graft experienced one or more adverse events during the procedure. Only one patient (1/41, 2.4%) experienced events post-JOSTENr implantation, due to an incompletely sealed perforation. All other adverse events can be attributed to the perforation since they occurred prior to stent implantation. JOSTENT9 No patients who received the Coronary Stent Graft died, experienced a Q-wave M1, or necessitated emergent CABG during the procedure or in-hospital stay. All stents were successfully delivered. Table 2 Procedural Adverse Events

N occurr6rices Any Adverse Event 14(35.0% ProceduralComplications' Pericardialeffusion 9(22.5%) Tamponade 5(12.5%) Pericardiocentesis 6(15.09/6) Cardiac arrest 1 (2.5%) Hypotension 5(12.5%) Cardiogenicshock 4(10.0%) Bradycardia 4(10.0%) All complicationsoccurred in the cardiaccatheterization laboratory prior to JOSTEW implantation, except for a singleout of lab effusionthat progressedto tamponadeand requiredemergent re-PTCA with placement of a secondJOSTEW, which sealed the perforation. Table 3 In-hospital Adverse Events . . IN oddunrences His toHcal Wtal in-hospitalMACE Free Perforations All Perforations Death 0 20% 9% Emergent CABG 0 60% 37% Q-wave MI 0 10% l 6% I AjluniSC, Glazier S, BlankenshipL, O'Neill WW, Safian RD. Perforationsafter percutaneouscoronary interventions:clinical, anglographic, and therapeuticobservations. Cathet CardiovascDiagn. 1994;32:206-12.

Final 9 Jan 01 5 5- 6.2 Potential Adverse Events Adverse events (in alphabeticalorder) that may be associatedwith the use of a coronarystent in nativecoronary arteriesmay include: " Acute myocardialinfarction " Arrhythmia's(including VF and VT) " Coronaryartery bypasssurgery " Death " Dissection " Drug reactionsto antiplateletagents/contrast medium " Emboli,distal (air, tissue or thromboticemboli) " EmergentCoronary Artery bypassSurgery " Hemorrhage, requiringtransfusion " Hypotension/ Hypertension " Infectionand pain at insertionsite. " Ischemia,myocardial " Perforation " Pseudoaneurysm,femoral " Restenosisof stentedsegment " Spasm " Stent embolization " Stent thrombosis/occlusion " Stroke/CerebrovascularAccidents " Total occlusionof coronaryartery 7.0 CLINICAL STUDY

7.1 Objective JOSTEN70 The objectiveof this study was to evaluate the technicalsuccess and safety of the Coronary Stent Graft as a life-savingtreatment in cases of coronaryartery perforation.

7.2 Design This studywas multicenter,retrospective, and non-randomized. Demographic,clinical, and angiographicdata were collectedon the target population,including in-hospital and limited data. follow-up JOSTEN7" JOMED is aware of a total of 46 perforationstreated worldwidewith the Coronary Stent Graft. Full proceduralcase report forms have been receivedfor 41 of the 46 subjects. Follow-upforms were receivedfor 27 of the 41 evaluablesubjects. The follow-uptime ranged from one week to one year. All subjectswere enrolled after undergoingurgent or emergent use JOSTENTO of the CoronaryStent Graft to treat a native coronaryartery or saphenousvein graft perforation.

Final9 Jan 01 6 7.3 Results J Demographicswere collected for the 41 subjects.Sixty-five percent of the subjectswere male. The subjectshad a highincidence of previousMI (59.0%),previous CABG (27.5%), previous PTCA(30.8%), and CCS ClassIII/IV angina (83.3%). Forthis population, the in-hospitalmajor adversecardiac event ratewas 0%. Therewere no in-hospitalincidents of death, (MACE) JOSTENTO Ml, or emergentCABG. In all cases,the CoronaryStent- Graft was deployedQ-wave successfully.No devicemalfunctions were noted. In all cases,the perforationwas sealed.

Table 4 Summary Table N occurrences JOSTENr deployed successfully 52/52 (100%) Perforation closed/vessel sealed 41/41 (100%) In-hospital MACE Death 0 Emergent CABG 0 a-wave Mi 0

Table 5 Patient Demographics subjects' N=41 Occurrences (%) Not reported Average Age, years 65.2 1 Male 26(65.0%) 1 Hx of MI 23(59.0%) 2 Hx of CAD 30(75.0%) 1 Hx of CABG 11 (27.5%) 1 Hx of PTCA 12(30.8%) 2 Hx of CHF 2(6.4%) 10 Hx of HTN 11(36.7%) 11 Angina 41(100%) CCS Class IAl 6(16.7%) 5 CCS Class III/IV 30(83.3%) 5 Diabetes 6(23.1%) 15 Proceduralforms were never receivedfor 5 of the total 46 cases reportedto JOMED. No informationhas been received regardingthese cases.

Table 6 Procedural Information N=41 subjects N occurrences Index procedureelective 38/40 (95.0%) Index procedureemergent 2/40(5.0%) JOSTENr indication Perforation 37(90.2%) Others: Aneurysm 1 Fistula 2 Rescue after embolizedstent I Native vessel 33(80.5%) SVG 8(19.5%) Average numberof stents used 1.3 (range: 1-3) JOSTENr deployed successfully 52(100%) Perforation closedivessel sealed 41 (100%)

Table 7 In-Hospital MACE N=41 subjects N occurrences Death 0 Emergent CABG 0 0-wave MI 0 1

Final 9 Jan 01 7 9-77 Table 8 Procedural Complications N=41subjects N occurrences Patientsexperiencing any complication 14(34.1%) ProceduralComplications' Pericardialeffusion 9(22.0%) Tamponade 5(12.2%) Pericardiocentesis 6(14.6%) Cardiacarrest 1(2.4%) Hypotension 5(12'.2%) Cardiogenicshock 4 (9;8%) Bradycardia 4(9.8%) fidlcomplications occurred in the cardiaccatheterization laboratory prior to JOSTENT' implantation, except for a singleout of labeffusion that progressed to tamponadeand required emergent re-PTCA with placement of a second JOSTENTOthat sealed the perforation.

Table 9 Complications at Follow-up Complication N occurrences Targetvessel/lesion revascularization (TVR/TLR) 4 TVRonly 1 MyocardialInfarction (Ml) 3 Non-Q-waveMl 2 Occlusionof the targetlesion' 2 Revascularization' 1 Nofurther information was provided.

7.4 Conclusions JOSTENTO The clinicaldata from a small retrospective suggestthat the CoronaryStent study JOSTENTO Graft can safely be deployed in coronaryarteries to seal free perforations. Use of the CoronaryStent Graft is not associatedwith increased riskscompared to conventionaltreatment of perforations. 8.0 INDIVIDUALIZATION OF TREATMENT The risks and benefitsdescribed above should be carefullyconsidered for each patient before JOSTENT9 use of the CoronaryStent Graft. Patient selectionfactors to be assessedshould includea judgment regardingrisk of prolongedanticoagulation. Stenting is generally avoided in those patientsat heightenedrisk of bleeding(e.g. those patientswith recentlyactive gastritisor pepticulcer disease).

8.1 Use in Special populations The effectiveness of this device for any use has not been demonstrated. The JOSTENT9 safety of the CoronaryStent Graft has not been establishedfor patientswith any of the followingcharacteristics: " Patientswith unresolved vessel thrombus at the lesion site. " Patientswith coronaryartery reference vessel diameters <2.75 mm. " Patientswith lesions located in the unprotectedleft main coronaryartery, ostial lesions,or lesions locatedat a bifurcation. " Patientswith diffusedisease of poor outflow distal to the identifiedlesions. " Patients with recentacute myocardial infarction where there is evidence of thrombusor poorflow. " Patients with more than two overlapping stents due to risk of thrombusor poorflow. The safety and effectivenessof using mechanicalatherectomy devices, (directionalatherectomy catheters,rotational atherectomy catheters), or laser angioplastycatheters to treat in-stent stenosishas not been established.

Final9 Jan01 8 9.0 HOW SUPPLIED STERILE: This device is sterilized with ethylene oxide. It is intended for single use only. Non-pyrogenic. Do not use if package is opened or damaged. JOSTENT* CONTENTS: One (1) CoronaryStent Graft on StentHolder. One (1)Instructions forUse Manual. STORAGE: Storein a cool,dry, dark place. 10.0 OPERATOR'S MANUAL

10.1 Inspection Prior to Use Carefullyinspect the sterile package before opening. It is not recommended thatthe product be used afterthe "Use BeforeDate". If the ofthe sterile package has been compromised Date" integrity priorto the product "Use Before (e.g.,damage ofthe package), contact your local JOSTENT'* CoronaryStent Graft Representative for return information. Do notuse ifany defects are noted.

10.2 Materials Required

Quantity Material Appropriateballoon dilatation catheter(s). fHighpressure, non-compliant; See Table1 - DeviceSpecifications) Appropriateguiding catheter(s). (See Table 1 - DeviceSpecifications) 1 20 cc syringe He arinizedNormal Saline 1 0.014inch x 300 cm guidewire 1 Rotatinghemostatic valve Contrastmedium diluted1:1 with Heparinized normal saline 1 Inflationdevice 1 Torquedevice ý--Optional Three-waystopcock

10.3 Stent Mounting

Step Action 1 Usingaseptic techniques, remove thestent from itssterile package and placeit onto thesterile field. Rinse the stent and thestent holder with sterile, heparinized saline. 2 Preparethe delivery balloon catheter system on whichthe stent will be mounted accordingto the manufacturer's instructions. Filla 20 cc syringewith 5 cc ofcontrast/saline -3mixture (1:1). 4 Attachto delivery catheter and gentlyinflate with 2-3 atm whilemoistening the surface witha salinesolution. Note: Any coatingon thedelivery PTCA cathetermust be removed priorto mounting the stent.The coatingof the PTCA catheteris removed by wipingwith a compress soaked inan alcoholsolution. 5 Purgethe balloon and applyconstant negative pressure to the catheter. 6 Pass thestent holder (on which the stent is mounted) over the balloon, making sure thestent is precisely positioned over the balloon, between the two markers 7 While gentlyholding the stent,remove the plastictube, leaving the stentin place. Note:Do not inadvertentlyremove the stentfrom Itscorrect position over the balloon. 7a Inserteither the stiffening wire that is provided with the PTCA catheteror a guidewire intothe guidewire lumen, before starting tocrimp the StentGraft. This will protect the lumen ofthe PTCA catheter. 8 and proximal,crimp the stent to the balloon.Turn theballoon Starting900 distally working by and continuecrimping the stent on tothe device until itis securely fixed. Final9 Jan 01 9 8a To verify adherence, hold the catheter and attempt to dislodge the stent from the balloon using the thumb and index finger. 8b Visually inspect the stent to ensure that it is centered on the balloon and that the stent struts are not protruding away from the balloon. If there are any protruding struts, the stent. If the protruding struts remain or the stent is kinked,DO NOT attemptre-crimp to use the stent. 9 Release the negative pressure to the balloon. 10 Detach syringe and leave a meniscus of mixture on the hub of the balloon lumen. 11 Prepare inflation device in standard manner and purge to remove all air from syringe and tubing._ 12 Attach inflation device to balloon directly insuring no bubbles remain at connection. 13 Leave on ambient pressure (neutral position). Note: Do not pull negative pressure on inflation device after balloon preparation and prior to delivering the stent. 14 Moisten the stent with heparinized saline by submerging the stent into a sterile bowl containing the solution, Note: Do not use gauze sponges to wipe down the stent as fibers may disrupt the stent. 15 Visually inspect the stent to insure the stent is place within the area of the proximal and distal balloon markers. 16 Check the integrity of the stent attachment on the delivery system by gently running the stent segment through the thumb and finger. If not intact, contact your JOSTENr Coronary tent Graft Representativeand return the unused deviceto JOMED5.

10.4 Delivery Procedure

Step Action 1 _ Prepare vascular access site accordingto standard PTCA practice. 2 Maintain neutralpressure on inflationdevice. Open rotatinghemostatic valve to allow for easy p ssage of the stent. 3 Ensure guidingcatheter stabilitybefore advancingthe stent delivery system intothe coronaryartery. 4 Carefullyadvance the stent deliverysystem intothe hub of the guidingcatheter. 5 Note: If physicianencounters resistance to the stent delivery system prior to exiting the guidingcatheter, do not force passage. Resistancemay indicatea problemand may result in damage to the stent if it is forced. Maintainguidewire placement across the lesion and remove the stentdelivery systemas a single unit. (See Section5.3 Removal- Precautions.) -Stent/System 6 Advance deliverysystem overthe guide wire to the target lesionunder direct fluoroscopicvisualization. Utilize the proximaland distal radiopaquemarkers on the balloonas a referencepoint. If the positionof the stent is not optimal, it shouldbe carefullyrepositioned or removed. (See Section5.3 - Stent/SystemRemoval Expansionof the stent should not be undertakenif the stent is not-Precautions.) properlypositioned in the target lesion segmentof the vessel. 7 Optimal stent placement requiresthe distal end of the stent to be placed approximately 1 mm bey nd the distalend of the lesion. 8 __Sufficiently tighten the rotatinghemostatic valve. Stent is now ready to be deployed.

10.5 Deployment Procedure

Step Action 1 Gently deploy the stent by slowly inflatingthe balloonto a minimumof 14 atm to expand the stent. Note: Refer to balloon catheterlabeling and Table 1 for the proper inflationpressure. Do not exceed Rated BurstPressure or expand stent beyond5.0 mm. 2 Maintain inflationpressure for 15-30 secondsfor full expansionof the stent. 3 Note: Under-expansionof the stent may resultin stent movement. Care must be taken to properlysize the stent to ensure the stent is in full contactwith the arterialwall upon deflat on of the deliverysystem balloon. Final9 Jan 01 10 .30 10.6 Removal Procedure

Step Action 1 Deflate the balloon by pullingnegative pressure on the inflationdevice. Allow adequate time, at least 15 seconds,for full balloondeflation. Longer balloonsmay require rn re time for deflation. 2 Fullyopen the hemostaticvalve. 3 Maintain positionof guidingcatheter and guidewireto prevent it from being drawn into vessel. Very slowly,withdraw the balloonfrom the stent maintainingnegative suction, allowingmovement of the myocardiumto gently dislodgethe balloonfrom stent. 4 Tightenthe hemostaticvalve. 5 Repeat angiographyand visuallyassess the vessel and the stent for proper expansion. Note: The use of IVUS is stronglyrecommended to ensure complete appositionof the stent graftto the vessel wall. 6 A secondballoon inflation may be requiredto insureoptimal stent expansion. In such instances,a non-compliant,high-pressure balloon of adequate size (the same size as the stent deliverysystem balloonor larger) and length may be usedto accomplishthis. Note: In smaller or diffuselydiseased vessels, the use of high ballooninflation pressuresmay over-expandthe vessel distalto the stent and could resultin vessel dissection. 7 The final internalstent diameter shouldbe equalto or slightlylarger than the proximal and distal referencevessel diameters. 8 Repeat angiographyand, if possible,IVUS, to evaluateand determine procedure statusor termination. Note: Should the need arise for placementof a secondstent to adequatelycover the perforationlength, placement of the stent most distalin the artery should be done prior o placem nt of the proximalstent, if possible. 9 Note: Observationof the patient and angiographicevaluation of the stent site should be performedperiodically within the first 30 minutesafter stent placement

Final9 Jan 01 10. 7 in vitro Information Table 10 Expanded Stent Diameter (mm) and Length (mm) Chart JOSTENT'9 CoronaryStent Graft Expanded 2.75- 5.0rnm thickness: 0.To -mm -Wall 0 Length Profileunexpanded 2.20mm (mm) (mm) Crimpedto a profile: 1.60mm Articlenumber: 010CGO9 2.5 8.8 3 8.4 3.5 7.8 Length:9.0 4 7.4 0 2.75-5.0mm 5 <7.4

Articlenumber:OIOCG12 2.5 11.8 3 11.5 3.5 11.1 Length:12.0 4 9.4 2.75-5.0mm 5 <9.4

Articlenumber:010CG16 2.5 15.0 3 14.7 3.5 14.4 Length:16.0 4 11.9 0 2.75-5.0mm 5 <11.9

Articlenumber:010CG19 2.5 18.2 3 18.0 3.5 17.3 Length:19.0 4 15.9 0 2.75-5.0mm 5 <15.9

Articlenumber: 010CG26 2.5 24.6 3 24.3 4 22.2 Length:26.0 5 <22.2 0 2.75-5.0mm

Note:Do notexceed ratedburst pressure as specifiedon productlabel as thismay resultin a rupturedballoon with possible intimal damage and dissection. Note: The nominalin vitro device specification does nottake into account lesion resistance. Note: The lengthof the PTFE foilis shorter than the reported stent length. After expansion of thestent, the PTFE foilmay be up to 1.6mm fromthe each end of thestent graft. The covered lengthof the stentedarea may be up to3.2 mm smallerthan the stent length. This information must be consideredwhen choosingan appropriatelysized stent graft. Note: Do notexpand thestent beyond 5.0mm.

Final9 Jan 01 12 1ý;,- Warranty and limitation of liability JOMED GmbH guarantees that this product has been manufactured, sterilized and packaged in compliance with International Quality Standards for medical devices. Each product is individually tested before it is released for packaging JOMED GmbH will replace any device, which in its opinion was defective at the time of shipment and if defects which were caused during manufacturing or packaging are immediately brought to the attention of JOMED GmbH or its distributors. This warranty is exclusive and in lieu of all other warranties, whether expressed or implied, written or oral, including, but not limited to any implied warranties of merchantability or fitness.

As a result of biological differences in individuals, no product is 100% safe under all circumstances. Due to this fact and since JOMED GmbH has no control over the conditions under which the device is used, the diagnosis of the patent, methods of administration, or its handling after the device has left our possession, JOMED GmbH and its distributors do not guarantee either a good effect or against a poor result following its use. JOMED GmbH and its distributors shall not be liable for any incidental or consequential loss, damage or expense arising directly or indirectly from the use of the device. JOMED GmbH and its distributors shall not be liable for damages arising from resterillization or reuse of the product.

Final 9 Jan 01 13 33