Durepair® Dura Regeneration Matrix
Instructio ns for Use
Cautio n: U. S. federa l law restr icts
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Package Contents
Use by
Caution
Reference Number
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Lot Number
Manufacturer
Storage temperatures
Do Not Reu se
this dev ice to sale by o r on the order
of a physician.
Sterilization: Ethylene-Oxide Gas
Consult I nstruc tions for U se.
Do Not Res terilize
Sterilize
Durepair® is a registered trademark of TEI Biosciences Inc.
Durepair® Dura Regeneration Matrix
Description
Durepa ir® Dura Reg eneration Ma trix is a collag en implant for t he repair of de fects in th e dura mater. Dure pair is suppli ed sterile, in a
double -peel pack age, and is inten ded for single (one-time) use-only. Du repair is avail able in a varie ty of sizes inte nded to be cut by
the surg eon to the desir ed shape.
Indications
Durepair is indicated as a dura substitute for the repair of the dura mater.
Safety
Durepa ir is manufac tured fro m bovine skin, on e of the pures t sources of col lagen that is com mercially ava ilable. The sou rce material is
solely d erived from c attle obt ained in compl iance with Unit ed States and Eu ropean regul atory requ irements.
Instructions for Use
• Inspec t packagin g and reject p roduct if pr eviously dam aged or opene d.
• If Temperat ure Indicato r Dot is presen t, DO NOT USE if Dot is b lack.
• Peel open t he outer pack age and asept ically delive r the inner, ster ile package to t he sterile e ld.
• Rinse su rgical glove s, if necessa ry, to remove any glo ve powder prio r to touching pr oduct.
• Remove pr oduct fro m package usin g sterile, atr aumatic forc eps or a gloved han d.
• Cut dry D urepair to the s ize and shape ne eded to cover the d ura defec t.
• Soak Dur epair in room te mperature s terile 0.9% sa line until hydr ated (typic ally less than on e minute). Hydrat ion is indicat ed
by a color ch ange from whi te (dry) to grey (wet). To fac ilitate wet ting, press ure can be appl ied with glove d ngers acr oss
surf ace of the device u ntil Durepa ir has a unifor m grey, wet appear ance.
• Keep Dure pair immers ed in sterile s aline until r eady for use.
• Durepa ir may be implant ed with eithe r side against t he brain to cover t he defect , and can be sutu red in place usin g 2 to 3
millime ter bites in the g raft and hos t tissue.
• Alterna tively, Durepa ir can be used a s an onlay graf t by trimming Du repair to a size p ermittin g a minimum of 1 cm ove rlap
with the r emaining dur a. Stay sutures m ay be used if des ired.
• For bes t results, th e graft shou ld be applied an d xed in place ca refully.
• Discar d any unused pie ces of Durepa ir.
Storage
Store at ro om temperatu re (2°-30° C; 35°-86° F ). Keep away from he at sources.
How Supplied
Durepa ir is supplied s terile, in a dou ble-peel p ackage, and is in tended for single-use (one-time) only. Durepair is ava ilable in
multip le sizes. So lon g as the packag e has not been dama ged or opene d, the contents a re guarantee d sterile and n onpyrogeni c. If
Temperatu re Indicator D ot is present , DO NOT USE if Dot is bl ack. Packag es for each of th e components s hould be inta ct upon rece ipt.
The encl osed produc t is designe d for single pat ient use only. Do no t re-use, re -process, o r re-steri lize this produ ct. Re-us e,
re-pr ocessing or re -sterili zation may comp romise the s tructura l integrit y of the device an d/or create a ris k of contaminat ion of
the devi ce, which could r esult in patie nt injury, illn ess, or death. D o not use if pack age has been pr eviously ope ned or damaged .
Medtro nic Neurosur gery is not re sponsible f or the perfo rmance of any pr oduct that ha s been reste rilized.
Patient Education
It is the phy sician’s respo nsibility to e ducate the pa tients and/or t heir repres entative(s) reg arding surgi cal procedu res involvin g
dura rep air. This should in clude a desc ription of ass ociated war nings, prec autions, com plications , and an explana tion of potent ial
alternative products and treatments.
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Contraindications
• Durepair is not designed, sold, or intended for use except as indicated.
• Durepa ir should not be u sed for patie nts with a kno wn history o f hypersens itivity to c ollagen prod ucts.
• Durepair should be used with caution in regions where an infection exists.
Warnings and Precautions
PHYSICIAN NOTE: The physic ian must convey t he indicati ons, contrai ndication s, warnings and p recautio ns given in this d ocument
to the patient.
• Do not res terilize as th is may damage Dur epair.
• Do not use i f the produc t package is da maged or opene d.
• Do not exp ose to any chemi cals or subst ances other t han room tempe rature ster ile 0.9% saline.
• Durepa ir is for single -patient us e only and is to be im planted surg ically.
• Rinse surgical gloves to remove glove powder prior to touching Durepair.
• Do not use p roduct if pa st the date of ex piration in dicated on th e package labe l.
• Do not use i f product ap pears to shri nk signican tly when hydra ted.
• Animal s tudy result s suggest tha t the foreign b ody respons e associate d with the use of s ealants and he mostatic ag ents in
conjunc tion with Du repair may be mo re pronounce d than use of Dur epair alone. T his response m ay increase th e incident rat es
of known r isks of dura su bstitute s, particu larly in high pr essure grad ient applica tions. If inte nding to use anc illary prod ucts
with Dur epair, ensure th e product s are applied in a ccordance wit h their instr uctions f or use.
Complications
General risks may include infections, CSF leaks, adhesions, hematomas, rejection/foreign body reacti on, inammatory reactions, and
calci cation. The p atient shoul d be made aware of t hese risks a nd others ass ociated wit h neurosurge ry, general su rgery, and the us e
of anesthesia.
Returned Goods Policy
Produc ts must be re turned in uno pened pack ages, with man ufactur er’s seals intac t, to be accept ed for replace ment or credi t, unless
retur ned due to a compla int of produc t defect o r mislabeling . Determinat ion of a produc t defect o r mislabeling w ill be made by
Medtro nic Neurosur gery, which de terminatio n will be nal. Pr oducts wi ll not be accepte d for replacem ent or credit i f they have been
in posse ssion of the cu stomer for mo re than 90 days.
Warra nty
A. Standard Limited Warranty. Medtronic Neurosurgery warrants to the original end user purchaser (“Purchaser”) that
the encl osed single us e or reusable p roduct (“Pr oduct” ) purchased b y Purchaser, at th e time of delive ry to Purchas er, shall be
substantially free from defect s in material and workmanship. Medtronic Neurosurger y makes no warranty (express, implied or
statu tory) for Pro ducts that a re modied (exce pt as expres sly contempla ted herein) or sub jected to unu sual physica l stress, mis use,
improp er operatio n, neglect, i mproper tes ting, use in com bination wi th other produ cts or comp onents othe r than those fo r which the
Produc ts were desi gned, or use in any m anner or medic al procedu re for which th e Products a re not indicat ed.
B. Re medy. Pur chaser’s excl usive remedy a nd Medtroni c Neurosurg ery’s sole liab ility for br each of the for egoing warr anty shall be,
at Medtr onic Neurosu rgery’s sol e option and ele ction, to rep lace the Produ ct or credi t Purchaser fo r the net amoun t actually pa id for
any such Pr oduct; prov ided that (i) Me dtronic Neur osurgery i s notied in wr iting withi n ninety (90) day s after Purch aser’s receip t of
the Prod uct that such P roduct fai led to confor m, including a d etailed exp lanation in En glish of any alleg ed nonconfo rmity; (ii) su ch
Produc t is returne d to Medtroni c Neurosurge ry within ni nety (90) days af ter Purchas er’s receipt of t he Product F.O.B. 125 Cre mona
Drive, Go leta, Calif ornia 93117, U.S.A . or as otherw ise designat ed by Medtroni c Neurosurg ery; and (iii) Me dtronic Neu rosurger y is
reason ably satis ed that the clai med nonconf ormities ac tually exis t. Except as e xpressly pr ovided in this p aragraph, Pu rchaser shal l
not have the right to return Product s to Medtronic Neurosurger y without Medtronic Neurosurgery’s prior written consent.
C. Excl usion of Oth er Warrantie s. EXCEPT FOR THE LI MITED WARRANTY PRO VIDED IN (A) ABOVE, MEDTR ONIC
NEUROSURGER Y GRANTS NO OTHER WARR ANTIES OR CONDITIO NS, EXPRESS OR IMPLIE D AND MANUFACTURER SPEC IFICALLY
DISCLAIMS THE IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILIT Y AND FITNESS FOR A PARTICUL AR PURPOSE.
MEDTRONIC NEUROSURGERY NEITHER ASSUMES NOR AUTHORIZES ANY OTHER PERSON TO ASSUME ANY OTHER LIABILITIES
ARISING OUT OF O R IN CONNECTION WITH TH E SALE OR USE OF ANY PRODUC T.
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