Abbey

Instructions for Use of The Spanner TM

and the SurveyorTM

Caution: Federal (USA) law restricts this device touse by or on the order of a physician.

DEVICE DESCRIPTION OF THE SPANNER T ANDACCESSORIESThe SpannerTM Temporary Prostatic Stent ("the Spanner") isa sterile, single use device made of silicone elastomerpositioned in the prostatic urethra, extending from thebladder to the proximal side of the external sphincter (Figure1, A). The interior lumen provides a conduit for urine toflow from the bladder to the external sphincter duringurination.

Figure 1: Spanner Stent (positioned in prostatic urethra)

B -Silicone Balloon

C -Distal Anchor Device Tether

E- Retrieval Tether

The Spanner is inserted and positioned tactilely using adetachable insertion tool. The stent is held in the bladder byan inflatable balloon (B) on its proximal end and a soft distalanchor (C) on the distal end. The distal anchor is attached tothe stent by the device tethers (D). The tethers traverse theexternal sphincter, with the anchor positioned on the distalside of the sphincter to prevent migration toward the bladder,while allowing normal sphincter function to occur. The stentis removed using the retrieval tether (E) which provides forthe deflation of the balloon and withdrawal of the stent.

Spanner size selection is enabled by the use of an accessory,the Surveyor urethral measurement device. The stent andinsertion tool are provided together in a sterile package. TheSpanner is available in 20F diameter, 6 sizes (lengths 4, 5, 6,7, 8, and 9 cm), and straight or coud6-tip versions.

SurveyorThe Surveyorrm (Figure 2) is designed to assess the length ofthe urethra from the bladder neck to the distal side of theexternal sphincter in order to select the appropriate Spannersize. The Surveyor is provided with a coud6-tip. TheSurveyor is sterile and packaged separately.

The Surveyor consists of an inflation tube (Figure 2, A) witha balloon (B) on the proximal end and a hand piece (C) onthe distal end. A lumen extends from an inflation portstopcock on the hand piece to the balloon, and is used toinject fluid to inflate the balloon. A short probe (D) encirclesthe inflation tube and slides along the tube length betweenthe balloon and a stop (F). A probe wire (E) is attached to theprobe tip; it extends along the length of the Surveyor throughthe stop and wire guide (G), where it is attached to a probewire handle (H).

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Figure 2: Surveyor Device

D -Prob Tip

. A -nflatio Tube

F -Stop.-.

C - Hand Piece

[ 4 /G -Wire GuideE - Prob Wirej D't . approprite Spanersiz

H - Probe Wire Handle -b-

INDICATIONS FOR USEThe Spannerr- is intended for temporary use (up to 30 days)to maintain urine flow and allow voluntary urination inpatients following nminially invasive treatment for benignprostatic hyperplasia (BPH) and after initial post-treatmentcatheterization,

CONTRAJNDICATIONSThe Spanner is contraindicated for use in patients with:

* Positive urine culture or active urinafly tract infection,* History of symptomatic urinary tract disease such as

urethral stricture, bladder stones, or other significanturological conditions (e.g. gross hematuria) that couldaffect the function ofthe stent,

* Surgery altering the normal uro-genital anatomy orabnormal urethral anatomy that affects the function ofthe lower urinary tract, or

* A prostatic urethral length less than 4 cm or greaterthan 9 cm (comboined length from the top (proximalside) ofthe bladder neck to the bottom (distal side) ofexternal sphincter).

PRECAUTIONS* Improper selection of device size could result lin

acute urinary retention (AUR), device migration,Incontinence, or patient intolerance.

* If the device migrates or clotting occurs, AIUR maydevelop during use of the Spanner.

* The Spanner and Surveyor are to be used only by orunder the direction of a physician who is qualifiedby training and experience to use the device.

* Appropriate patient education, training, andmonitoring by a qualified health care professionalare required for safe patient use.

* Safety and effectiveness In patients with median lobeenlargement, bladder or pelvic tumors, or priorpelvic irradiation therapy has not been established.

* The Spanner has not been evaluated for use withMRI. If a MRIi is needed, the Spanner should beremoved.

* Safety and effectiveness has not been evaluated foruse immediately following treatment withtransurethral microwave thermotherapy (TUMT)without prior catheterization during the initial post-treatment period.

* The Spanner and Surveyor are packaged sterile andfor single use only. The devices should not be re-

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sterilized. Re-sterilization may degrade devicematerials resulting in device failure.

· Sterile water should be used for balloon inflation.Use of saline or ionic solutions may compromiseballoon drainage at the time of removal.

· Do not use petroleum based lubricants with thedevice. Use of these lubricants may degrade devicematerials resulting in device failure.

· The Spanner patient contact surfaces are siliconerubber. If your patient has a known allergy orsensitivity to silicone, do not use the Spanner.

ADVERSE EVENTSMen enrolled in this evaluation were post-TUMT patients.The events reported may reflect the cumulative effects thatcharacterize the TUMT healing process as well as thepresence of the Spanner. The Spanner clinical trial included100 subjects who used the Spanner to improve their urinarysymptoms and urine flow after removal of their post-treatment urinary catheter.

There were 658 adverse events reported during the course ofthe study; 385 events were reported by 99 Spanner subjectsand 273 events were reported by 80 Standard of Care (SOC)subjects.

There were 5 serious adverse events reported during thecourse of the study. The four events in the Spanner groupwere: gross hematuria due to initiating anticoagulationtherapy, congestive heart failure, and preexisting abdominalaortic aneurysm (all unrelated to the device), and urinarytract infection requiring hospitalization (possibly related tothe device). The one serious adverse event reported in theStandard of Care group was congestive heart failure. Therewere no deaths reported.

Table I shows the number and percentage of post-TUMTSpanner subjects that experienced an event at least once forevents that occurred in at least 3% of the the Spannersubjects. All 100 Spanner subjects were included in theanalysis.

Mieturition Burning 69 (69.0%) 70Bleeding/Hematuria 61 (61.0%) 68Urinary Frequency 44 (44.0%) 47UrgencyPerineal Pain 26 (26.0%) 29Bacteriuria 21 (21.0%) 23Pain/Discomfort/Spasm 19 (19.0%) 21Symptomatic UTI 15 (15.0%) 16Urinary Retention 10 (10.0%) 12'

Urinary Retention 5 ( 5.0%)with no reportedmigration orclottingUrinary Retention 3 (3.0%)associated withmigrationUrinary Retentions 2 (2.0%)associated withclotting

Urinary Incontinence 8 (8.0%) 8Pain -Trauma 7 (7.0%) 8ActivatedIrritation of 6 (6.0%) 6Bladder/Urethra fromdevice contactUlceration/Trauma of 4 (4.0%) 4Urethra/BladderEjaculation Failure 4 (4.0% ) 4Dyspaieunia -Painful 4 (4.0% ) 4SexElevated PVR 3 (3.0%) 3Urinary hesitation 3 (3.0%) 3* This includes two retention events that occurred after Spannerremoval.

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Bladder and urethral cystoscopy revealed no significantdifferencea in findings between the treatment and controlgroups.

Other urological adverse events that occurred in less than 3%of subjects in the investigation included: difficulty inmicturition, post void dribble, urethral irritation, pmuritus,mucosal tingling, migration not associated with retention,Spanner expulsion, Foley expulsion, bladder calculus,hemospermia, epididymitis, penile swelling, phimosis, penilepain, ejaculation disorder, testicular pain, bladder discomfort,and urethritis. The majority of adverse events (>75%) forboth groups occurred during Weeks 1-4 followingrandomization. Adverse events that occurred followingremoval of the Spanner included: bleeding/hematuria,urinary/frequency/urgency, urinary retention, elevated PVR,perineal pain, pain/discomfort/spasm, micturition bumning,bacteriuria, and symptomatic UTt.

To assess the severity of the reported events, urologicaladverse events that required treatment were reviewed. Ratesof urological adverse events requiring treatment werecomparable for the Spanner and SOC subjects. Table 2 showsthe number and percentage of Spanner subjects thatexperienced an event which required treatment for events thatoccurred in at least 3% of the the Spanner subjects. All 100Spanner subjects were included in the analysis.

Ursinary ~Retetion fUr ogca Adv0.0% 12'qwi

reprtemiraton Trealtmenng

BUtriuarya 16eto sscae (36.0%) 1

repoted migration s lotn

Urinary Retentions associated 3 (3.0%)

with clotting

Micturition Burning 9 (9.0%) 9

Pain/Discomfort/Spasm 7 (7.0%) 8

Urinary Frequency Urgency 5 (5.0%) 5

Perineal Pain 5 (5.0%) 5* This includes two retention events that occurred after Spanner

removal.

Other urological adverse events requiring treatment thatoccurred in less than 3% of subjects in the investigationincluded: bleeding/hematuria, elevated PVR, migration notassociated with retention, Foley expulsion, irritation ofbladder/urethra from device contact, epididymitis, and

testicular pain.

SUMMARY OF CLINICAL STUDIESPurpose

Safety and effectiveness of The Spannert m

TemporaryProstatic Stent ("the Spanner") was evaluated in aprospective, randomized, multi-center clinical investigation.

Methods

The investigation compared use of the Spanner to a Standardof Care (SOC) control group during the post-TUMT recoveryperiod. Patients were randomized after the Foley catheter wasremoved, 3 -1I0 days post-TUMT, and successful completi onof a voiding trial. The Spanner:SOC randomization ratio was1:1I for the first 147 enrolled subjects and 2:1 thereafter.Patients in the Spanner group used the Spanner to managelower urinary tract symptoms (LUTS) and bladder emptyingforsa period of 28 days after removal of their post-treatmentFoley catheter. Patients in the SOC group were sent home

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with no catheter or stent after removal of their post-treatmentFoley catheter, as this is the current standard of care. A totalof 186 patients were enrolled in the investigation at nineclinical centers in the United States. Primary study endpointswere reduction in post-void residual level (PVR) andreduction in LUTS (as indicated by the International ProstateSymptom Score- 'IPSS'). The investigational planhypothesized that the reduction in PVR levels in the Spannergroup would be non-inferior to that in the SOC group andthat the reduction in IPSS in the Spanner group would besuperior to that in the SOC group. Adverse events and othersecondary endpoints were monitored. Study subjects werefollowed at 1, 2, and 4 weeks during the Spanner indwellingperiod and I and 4 weeks after the point of Spanner removal.

Results

A total of 186 subjects were enrolled and randomized at nine(9) clinical centers, with 100 subjects (54%) randomized intothe Spanner group and 86 (46%) into the Standard of Caregroup. Table 3 depicts the number of subjects participatingin each follow-up evaluation.

Visit 3 (7 days post Insertion) 89 81

Visit 4 (14 days post Insertion) 86 8 1

Visit 5 (28 days post Insertion 82 78and Spanner Removal)

Visit 6 (7 days post Removal) 82 78

Visit 7 (28 days post Removal) 82 77

The primary efficacy endpoint of the trial, IPSS score, wasanalyzed by comparing the mean at visits 3 and 4 to thebaseline value, and computing a change score (using lastvalue carried forward for missing data). All 100 Spannerpatients and 86 Standard of Care patients were included inthe analysis, with an improvement from baseline of 7.28points in the Spanner group and 4.42 points in Standard ofCare. The Spanner group was statistically improvedcompared to Standard of Care with a difference of 2.86points (p=0.019).

The primary safety endpoint, post void residual (PVR), wasanalyzed by comparing the mean at visits 3, 4 and 5 to thebaseline value, and computing a change score (using lastvalue carried forward for missing data). All 100 Spannerpatients and 86 Standard of Care patients were included inthe analysis, with a mean decrease (improvement) frombaseline of 6.5 ml in the Spanner group and a mean increaseof 28.6 ml in the Standard of Care group. The Spanner groupwas significantly improved compared to Standard of Care(p=0.001).

IPSS and PVR values presented by visit (Table 4 and Table5), demonstrate superiority (p<0.05) in the Spanner groupversus Standard of Care at Visits 3 and 4 for PVR and atVisit 3 for IPSS. All 100 Spanner patients and 86 Standardof Care patients were included in the analyses.

(Area intentionally left blank)

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Visit I (Baseline) 22.7+/- 5.4 22.1+/- 5.0 N/A

(10,34) (13,35)

Visit 3 -6.6+/- 9.1 -3.6+/- 7.3 0.047

(change from Visit 1) (-27, 14) (-31, 13)

Visit 4 -8.0+/- 9. 1 -5.3+/- 8.2 0.084

(change from Visit 1) (-30, 16) (-35, 12)

Visit 5 -9.1+/- 9.5 -7.7+/- 7.9 0.290

(change from Visit 1) (-29, 15) (-35, 10)

Visit 6 -11.9+/- 9.1 -9.8+/- 8.0 0.179

(change from Visit I) (-30, t0) (-35, 6)

Visit 7 -14.1+/- 8.9 -12.3+/- 7.8 0.234

(change from Visit 1) (-31, 9) (-35, 2)

* Multiply adjusted using the permutation resampling methodof Westfall and Young (1993)

( 0, 347) ( 0, 641)]Visit 2 (Baseline) 60.0+/-62.3 60.3+/-88.9 N/A

( 0, 291) ( 0,641)Visit 3 -7.7+/-63.0 32.2+/-89.8 0.001(cha nge from Visit 2) (-166, 199) (,365, 511)Visit 4 -5.0+/-70.4 40.0+/-93.3 0.001(change from Visit 2) (-190, 214) (-328, 417)Visit 5 -6.7+/-65.6 13.6+/-80.6 0.099(change from Visit 2) (-190, 263) . (-341, 275)Visit 6 9.1+/-71.3 12.8+/-76.8 0.736

(change from Visit 2) (-190, 204) (-337, 229)* Multiply adjusted using the permutation resampling methodof Westfall and Young (1993)

PATIENT COUNSELING INFORMATIONPatient counseling is the responsibility of the treatingphysician. AbbeyMoor Medical provides a PatientInformation Booklet to assist the physician in discussing The

Spanner and Surveyor with the patient. It is recommendedthat the subjects in this book including the insertion andremoval of the Spanner, the risks, sexual activity, and otheroptions be discussed with the patient. It is AbbeyMoorMedical's recommendation that the Patient InformationBooklet be provided to the patient in a timely manner.

HOW SUPPLIEDThe Spanner and Surveyor are packaged and sold separately.

One (1) Spanner is packaged sterile in a peel-away pouch

with Instructions for Use (IFU) and an Emergency Removal

Card included.

One (1) Surveyor and Spanner Selector Card are packagedsterile in a peel-away pouch with an IFU included.

The Spanner and Surveyor are provided ethylene oxide (EO)

sterilized.

Materials required but not included:

- M Ip cc Luer-tip syringe- Water based lubricant (i.e. KY Jelly)- Lidocain e Jelly- S terile Water

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INSTRUCTIONS FOR USECaution: Before using any sterile packaged product,carefully inspect the package and device for any damagewhich may compromise sterility or use.Use the Surveyor to select the appropriate sizeSpannerThe appropriate Spanner size is determined using theSurveyor, a tool designed to assess the distance from thebladder neck to the distal side of the external sphincter,which corresponds with where the Spanner resides in situ.

I. Lubricate the tip of the Surveyor with a water solublelubricant (e.g., sterile lubricating jelly or topicalanesthetic).

2. Inject a topical anesthetic into the urethra.3. Insert the Surveyor into the urethra and advance it until

the proximal tip is located in the bladder.4. Inject 5cc sterile water and close stopcock.

Caution:· Failure to close the stopcock valve will allow the

balloon to deflate, potentially resulting in aninaccurate Spanner size selection.

· Use the recommended inflation volume to ensureaccurate selection of Spanner size.

5. Apply gentle traction on the Surveyor to seat theballoon on the bladder neck.

6. Ask the patient to relax while continuing to applygentle traction to the Surveyor, then advance the probetip until it gently abuts the patient's external sphincter.

7. Confirm sphincter location by repeating step 6.8. Once confirmed, the Spanner size is determined by

comparing the distance between the wire guide and theprobe wire handle with the Spanner selector card(Figure 3). This distance represents the distance fromthe bladder neck to the bottom of the external sphincter.The Spanner selector card indicates the appropriate sizeto use.

Caution: If the probe wire handle does not indicate a size,the patient is not a candidate for receiving the Spanner.

Figure 3: Spanner Selector Card and Device Size Table(Note Spanner Size 8cm selection shown)

Place card against wireguide as shown

Proximal edgeof probe wire "

9. aFolown ie. seetooe h socc n at11. ihat vorDevice Size

4 cm-~ 5 cm

6 cm7era8 cm9 cm

9. Following size selection, open the stopcock and wait 15seconds until the balloon is completely drained.

10. Withdraw the Surveyor.

Prepare the Spanner

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(Refer to Figure 4 for a detailed diagram of the Spanner andInsertion Tool components.)

1. Separate the Spanner stent from the Insertion Tool.2. Verify that the balloon plug (A) is properly seated in

the balloon plug port.3. Partially fill the stent lumen with sterile lubricant.4. Replace the stent onto the insertion tool.5. Conduct a balloon inflation pre-test as follows:

a. Inject approximately 5cc sterile water into theinflation port.

Caution: If the balloon does not fully inflate, do notuse the device.

b. Pull the black retrieval tether (B) to drain theballoon.

c. Massage the balloon (C) lightly to remove theresidual water and fully replace the balloon plug(A).

Figure 4: The Spanner and Insertion Tool Detail

C -Balloon

C-BalloonA--Tube.

F-Push Cup

(Note black mark)

E-AnchorSle

D - Dial Anchor

B-RelrievalTether

H -Hand piece

Detail of The Spanner stentwithout the Insertion Tool

-Laer Inflation PorA

Detail of the Insertion Toolwithout The Spanner

6. Retract the distal anchor sleeve (E) until the push cup(F) is visible. Fill the anchor sleeve lumen withlubricant.

7. Insert the tip of the distal anchor (D) under the blackmark on the push cup (F).

8. Wrap the distal anchor around the insertion tool tube(I).

9. Advance the wrapped anchor into the anchor sleeveuntil the anchor is covered.

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10, Align the black retrieval tether along the body of theinsertion tool. Be very careful to ensure thatthe blackretrieval tether is not wrapped around the body of theinsertion tool to avoid inadvertent or premature removalof the balloon plug.

The Spanner is now prepared for insertion.

Insert the Spanner

Caution:Proper placement of the device and correct ballooninflation volume are essential for device function.Misplacement or incorrect inflation volume mayresult in inadequate stenting of the prostate. If thisoccurs the patient may experience difficulturination, increased post void residual (PVR) orAUR. Incontinence may occur if stent extendsthrough the external sphincter.

*The balloon must be in the bladder prior toinflation. Inflation of the balloon while in theurethra may be painful.

* Sterile water should be used for balloon inflation.Use of saline or ionic solutions may compromiseballoon drainage at the time of removal.

* Do not use petroleum based lubricants with thedevice. Use of these lubricants may degrade devicematerials resulting in device failure.

I1. Advance the Spanner slowly into the urethra until theballoon is positioned in the bladder. Do not useexcessive force to insert the Spanner. If unexpectedresistance is encountered, do not continue insertionwithout first determining the cause of the resistance andtaking remedial action.

12. Use a luer syringe to inject 5cc sterile water into theinflation port (G).

13. Apply gentle traction to position the balloon in thebladder neck.

14. Release the anchor by holdine the metal luer (G) steadywhile withdrawing the plastic hand piece (H). You mayfeel the anchor release from the insertion tool.

Caution: Pushine the metal luer to release tieanchor will incorrectly position the Spanner in theurethra.

15. Continue to withdraw the insertion tool using the plastichand piece. The Spanner should deploy easily from theInsertion Tool. If separation of either the distal anchoror the hand piece does not occur with gentle traction thedevice should be removed by pulling the black tether,waiting 15-20 seconds to allow the balloon to deflate,and then withdraw the device.

16. The black retrieval tether may be left extended beyondthe meatus. If left extended, it should be trimmed 2"beyond meatus with penis on stretch to compensate forthe possibility o f erectile function and to preventretraction of tether.

Discharge the Patientl. Conduct a trial void to verify patient can urinate

adequately.2. Instruct the patient not to pull on the black retrieval

tether as this could deflate the balloon and dislodge theSpanner.

Caution: Pulling the black tether may result in thepatient experiencing an AUR event.

3. Instruct the patient on the signs of developing retentionand other potential adverse events. At the onset ofrelevant symptoms the patient should consult hisurologist or caregiver.

4. Provide the patient with emergency contact informationand Emergency Removal Card. Instruct the patient that

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if he requires emergency care the caregiver must beinformed that the patient is wearing The Spanner.

5. Instruct the patient that removal of The Spanner shouldbe performed by or under the supervision of aphysician.

Remove The SpannerI. If tether is indwelling, it may be beneficial to have the

patient urinate immediately prior to device removal tohelp position the retrieval (ether near the meatus.Retract the tip of the penis slightly to locate and graspthe retrieval tether. Note: If the retrieval tether cannotbe located manually, urethroscopy may be required tolocate and grasp the retrieval tether.

2. Remove the device by gently pulling on the blackretrieval tether until you feel the plug release from theballoon then stop pulling. Wait 15-20 seconds to allowballoon to deflate.

3. Resume pulling on the black rebieval tether until stentis removed. Do not use excessive force during deviceremoval. If unexpected resistance is encountereddetermine the cause of the resistance and take remedialaction.

Caution:· If excessive resistance is felt during Spanner

removal, balloon deflation may not haveoccurred. Removal of the device should becompleted under cystoscopic guidance.

* If balloon rupture occurs during removal,cystoscopy should be performed to assure that allballoon fragments have been removed from theurinary tract.

4. After use, this product may be a potential biohazard.Handle and dispose of in accordance with acceptedmedical practice and applicable laws and regulations.

PATIENT INFORMATIONA Patient Information Booklet is available to assist thephysician in counseling the patient about this device. PatientInformation Booklets are provided with the initial deviceorder and additional copies are available from AbbeyMoorMedical. A patient Emergency Removal Card is includedwith this IFU.

For additional information contact:AbbeyMoor Medical, Inc.501 East Soo StreetParkers Prairie, MN 56361 USA1-888-528-9073 FAX 1-218-3386710

International Symbols GlossaryA Caution, Consult Accompanying

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Manufacturer

EU Authorized Representative

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Batch Code

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