A Patient'sG uide to

IP'LumbarSpinal

Stenosis

X*STOPInterspinous

Process

Decompression

This patient information guide is madepossible through cooperation betweenyour physician and St. Francis MedicalTechnologies, Inc. It is not designed as areplacement to professional medical careor advice. Only your surgeon is qualifiedto diagnose and appropriately treat yourpain and related problems.

For more information contact:St. Francis Medical Technologies, Inc.960 Atlantic Avenue, Suite 102Alameda, CA 94501Phone: (510) 337.2600www.sfmt.comDate: 9.16.05

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ST. FRANCIS MEDICAL TECHNOLOGIES, INC

Dear Patient,

This brochure is intended to help you understandthe nature of a medical condition called lumbarspinal stenosis and a new therapy that is avail-able, X STOP Interspinous Process Decompression(IPD).

Your doctor has made this brochure available inorder to answer common questions and to helpyou make an informed and careful decisionabout your treatment.

As you read this brochure, bear in mind that allforms of medical treatment - and particularlysurgery - are highly personal matters.

That means that no matter how common yourmedical condition may be, your doctor willrecommend treatment based on your individualneeds.

There are always risks associated with any typeof surgery. Your doctor will help explain the risksassociated with all treatments discussed in thisbrochure.

This brochure is yours to keep. And we hope thatou've chosen to read it in the comfort of your

home, with family members and as many timesas necessary.

So always remember, if you have any questionsabout your medical condition or the treatmentoptions discussed in this brochure - please askyour doctor.

Table of Contents

Glossary of Terms

Anatomy of the Spine 4

What is Spinal Stenosis ?._ _ 6

Symptoms of Spinal Stenosis 8

What is The XCSTOP System? 14

What is IPD ? 15

The X'STOP' Procedure · _ 17

Preoperative Considerations 20

Possible Complications 21

Postoperative Care 22

X51TOP' IPD: Clinical Study Results -23

Summary 25

Index 27

Glossary of Terms

Analgesic: A drug that alleviates pain withoutcausing loss of consciousness.

Anesthesia: A drug that blocks pain impulsesfrom nerves. With general anesthesia you areunconscious, or asleep. With local anesthesiayou are conscious, or awake.

Artifact: An abnormality in an image resultingin distortion and interference.

CAT or CT Scan (Computerized AxialTomography): A test that uses X-rays andcomputer analysis to create the three-dimensionalpictures of the inside of your body.

Cauda equina syndrome: The cauda equinais a bundle of nerves at the. bottom of thespinal cord. Cauda equina syndrome is severecompression of the cauda equina resulting in lossof bowel or bladder function, loss of sensation inthe buttocks and groin, and weakness in the legs.

Corlcosteroid: A medicine that reduces swelling,or inflammation.

Degenerative: Undergoing degeneration:growing less healthy over time.

Extension: Bending backward, standing upright.

Facet. Surfaces where two vertebrae meet andarticulate (move) forming a joint.

Facetectomyr An operation to remove part ofthe facet. To prevent a degenerated facet frompinching a nerve.

Flexion: Bending forward, or sitting.

Foramen: A natural opening or passage in bonefor nerves and blood vessels.

Foraminotomy: An operation to make theforamen larger. To provide more space for thenerves and blood vessels.

Fusion: An operation to permanently join thevertebrae together.

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Interspinous Ligament: Spinal ligament thatextends from one spinous process to the other.

Interspinous Process Decompression (IPD):An operation in which an implant, called the XSTOP, is placed between your spinous processes.

Interspinous Space: The space between thespinous processes of the vertebrae.

Intervertebral Disc: Tissue found between thebones of the spinal column, called vertebrae. Thediscs help cushion the spine from stress duringeveryday activities (i.e., walking, bending,sitting, etc.).

Lamina: A part of a vertebra. For each vertebra,two lamina connect the pedicles to the spinousprocesses - forming the roof of the spinal canal.

Laminectomy: An operation to remove thelamina. The purpose is to allow more room forthe spinal cord and nerves.

Laminotomy: An operation to remove part of thelamina. This is done to allow more room for thespinal cord and nerves.

Ligaments: A band of tissue linking two bones ina joint.

Lumbar. The lower part of the spine between theribs and hipbones.

Lumbar Spinal Stenosis: A degenerative spinaldisease that causes narrowing of the spinalcanal. This narrowing pinches the nerves andcauses pain symptoms.

MRI (Magnetic Resonance Imaging): A test thatuses magnetic fields to create detailed pictures ofthe inside of your body.

Myelogram: A diagnostic procedure in which adye is injected into the spinal canal before an X-ray is performed. The dye makes the spinal canaland nerve roots easier to see on X-ray film.

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Nerves: Fibers containing nerve cells that sendmessages between the bra in and the rest of thebody.

Nerve Compression: Pressure on a nerve;may cause nerve damage and muscle weakness.

Nerve rooit The start of the nerve as it leaves thespinal cord (and passes through the foramen).

Osteophyte: A bony outgrowth on the edge of avertebra, also known as a bone spur.

Peclicle: A part of a vertebra. It connects thelamina with the vertebral body.

Spinal Canal: The bony channel that contains thespinal cord.

Spinal Cord: A bundle of nerves that carriesmessages between the brain and the rest of thebody.

Spinoius Process: A part of the vertebra. Aspious process protrudles from each vertebra.

Th spinous proces ses create the "bumps" youfeel in the middle of your back.

Spinal Stenoisis: Narrowing of the spinal canal.

Supraspinous Ligament, Spinal ligament thatpasses over and attaches to the tips of thespinous processes.

SpondylOlisthesis: A condition in which onevertebr slips forward in relation to the vetebrabelow it.

vertebra: A bone of the spinal column. Thereare five (5) lumbar vertebrae.

X-rayr A test that uses radiation to producepictures of the inside of the body.

)U-STOPO: A titanium implant that fits betweenthe spinous processes.

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Anatomy of the Spine

Your spine consists of a column of 24 bonescalled vertebrae that extend from your skull downto your hips (Fig. 1). Between the vertebrae arediscs of soft tissue. The vertebrae join togetherlike links in a chain, providing support for yourhead and body while the discs act as cushions,or "shock absorbers." In addition to providingsupport, the spine encloses and protects acylinder of nerve tissues called the spinal cord.The spinal cord is surrounded by a bony channelcalled the spinal canal.Fig. 1

Vertebra

Disc~

Spinous Process> . - -- Interspinous

4

Normally there is space between the spinal cordand the borders of the spinal canal so that thenerves are free and are not pinched (Fig. 2).

Fig. 2 Intervertebral Disc

$/ Nerve Root

Spinal Cnal SpnlNre

Healthy

As we age the ligaments and bone that surroundthe spinal canal can thicken. This thickeningresults in narrowing of the spinal canal, whichis called "spinal stenosis." The spinal cord andnerve fibers that exit the spinal canal (nerveroots) become crowded and pinched due to thisnarrowing. This results in pain and numbness inthe back and legs (Fig. 3).

Fig.3 -

Bulging K N "Trapped'Intervertebral Nerve Root

Disc

Bone ~~~~Ligament(Facet Joint) ("Yellow Ligament')

Stenotic

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What is Spinal Stenosis ?

Spinal stenosis is a narrowing of the spinal canal.Some patients are born with tb is narrowing butmost often spinal stenosis is the result of a cegen-erative condition that develops in people over theage of 50. Spinal stenosis is the gradual resulto aging and'"'wear and tear" on the spine fromeveryday activities.

Degenerative or age-related changes in our bodiescan lead to compression of nerves (pressure onthe nerves that may cause pain and/or damage).(Fig 4).

Fig. 4

Spinous Processes

Nerve Root

A ~~~Vertebrae

Healthy

Spinal Canal

SupraspinousLigament

InterspinousLigament

Intervertebral Discs

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As we age:

* the ligaments of the spine can thicken andcalcify (harden from deposits of calcium)

* bones and joints may also enlarge

• bone spurs, called osteophytes, may form

* discs may collapse and bulge (or herniate)

* one vertebra may slip over another (calledspondylolisthesis)

Fig. 5

"Kissing" SpinousProcesses

"Pinched"

Bulging Ligament

~~~ ~~Bulging

Disc

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Symptoms of Spinal Stenosis

If you suffer from lumbar spinal stenosis you mayfeel various symptoms, including:

• dull or aching back pain spreading to yourlegs

* numbness and "pins and needles" in your legs,calves or buttocks

*weakness, or a loss of balance, and· a decreased endurance for physical activities

Fig. 6 Standing or walking causes symptoms

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Symptoms (cont'd)

Symptoms increase after walking a certaindistance or standing for a time. Symptoms canimprove when you:

* sit

• bend or lean forward (see Figure below)

* lie down, or

* put your foot on a raised rest

Fig. 7 Leaning forward while walking relievessymptoms

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Diagnosing Lumbar Spinal Stenosis

Before confirming a diagnosis of stenosis, it isimportant for your doctor to rule out otherconditions that may produce similar symptoms.In order to do this, most doctors use acombination of techniques, including:

* History - Your doctor will begin by asking youto describe any symptoms you have and howthe symptoms have changed over time. Yourdoctor will also need to know how you havebeen treating these symptoms, includingmedications you have tried.

· Physical Examination - Your doctor will thenexamine you and check for any limitations ofmovement in your spine, problems withbalance, and signs of pain. Your doctor willalso look for any loss of reflexes, muscleweakness, sensory loss, or abnormal reflexes.

* Tests - After examining you, your doctor mayuse a variety of tests to confirm the diagnosis.Examples of these tests include:

X-ray - shows the structure of thevertebrae and the outlines of joints.

MRI (Magnetic Resonance Imaging) -provides a three-dimensional view ofyour back and can show the spinal cord,nerve roots, and surrounding spaces, aswell as signs of degeneration, tumors orinfection.

CAT Scan (Computerized AxialTomography) - depicts the three-dimensional shape and size of your spinalcanal and bony structures surrounding it.

Myelogram - highlights the spinal cord andnerves after a dye is injected into yourspinal column, which appears white on anX-ray film.

Precaution:Radiological evidence of stenosis must becorrelated with your symptoms before thediagnosis can be-confirmed.

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Treatment Options

Once a diagnosis of spinal stenosis isconfirmed, the process of treating the conditionusually begins with a regimen of non-invasive,"conservative" therapy.

Non-surgical Treatment of Stenosis

There are a number of ways a doctor can treatstenosis without surgery, including:•Medications, such as non-steroidal anti-

inflammatory drugs (NSAIDs) to reduceswelling and pain, and analgesics to relievepain.

*Corticosteroid injections (epidural steroids) toreduce swelling and treat acute pain thatradiates to the hips or down the leg. Pain relieffrom an epidural injection may be temporaryand patients are usually advised to get no morethan 3 injections per 6-month period.

*Rest or restricted activity.•Physical therapy and/or exercises to help

stabilize the spine, build endurance andincrease flexibility.

While some patients obtain relief from symptomswith these treatments, others do not.

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So

Surgical Treatment of Stenosas

Decompression

Non-surgical treatments may temporarily relievepain. Mare severe cases of stenosis may requiresurgery.

The mast common surgical procedure for stenosisis a dlecompressive laminectomy sometimesaccompanied by fusion. Often referred to as"unroofing' the spine, this procedure involvesthe removal of various parts of the vertebrae,including:

• the lamina, ais well as the attached ligaments,that cause comprdssion of the spinal cord andnerve roots, and/or

* enlarged facets, osteophytes and bulging discmaterial

The goal of the surgery is to relieve pressure onthe spinal cord and nerves by increasing the areaof the spinal canal and neural foramen.

Other types of surgery to treat stenosis include:

*Lominotomy - only a small portion of thelamina is removed to relieve local pressure onthe spinal cord and nerve roots.

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Surgical Treatment (cont'd)

Fig. 8 Laminectomy Procedure

Bone is removed and spinal cord is exposed

Pre-Op Post-Op

· Foraminotomny - the foramen (the openingthrough which the nerve roots exit the spinalcanal) is enlarged to increase space for thenerves. This surgery can be done alone orwith a laminotomy.

· Facetectomy - part of the facet joint isremoved to increase space for the nerves.

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What is The X-STOP0 ?

The X STOP is a titanium metal implant designedto fit between the spino us processes of thevertebrae in your lower bock. It is designed toremain safely and permanently in place withoutattaching to the bone or ligaments in your back.(Fig. 9).

Warning:The X STOP implant is manufactured froma titanium alloy of metal. Please informyour doctor if you think you are allergic totitanium or titanium alloy.

Fig. 9 K*STOPC OaSpacer

Wings

fig. 9. The oval spacer fits between the spinousprocesses and the wings are designed to preventthe implant from moving.

Caution:The X STOP is manufactured from, a titaniumalloy which is known to produce artifactsif you undergo an MRI exam. if you havean MRI exam, after you have had X STOPsurgery, inform your doctor that youhave the X STOP. Failure to inform. yourdoctor may affect the quality of diagnosticinformation obtained from these scans. TheX STOP is MRI safe.

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63

What is IPD ?

Interspinous Process Decompression (IPD)

IPD is a surgical procedure in which an implant,called the X STOP, is placed between two bonescalled spinous processes in the back of yourspine.

Fig. 10

"Kissing" SpinousProcesses

2d/ "Pinched"Nerve Root

Stenotic

Bulging Ligament

Bulging Disc

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Surgical Treatment with IPD

With IPD surgery there is no removal of bone orsoft tissue. The X STOP implant is not positionedclose to nerves or the spinal cord, but ratherbehind the spinal cord between the bony spinousprocess. (Fig I1t).

Treated with IPD

Ligament

Interspinous CaSOP

Ligament

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The X-STOP0 Procedure

The procedure may be performed in either theoperating room or special procedures room atthe hospital. Using local anesthesia and with thehelp of X-ray guidance, the X STOP implant isinserted through a small incision in the skin ofyour back. Alternatively, your surgeon may electto use general anesthesia.

You will be placed on your side during theprocedure so that you can bend your spine whenthe X STOP is inserted. The surgery to implantthe X STOP typically lasts 45 minutes to an hour-and-a-half. During this time you may be awakeand able to communicate with your doctor.

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56G

Why may XCSTOP® IPD Work?

The X STOP implant is designed to keep thespace between your spinous processes open, sothat when you stand upright the nerves in yourback wiii not be pinched or cause pain. With theX STOP implant in place, you should not need tobend forward to relive your symptoms. (Fig. 1 3).

Fig. 12 Bending forward relieves symptoms

1 8

IPD offers several benefits compared to traditionalsurgery for lumbar spinal stenosis, including:

· the option of local anesthesia

* the potential to be an outpatient procedure

* usually no removal of bone or soft tissue

allowing for potentially quicker recovery

* fully reversible procedure that does not

limit any future non-surgical and surgical

treatment options

Fig. 13 After IPD, you may no longer need tobend forward to relieve your symptoms becausethey may be reduced or gone completely

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Preoperative Considerations

Are you a candidate for the X STOP procedure?

The X STOP is indicated for patients aged 50 orolder who have lumbar spinal stenosis. Adiagnosis of lumbar spinal stenosis should beconfirmed by a doctor with X-ray, MRI or CTscans. The X STOP is indicated for patients withmoderately impaired ability to function, whoexperience relief from their pain symptoms whenbending forward. Patients receiving the X STOPshould have already been under a doctor's careand getting non-surgical treatment for theirsymptoms for at least 6 months. The X STOP maybe implanted at one or two levels of the lumbarspine.

Who should not receive it?

The X STOP should not be used if you have:* an allergy to titanium or titanium alloy*spinal anatomy that would prevent

implantation of the device or cause the deviceto be unstable in your body

* cauda equina syndrome, which is a spinalnerve compression that causes bowel orbladder dysfunction

•bone fractures or a diagnosis of severeosteoporosis

*an infection in your blood or anywhere nearyour lower back where the surgery is planned.

Preparing for Surgery

If you and your surgeon elect to go ahead withX STOP IPD, there are several things you can doto help you achieve the best possible outcomefor your surgery. You can increase the likelihoodof a successful outcome by eating well-balancednutritional meals as far in advance of yourprocedure as possible. Poor nutrition can reducethe body's ability to heal itself.

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Possible Complications

Spinal surgery is not without risk.

Specific information on the rates of complicationsfor the X STOP IPD System and spinal surgeryshould be discussed with your doctor.

Complications that may be associated withX STOP surgery include, but are not limitedto, the following:* implant dislodgement (movement out of

place)* implant not positioned correctly* fracture of the spinous process* foreign body reaction (ex. allergic reaction)* additional surgery, which could include

removal of the X STOP implant* mechanical failure of the implant.Complications related to any type of surgerymay include, but are not limited to, thefollowing:* reactions to anesthesia• heart attack• infection, which could require medication or

an operation• blood vessel damage/bleeding* bruising (hematoma)* pneumonia• blood clots* wound closure problems* spinal cord or nerve damage• pain or discomfort• paralysis· stroke• death

Please consult your doctor about thecomplication rates related to surgery.

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C0

Postoperative Care

You may feel immediate relief from pain followingthis procedure. You may be able to walk the sameday and you may be discharged from the hospitalwithin 24 hours. Although X STOP surgery cantypically be performed on an outpatient basis,your physician may recommend a short hospitalstay.

Following your discharge, physical therapy maybe recommended. Your doctor may ask you toreturn for an examination approximately sixweeks later. While your doctor may recommendsome limitation in your physical activities in theweeks following your operation, you should beable to travel and engage in light activity as soonas you feel able to. Physical activity limitationsmay include:* no bending backward* no heavy lifting* no stair climbing* no sports such as swimming, golf, tennis,

racquetball, running or jogging.

Postoperative medication is generally notrequired. Walking is usually acceptable as longas it is comfortable and does not exceed onehour in duration. Normal activity can usually beresumed with the doctor's recommendation withintwo to six weeks after the procedure.

It is important for you to realize that you haveundergdone a suramcal operation and that youshould'not pa:rtici~pa..te in strenuous activities until

your doctor has indicated you may do so. Youmust follow your doctor's directions carefully in

order to fully recover from your surgery.

If you are planning to have other diagnosticprocedures or treatments, not related to yourXSTOP surgery, please tell your doctor that you

had X STOP surgery.

Caution:It is important to follow your doctor'sinstructions carefully in order to fully recoverfront surgery. Failure to follow postoperativecare recommendations may result inrecurrence of symptoms and discomfort. Astress fracture of the spinous process mayoccur if strenuous physical activity is resumedtoo soon postoperatively.

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6i

X-STOP® IPD: Clinical Study Results

The X STOP IPD System was tested in a carefullycontrolled research study that took place in ninehospitals across the United States. In this study,100 patients with lumbar spinal stenosis hadsurgery with the X STOP device. These patientswere compared to 91 patients who did not havesurgery, but were treated by their doctors in otherways (for example, with medications, corsets,physical therapy, etc.).

Approximately half of the patients who receivedthe X STOP device in this two-year research studyexperienced a degree of pain relief and ability toincrease their activity levels that was sufficient tobe considered a successful outcome at two yearsafter the surgery. The clinical benefit beyond twoyears has not been measured.

The likelihood of needing an additional operationduring the study was low. During the study, 6%of patients did not have a satisfactory treatmentoutcome and decided to have a laminectomyoperation (removal of part of the vertebra in thespine), at which time the X STOP was removed.In addition, the implant dislodged (moved outof proper position) in one patient after a fall,and the implant was later removed. A secondoperation was also required in three other XSTOP patients for the following conditions:drainage of a collection of blood, drainageof fluid around the wound, and removal ofdama ged tissue with secondary closure of thewound (allowing the wound to close on its own).

Please talk with your physician for more detailsabout the clinical study and its results.

23

Summary

This brochure has been designed to help youunderstand X STOP surgery for spinal stenosisand to give you the information you need to bean active participant in your own care.

We hope that you take the time to discussalternative treatments with your doctor and thatyou learn as much as you can about your ownparticular medical situation.

We also want to make sure that you understandall of the risks of surgery and the potentialcomplications that can follow.

It's important that you understand exactly whatthe procedure entails - including the risks,benefits and alternative treatments - before youdecide to proceed. Always remember that yourfinal decision to go ahead is up to you.

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Notes:

You may wish to record important informationregarding your X STOP Implant(s). Please askyour surgeon for this information.

X STOP LOT #

X STOP LOT #

25

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Index

AAnesthesia 1,17,19,21,23Analgesic 1, 11BBone spur 3, 7CCAT /CT Scan 1, 10Complication 21,23,24Conservative therapy I11DDegenerative 1 ,2,6Disc 2,4,5,6,7,12,14EExtension 1 ,1 6FFacet 1,5,12,13Facetectomy 1,13Flexion 1, 16, 20Foramen 1,3,12,13Foramninotomy 1, 13Fusion 1, 12IInterspinous Ligament 2,19Interspinous Process Decompression /IPD2,14,15, 16,17,20,21,22,23,24, (All Covers)Intervertebral Disc See "Disc"LLamina 2,3,12Laminectomy 2,12,13,15,23Laminotomy 2,12,13Ligament(s) 2,3,5,6,7,12,14,15,18,19,23Lumbar 2,3,8,10,16,17,20, (All Covers)Lumbar S p al Stenosis / S pinc1 Stenosis / LSS2,5,6,8,10,I1, 12,16,17,20,24 (All Covers)MMRI / Magnetic Resonance Imaging 2,10,22M'elogram 2, 10

Nerve 1,2,3,4,5,6,7,10,12,13,14A, 15,16,20,23Nerve root 2,3,5,6,7,10,1 2,13,14,160Osteophyte 3,7,1 2PPedicle 2,3SSpinal canal 2,3 ,4,5,6,,1 0, 12,1 3,1 5Spinal Cord 1,2,3,5,10,12,15

26

6S;

Spinal stenosis See Lumbar Spinal StenosisSpinous Process 2,3,6,7,1 4,1 8,21Spondylolisthesis 3, 7Stenosis See Lumbar Spinal StenosisSupraspinous Ligament 3,6,1 5,1 8Vvertebrae 1,2,34,6,7101 2xX STOP 3,14,1 5,1 6,1 7,1 8,1 9,20,21,22,23,24,(Front + Bock Covers)X-ray 1,2,3,10,1 9

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66

Facts About Lumbar Spinal Stenosis

This brochure will provide you with informationregarding a new treatment for lumbar spinalstenosis called X STOP IPD (Interspinous ProcessDecompression).

You may be suffering from lumbar spinal stenosis if:• you have difficulty walking distances* you experience pain while standing* your pain is relieved when you sit down or

bend forward* your pain is mostly in your buttocks and thighs

The X STOP offers several benefits compared totraditional surgery for lumbar spinal stenosis,including:* the option of local anesthesia* usually no bone or soft tissue removal* has the potential for an outpatient procedure* fully reversible procedure that does not

limit any future non-surgical and surgicaltreatment options

Your doctor will answer any questions you haveregarding lumbar spinal stenosis and the X STOPas a treatment for you.

ST. FRANCIS MEDICAL TECHNOLOGIES, INC* SFMT USA

960 Atlantic Avenue, Suite 102Alameda, California 94501 USA+1.510.337.2600Fax +1.337.2698info@sfmt.com

* SFMT EUROPE B.V.Hoofdstaat 2483972 LK Dricbergen, The NetherlandsTel +31.34.352.3890

Fax +31.34.352.3891europe@sfmt.cornwww.sf[m[.comn

( { 0344 CoC Utrecht: 30180148* C 2%X5 St Fiands Medical Tetnlois Iac

500372.Rev.A Printed in USA

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