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B.r1tn, t,ersiany - L tiot Radeta~tcher, seized by savere ciust psittt ind shorc of braath. aEmoct dind $toat catssesctve heaet failare We last yeir. "(bday, the S!-ytu-otd latttttage teuher aut visit a favotite tt•atau• rant usd Walh with his family ia tEte to+mmer stiaalsine thtutlra to i mlrade of U.S. autiiciae. Ridezathar wtatz i pottsbie devics that he!ps his hcatt pump blood, s mtitvci of asin(t+turias- tion made by a Califarnit divi- siao of 6sxtez Hesitts Care Cotp. ~ Uafott'Aa:;cely, tbi: t~iraeka of Nnsticaa sacdiciate zi atl but ttaavy,il4le irt tbe Uaited States. IR LutZ Rademac,her, a Gerrnan heart patient, carries a device that keeps his heart pumping.'1'hough developed in California, the device is virtually unavailable in this country, ..............................~~...................~............ ` s•' ,TaEtt E~tTbrar~ IiVy~S h tt Dr1.~iuo&J..CE~t$f ~ e ~ ~'~ ' ii f~c~ ~ Cor~ Mike a Ec~nomit ; r Radern.cher's ease is onRy one t:xample of a bro.d teehaoioyy sAiit tlut altourt; Eutopeaa add 7spr+nesa'puienks aeces; to siste~af-the•srt we awtutu or years ahoad of Attteriestnsr. It's ai:o psrt of a quiet tipputg of the bs{katsx in the advsaae- meat of Rtedieiae beyond U.S: bordea, oaa that bae troublirtg irapliaatioAf for the future of Apatieat 67te Ridemaciter at tha Mjmeapoga Heart iastiwte will spead moss of bis time In a hee• piut bed, tethared:o sfl olde: deviee so bulky that it hss to be mo+rod oa a art, Whik R:<de• rnuoer ca,r, conteesplste toirta • homx. ew,a rrorkiaS, most of his , ""telp#iYi WntEla~ the itiSh•tecb health care irtdtss• try in tlse United Statet tad Mistnecott- and perhap. for the medlcai trestatent of Araer• iestu. T}te UA;ted States retTiaittt a world Ieader in medlcai ideas aad lcnnow-how, but on atatty fraat>f. U.S. medititse is losing the edge in ittrioYttion and the spplirrtion of mad'ent s:iettee. A 5tar Tn'buae irwestigatiort of the suta of aaadiai teehnciojy in Ettiope, Asia and North Amaaa revea~i th~t: a ta marty+ h W th Gatds- txoat ardiso,tugery te urolosical iGtpt-ints to CariCOr illtetvesiwA -- US. ptuients no tbnpr can be aswrui they are receivutg iuu• of•tbe•ut care. Sme prarnirtent U.3, physiartns ara dSreeut6 puieAt; oyersaas.  Gff+etammttts of neirly every uydusuitiized nation - rnost with eentrnUy plutned heskh sys. tem ridiatle,d ru stodgy and bu• ratuaatie by some Aautzemats - do a better+job than the Utsited Sutss of caeocu.airt medical iaatmtiM Nthou puleat: ttt these costncries msy e uJtsa= 'titka AMeticuts don't t" there's tittie oYiderMe that they are harmted. '!hs 1es in gettiag iaaoritioa to market in the United StAtu thretitetts the wntinued ruality of what hat boen the fastestKrflwir,g setaor of Minrtewta's ®tonotay.

• "Through innovation we can simultaneously .increase quality and reduce costs. I f we want to speed innova- tion, then we should think what we could do to stream- line the regulatory process - not to get sloppy about safety but to get rid of any unnecessary steps." - E.Use.a.th Temet9, asleelste ptohuaat Nawud ftaUe" 8ehW

When the best care is BRAIN: New treatmenae for pA~t or movement disorders devel~ able in EWap®, but not 9n the Unitsd Statas. For his anfy shot at stay to Japan for a cancer treatment he coctld not get tronl U.S. colte t~8g over there n g afiva a wyam ng doctor~e4vlr is. EYES: Bitocai interocular iense€, developed by a C,aGlornia dootar, wili first be warn by Etirapean: HEARTa A hast of prosthetic heart valveo. dsiibrlflators - and leads to connect them to t?19ir power packs --ive a.'aiSabte only outside U.S. t:order5m ftugh many were itwonteo in Minnesota. ARTERiES: A Minnesotx 'malter ot a oevice to clear blocked arterle expacts to apend $2 rni9bn ta $4 million to win FDA approval - twice wtt the research will oot3t in EtJrope. The 400,000 angiopfasty pasients treated each year In the tlnited States will have m wait. SPINE: Americans sutfering from severe chronic pain have to Ay to AuW73ii?Or s U.B.rdesigned device tor aen0inp e4eCtrfaal impu(ses to the spinal eord to ®etse discomfort I E(1dNEY'.Sr: A Mfrtneapolis cornp y that makes rtlters for kidney dla ystr rnacftIne9 tnd relatdd pr*ducts latd ott 40 people last faN, but soon V De hiring - in Europe: FDA delays in pr~oduct approvals prompted tit® company to decide to open a ptwt in Hbiland or aetgium later this yau, PROSTATE: A Minnesola camparty designed a coll to hold open tt% urmary tract for patients With bartiigrl! prastate swelpng. Mors than'1,5 have been aold around the wartd, but oF,!iy about t0 (n the United 9tales wttere the RCtA lnalsts on lon.g, eVensiy® chnical trlaly of tha product, ev thauQh k'9 UlU0 more tMan a rettnetr+ent!of eztrtinq teahnology. ~ SOI+fE,ti0 Saveral coururis: are ahead ot the United States in provic bone•msrrow transplants In the early, rrmoet.treatabie stages ot {euicemia, aaording to a reeent 41.5. 3enorml Aecountin9 Ott3co study. 11`aOp. Artificial hemoglobin, designed for savirtg the ilves of trau plWents tr.ated by ®rntxulance crewe, wlll hR the streeu first in Europe. cl.S. vompany rnxhing ths product was truetrated by FUA inaistence on eijrled Conaaritlarrne ftom paiients- many of whom are unoonsoious wMn sn ambutanc® Arrives. O

• Doctor went to Japan for treat ent - he couldn't receive ~n America ! r~ M~6Rei Werr~er, a Ye~9oti1 ~Ni~COb' 1A ~k Sprmgs, Wyo., dixqwGred ht ~ad f+ tarm b~~m olbtva D esr bst Oecober. H~e belierrs he's vtvs tOdray chtnhs to a wonder of asodgm meeitt:tae~ But th! wolftler WJ.L tA Japsn, Tsot in the L?nited States. W.rner flew to'lbkyo last faiW and =pent 160,OG0 for aa UpN7tMataJ tretsLmenr that doet tsot have restlasry sppseYai in the Uaited Ststas "Moat of the pstiaatt f who have tba Mse Csttaerj ue aooixd "' WAerner ssid. "Thay all dk." ~ Althou6h werbei atsy not know !er some time wbatber or nos he is Nred, he had to trave16,000 miks to mke wbat may be bis oeiy c6anca to best his txaCer.ln an uacoRveetiotu¢i form of radistion tbsttpy,7apaeese t~usSee~ns expakd bis tumor to thermal strntroas Pracjstred by a nucloor teutor. "Why did F luva to So to Japan? WEiyy waldn't I have the treuaseat be:c9" Werner aslcsd. "Thia is sraty," U.S, nuclear rea=rs sirni• isr to the ont Wotae=vWud in iapraA muid offer ths stnu troat- rnent, be t3id, but tha fadaral gcw ernmetu is neither pt~ far nor ssqctioainS'stub reaearxh. Some t;orciga treatmetus%uy oEter' fasaa hope to patioats. TAetar'a no ` t arideaoe sltu "t~wt p~ taartara admlatstt;red br Mt;zuenn doctars eaue eaneer ef potions fsam Helcinki grow kair on bald statps, Bttt tha ease at Wernar's oaaeer shawr that tseacnaents wa remaalcable suCcess alse tra a long time coniing tQ USZ r,hosea. W=er aaid OhE'Jrpanase have truted t20 patieets witis brain tumors like bis - e SUgsatoma mulziftum ~ and raeengly report- ed ttut 52 peresnt of the puienti sutyived five yeaz3 and 19 percent 1Ned 16 yeara after,treatrAeat. After treatMent with =trit:atf on4 radiotherapy or cbematherspy, 90 pozeeat of patiants with the dis- ease diewithia 12 tnoaths of d't4j- Wstr aod 99 pertent die wlthin five yeaa. "I don't kaaw who (FD.4 offieiils) nre prouetiny" Werner ae.id. "Sarnet;rnes you woeder." --Mika Mvyeri tipedal to tht Siar Tibwne by 0. Thomas ti,.n 0

Htgh'tOCrt. "rlullbuu „V.., r.~5_ .. lnaeasirt~ uumbors ot Mir+nsiuta masioal eomp"us are creaiing jobot overaaas. Uadar more favorable tireumaartces, many of thoae wouisl have been genernted in the stits, rciing to z Star 7ribune a¢rveY of Mtrtne• whign-teeh tnec4iczi devicc rrtanufaaurer5. Md vanture cap"i is diftu.vlt to find in the United Sctites for new rnedieal devieec, whAe It Is abwtdartt in Europe and Japan. Then ptabkrut sre t~e resu3t of a somplex btasd of inbre~ient:r Ttte Food and Drug AiirttU7istrarlon (FDA) is bwietj under i Stoun, tsin of S,OOO:pp3tcatiorts, U.S. U;bil)ty hwsttits add prsssures to regtrlators, rtaa up the ctues oP produet devetoprnartt and tYuoaten to dry~up the supplies of raw materiAls uted in making taediesl devices. Meanwhite, tightGsted Medlcare rnd private insurartce oftieiRis ofcen rsRtse to pay ror tet'siag new tecltnolagy. 0 The FCrA: too siow tn ttu IdMted States, 400,000 man every ytNr must take dnsga or go Nndt;r a eur• gs"'s knife to ueat betUgn prostats awNling. But in t:urops, men with the AAnu. problem luvs a third, aafer and paln- tesia alternative-- e ttny coll, de+st ned in MMnesota, Is tmplanted In their t~pry tltCte te kesp tha pgSEagtlWay Open par• rttensntty. Siz morsfh= after ths produex waa lntrntluosd in Eurqpe, It's etilt no1 svattabt. In ttts Urtit.it Ststt:;. ItjSuet, the Mintu:ota cuutpsrsy that ntakes ~ the coil, has sctltl abnut.1,500 of the uro(ogiea! ditviesa abroatl4 ehietly ist Europe. Only 10 tiave bcee implanted in U.S. patients on a trial basis. India, a Third•World cottntr7 that scenss iA unftkCbl pliiCd W firtd taidtp6•CdBC teChnol• qgW, hat more than 50 patiena wearipg tha iaitent eoii. Sueb stories tta+rs becorae common, AHouse Oversi6fn ynd Invcstigatiorrs sub- tomtaittee investig:;tion last Aug-ttst showad IsAi,i+ FDA delays eran, esuss itte United States t0 fall farther tnd farther behind in the ivail- at+ility of inedicel cechnolo;y. Tlltt subeotamittce cited reports that 49 U.S.- ra++de taedicri deviees- many potEtturily tife. savta=-were tted up in FDA reviewr whilt approvals were gronted by resulators in Ltsope snst Jipan. The repon said sakx and jt>~is wyrt 1ott, t{nd sntall cuntpanics were c1ri. wst otu of busirusa ay the delays. Worso, pafieAti atsffered. "Doctors and patients in tho U.S. face the daunting prvspcct at eitbor havini to travel to a fore~'tt land to havc :{eetst to the lateat nted• icai taehnology; the report:airJ,'br having to gcNpt a teu effective and/or a higher risk treatrttent for ttteir ilinea in tho uniccti 5ttttea," . Are these eongression.l reports wcaraples of Capito! >:Iill hypertwlel Not to researciten ond innovatan at academic aenters ranging from the Universit/ of Min. nesoca and Rectssstcr's Mayo Clirue to the Biylor College of Medieine and 5tattford Uni- vsrdty, Mfanesots surgcry . -~ Gerraany anti Jspan - t{re pustung research and:eatiu it ic the Iuture. Tbey rcallzc it'a irnpohant while we rre piuliing bselc" Hvory day the FDA delays alearfng a device for matketing, aonte Mtericans mpr =et aick or die for want of a new treatrnent for their itlctes+as, "We arm n9akirg irnproveraencs in the tirnt: needed for ap rovala,.aad we have set priori• ties far brea>rough and tife•saving toehnol- ozy;' ssid Dr. 8ruca 8urlington, djrattor of the FDA'S Cencet For Devices and Kadi4logical Health. Burtington's efforts s;re appl:uded, but tas timas remaitt atg4if'lant even two years aftttr he was appointed. The;reforc, FDA approvt,is remain, in many caus, exaettna ana time consvnsittE. From the astnry's panpacsivee publie and poiiticat pres• sura w,ll not toteryte wideiy perceived ga8'eg such as the approvat of silicon tueugt intptsnts, suspecxcd of aausing injury. Some medital researchers think FDA rstutior ho: a price. "it's not i matter of our los'tag our adge. We have aiready lost it," said Dr. Arthur Beall Jr., x profeuor at the iStylor College uf Mcdicine X Nagging legal fears A.fteaR sttaok vktftn tn Psrts, Copanhagen, Sydney oe Capotawn Ic likely to be rosuteluted utin a "oardiac pump" developed by Dr,~eittt Lurie, of the UnI• wrsi;ty of Minnsaotts. Arttbuianaes In uots olttas ara required to t:arry the portltbie tprbl= a i In field u~wAmerlans have noal aocass to this teehnelogy. . 149 motub, the F'DA probtbited evon testans the device bacsuie, among other ttyngt;, tlte agency tonnd thu rsot all patients had signad eontent forms. "T'bsCs a dlffieult task wh4a the patianci ara uncanstdous," Lurie said. . The FDA also asaerte:j the study 1119414904, '•we're a year and a half behind the rest of the worid, thanks w the FDA," Lurie srtid. We don't gef the .,. equipment ive need to save livas " tt't a paradcx. Free.mtrkoteets in the Uaited 9tattos view ehe heakh syscerno of cather aatians as "sodolired raecKeiae" stified by eentraliud bttretttattitt nuthorities. But those countries hs+v steeker reg+llttory buteaueYacies cbat often proviule: esequn nimulus to innovbtion and iifo-savirtj ttare, No one suggeas that the FDA quit rigorous ccst- 1ng and demand proof of eg'icary for new proce- dusec ic'€ jtut that, in the view of y growing nutnber of inetilcal rosearcl3crs, eurrent dtsmands go beyond remsoa. 1. Donald Hill, a eardievasauiar surgeun with the Califnrniz< Pacifie Mett'seai Cetner ut 5an J!+ratufsro, sairl he wottid zeronitnond that loved ones in rxeci of artmia lteart prt+crdures travel to ]:urope to rettive statowf-the-an csre. "I'd go to another wuntry. Ttxere's no ques- tiatt," he said. guIrtj patieras' wea ana aa.-..- ...-. _. patiants ipt ttto~tuse medical estre in ttie w•urid. Regulatars areti't the only barrier to new prod. ucts. Clas.:iction inwsulu asz: sutothcr hurdie. i The alarm wtts aoundcd itt VA+ahiagmn last ntonth whec d re, nru~ufacturcrr: and t~rr samat advvcat s~garhered before the Setttte GeMernntantal airs sitbCUmmiuce on tegu' lation. -ncy daar)bet! an impendirig crisis growina out oi ttuppliers' ralurnnc~e to pruvide materials for manuFsttuting. A 65 pim of plastic uscc4 in a device tbat fails,coukd leuve the supplier opea to millions uf rlcliars; in penatties Dui'ont Co, tlir exuupfe, wld the hearin; that tr#wuac of a fbar of iawsuits, it po longer ts eco- notctiaii,y w}twhile for thc cartrpany tu supply tdloti used in paeetnakera, which 14t1,WQ patienis a ya rescive to control en irregutar helrtbeat °We tace a reltl und imminent tlangur that hi h. quality, life•wving artd lifa.dnhanung me>Vica~ deviccs will become un•rvail4Wc becnusa criticsl m+tterials ancf c~+mponants ste unavaiiablc. Fur prttients, tite CUnYequencas cun be trngie." sai~ Paul Citron. # viee presidcnt ct f Fridlu7•bu¢d Mcdtronic Ir~lc., which maltcs heart trcatmcnc deviers Manutsctur always complain aEwut tiabiliry, but in this oa C the coatplttlnts are partituiariy worruome: ttltout a cltattge in the rulcs, mnrr ufieturing o wldely used do+iee3 in the United Stueaeould ccuttailed_ i!ltartor cattEr, president of Meatktz Metl icals lnc.. w ich tnakes vascutar Srafts. told the eocnmittee that when ha primary U.S. suppker of synthetle rn pulled out bts;attsc offafar at lawsuitz, $he~scarcitcti tita world fur :Flternrtive She discovered 15 suppllers were aucresicd in providinE ter.al tOr worlclwide distributioa- acetpt tn th Unised Stltes. Even i( she fouad supplier wu ing to allow the product for sale in this eount site saict, "Titr tttne tuquircd tv w goKrruncn approvai for the use of new mater t.ta eut m• a the ptoaeut prottibitivc." 9 u.& job's threatened A Mrrsaathueeus 11rtn oattod Illtmtmtt 'fiaht:nl y two years aga upplied for FI approv#4 r ne~+r equiprnant to perform laser stu ery on the eorr»e to•Improve prtient'g ;ion and, in many cases, pre rertt the tleed.tor corrtsat impianta. As many as 20,0001J.fi. patients eoutd bar trtant the 0avlee. T#te FDA t:alei It took t, yeu$ for Summit to satisfy the oge:retr that r3ll th+e rsgutatora' questtons had'b u4woreql. The finel go•ehstd may not oorris unpi later this yasr: In the rne ntime, Summit ~pt;ncd u(uctor, Nlgh•too~ continued on pege 14A 2046936772

. NeW devices avail'able in Europe, but not here 5 t Infant patient Ventricular fajlure rneans likely death for a child or, at best, life sustained by a heart- lung machine. But Judith Langnas, above Ath her mother, Birgit, avoided that fate with a newfy developed heart•assist pump just for children.

ne-yeat.aldJuditii Lanp3s wm Aeas deatb oa an. oPetz{ona tibk 4n Barito fa April. Buc tur liits w~ epared ology u yvutlE s stu ia. sditb is aliva todsy beedttae ef 'suropean WiUingnesc td fznMCa epd ry tesdirt4•edg6 deviees -atppiiea• iaes of saceaee boldet chsa thoro iA he United States. me aite cf her surSa.ty, birSta Ha~ pits1, : part of iiumboidt Ur+iverfity, has Xea s t7iaJ aeAter for hoart•utist devk" in rexnt ye.t;rs and its reputs- tian b putidittg fast. Cns daY kst Aptil, wIIetl Judith's hoert quit best• Ch3ti*ta 6eaune perhspa the wottd'3 Grst aenter to apply.weh a devia to a dnild. - 'Ihe uory begias in March 1993, dys i.ttar Jttditly wat bvrrt, wbee her doctor reoognized a prvbletn. 1ba infant had ewolian ligenips uldseetsesl waaSc. WSthin weeks, tbe speeislate at t:hsrite grcvided a 9sm diignasis: tetrstogy of Fsilot,:{ putkxflsr3y rinister hesrt defeet. Tbe zytfdroase inetudes a tnal- fotmad haart valve and a holc in the wetsioularWai1. Thms def,ectw pta• vaat the heut from purapit~g a#foc- ~revelr, cautin; peor cireulatton, sscaess and early death. taA ti2, doctors at Chasito told Judith's atother, Bitgit, that it was ticu !ar sdrSsry. It rrppeum,to be $oittj smoot[tl,y at first. ?hett one of the curgeoa essped..ludith's heart ipparentty gave out fzoas the strast• at t3u praertJtars. Alsht veatrieular feilure." satid Dt. Hotst t.eube. YvatrieuJar fiiture means iikety death fot a ehild. For s;duits, there are deviaes that can be applied sua dericW !ot otsttaren aaX"k-.... ..- che ututed Statea, the only option atraiiabte wouid ba to put ~ ehiid e•n a lairt-htaa ttuettine, wEuds Cin lead to •tajuttee. But the Cbsrfce Wgeotu bad aa xdranuge unknown in the utltkd Sntcs: a tiewty deveioped hatrt- aasist pamp dos+gead bX a Gsruttn CCC1p~ttty fta' impieutatton in chi!• drea.~ e ptototype was ' da Wnad ia eonjunctan witb the Univarsity of Aaehen. Aod oDe of theae de•ices was teAt to Csatits shonly,befare Judith't Opctsuott. 'ltlithoWt this devke, Judith wroulsd hnve died," ssid L,nube. "T!•3~ daviee is oe~e we have'warYted fot sotne time. We have iRtpitats that we an W ften an edule ventriele faits. Btlt we hsve W aot,bias Fer kidc." Judith'a mother clutehes ber diugts, ter as she ekaarSbes her shock on lsarairls that the ia.itis7apertuoa had Aone poorly. But 24 bouri laier, Judith s beart had t•eeovered ustd was able to beat on its own. • In the,Unlted State.0Jac eeeoar wilb swe spp~uu pdra teuthi of rsgt+Ea. , "They did a terrific th1nS.° sziid Dr. Joifrey Sei1, Catdiae surjeort:;t CbR• dren'c National Medical Center in ftbJtt;ton. "Wiii I get to do it hero? No. 7u reuon: Ie this coun- ay, sueh advaaces requi:e hu e frottt-end outlay of resources~w get iruls approved by the FD1t,) end wE no longer have theua resources. ._. ln ternu of devices, thtry have greater scaest to a variety of tech• aoiW than we have here. And, itst'.t: iaa it. malpracsice tbore iso's s"h a probiem." -Tbrn' Hamburger U.S. mediou d9v+eas; p,Xaiisbie ov.r"as in 1 o93 • dozrn U.S. mediesi exn+panles (ast for s;8!® tllonths or years befar8 vvir,nN , Lagging behind lifrsaving or liftanhwdng rttedle~al d ohrseas ior yon trefore Mnerkans desrance, salow iis e3n'tpts o1 +9 qdvkes, shawrir+g how long etuh ws an tt* rar4cet arer•. $0" b®tor® release In iJv UnRrd Btdts: -4 R~ aim Ike 10 : M Is a QR18y 1R ~ l,t" SuC aYaiiabYily -~-than =lx mernths of sa,ae :~ L menttts to a y¢r:r iorS m ~4raetHe~ii~,~.- ~.:.,u. svioes often we svalleble et to use thQm. A Su+vey of tOtcnd they had devioes ~ federal i 6 aim at ~ sit ~ as ~~ ~~ ~' ®a as •' ~ ~

>~tii/i lrhoUp Vy Mulirt LarW 9 Heart patlent Donald-Lundgren, above, had a defibriffa- :or impfanted in his body to regutate his neartbeat, The device was far {ess sophis- tiCated than those available to Europeans ~uch as Charles Geidhaif, below toacher, feft his cairt Quttcr whiJe be was mowiog his iawn lass year.lbt orm point, he cowued 169 bests per mitaute. 2n NevemBer 1993, a sar6oon implantod ia 4efdbolf a stste-of• the-an det~brillsser - r deviw tb.at regtsl:tes the heirtbeat throttgtt f eleetrre signais, Now, Geldholf can Siw flrewot7d for his iilofAe outudo of 8rAwis w;thout i lasing his bresth snd ean take a wcation by the sea without worryiAg thyt he s aa hour's dsivo trom his etrditawsistf t3eidhalt Can ekank FYidieybucd MedSronie for his freedom, (7onild LundQ,reA Oj St. Croix, ~ Mian., wasn't so lucky. He i>S bUW ~ rnilos nlo:Cr to the home of ttte trr.h- aotogr that belped Creldbokf, but the sa<ms cue is aot svtilawe to him. The U,S. Food artd Drag Admiais• I trttion (FDA) routirselY does rsat approve;dvsncad detlbnllatOr devioes IAIr eea+mereitl uss tstttli mantls or yeus Bitor thoy sre avoil• (.+a~`.... ..,. .~.. ~ _ . ~ prene to coatpliations than con• ~ vetttionai open•heare surgery. Lundgrea said the sh4ek provid.d by his fiTSt dCGbriU+teu was so erud that be berama less afraid of a hes: attxck thsn of theaansation of tha da>1brWaror ltris3g,'Lha,>;hcclt of th devica wat so grut thu it mtud lcnock ttirn to the gottad. F3e raret tett h~ houso and tvok ud>aives e+ nisht to steep. "L{fo wisn't tife iny morc," Lund• grert taitG "E wsa ttetYOUS and cear, a11 tha tirt+e" LtuidgTCh's sufforing Ixctec( thtee yoara ln A ril 1993, he goi a ra,oY modorn deritlator (tbau.gls still ti0t as idvaneCd as those tiSOn Ivi ible in E+arqpe) and his liPe has ehahged dra.matlco.lly. Tbday, i.un gren hoS Ao lexr of trt+'o Uttg or gotng on ourie.gs with his wife. Ht spCet lsst Winter in Pht?enirc, "Mi g,et my new dtfibri!lztor, fife rasd eomplete turrtaround." he said Such lurnuoursdc area't hsppcai (ast enougb for many U,S. doctor 't1tey y+uu to be abts to usa rnedi dev,ces invented an}y a few msios trom where they practise rnedidr bnt widely avuLbte oa.lr thauun of 8t11os zway - in Eurepe, Asia eaep Gtuda. a<bia in Etuope. At last ea= 26 heart deGbrilLttorx and pecetaskers were ava(1.b)e in Furape,bafore the United States. li,ll were desigtted hsre. ! , Miny Ameriesn esrdiae surgaons are upset with the situation and I some are starting to seod pYtients Et,uope. If shay stiy in the United $tit0=, the do0lofl who t7Git tyCfi knaw their p><tients are gettinjtiee• oad•rate techrtologl+. ' We luivs a puicat a weC.h who in to be rsfetred for what I wouki eail inierior therapr," sols! 17t: Kath t.urie,•the Univessitx of Mituteseta cardiotogist wbo t:eued Luitdgren. I "DoaddLundgrett'c stoty iss jutt tbc tip of rhe inberE:" - Lundgren got his itrst defibrilluar ~ the w:r most U,. patients get theirs -in surgesy, wbore tbe chast is opetted ind awo wir+es are atttehad to th e h.ut uLd tetbercd to an im intible dafibrillatar. In today, most patients Teah~e ds~bsilla tors throug}s a s6ouider implant with vnly oaa lead snikod short darnneo to the heart. I It wasn't just the surgieal technique that w" ants'quated. Unti1 recanaly, Lutulgrcn and many othes Atses+- czrn received y primitive dat(brilla- tor devioe that uted eteetr'ie thocicS to jolt tpe hcan back into s nacmal I be:ting pattern. European esrd;oto• Jistt!>xve forfotlte years beea trsing u defibtilluor with i mere suiuk e/aotrio puing, to eue ebc bean ~ , , "Me rate of Cl=p m t.here dev is mind•bozglsng,' said L'tlivorut Minnsseta ard+oto&ct Stuart.ti ' More peepie um dymf tota s.t deA eardiLC dtltti thaA canCer 0 AI27S, sad tDe te:nnotoay is the that aould htw tbese peopis w ing and ealoy+ns thsir hfe in  r+ sonAble fasa,on - and they can use it," - Mprt Moytta

l • SW pnoto by 646m Uyian r Urology patient Edwin' Reed of St. Paul had painful prostate. surgery. But his counterpart in England had a pain-free procedure that, uses a device made in Minnesota, It will be months or maybe years before the device is available here. E awin R@ed, z 76-year- old recired receiwing olesh livirta in $t, F%ulL hYd surgery to treac an enlarged prostate. The n3ght Wtter sur8ery, the pain kept him ewajce t!d ttighc, and for w.eks urination was uneArafertable. Is pain the priaa of jrowing alcfer2 It doesa'c hrie co be. Dxtorz hare in alteanauva to proityte surSsry, buc mott psdectts ln the United Ststa eannot sue it If Fieed h3d beta &iash, Preneh or Dutch, he eould hsvo been ie and oyt of ksas doctar's e3Gcc in a staSlc mo:nirs. nttad with a c4evict, ailed a ccent, that redueze the pein-and exponse-af troat• itzs e arvOilea ptasrate, a pivblem that plaSM ddes nua Reed dldn't hivs to 091er. Ask John Hudaon. a ret'usd seounry ~and. T'he~76ye uu~wld 1A~riln t~13 wa3 gwen the treat~etu Ftted eould notget, "It wu beiutiNl," Hudeon n7d. "No piia; so prob. lenu, no n othsag." '37aa deviee, raadoby a Mitvseeosa coaspsn callad,I6%e,, 14 a ooiled tpring at is insesced uheougs the panu aad haWs opan tha uiintry paseagoway without ttttm, The itsStanc proct= is tavnc7s or yaars ayvsy bm sppro+reM by tno U,S. Food and DrvgAdministracion , (FDA), Sitiilar deviC05, ilso OwaitiAg FDA uppcvval, cart bc usEd to tcepopea ane~, blte duets and tb.eonts dem- t keeps the eGCpharu 3 OpeG so ey cia eat and driaJc without IVe craveaoyt feedictg]," said IcStem ident WAtsen 8ielko. "If '~c ~ ther t thst kind of eanaer, you'd e euing s~teak:ad pocacoes than tive an YV In you." d undcttirent a prowdure culled srarusutichra sectton, s surPrv lsese tbe proa<ats 1land is fiUstad to epen t utiiauy pasuge. CompliCUions ot tbs scuSery en includc bleed- tn~, inieaines stnd, in 5 poteeat to 10 perxnt af patienu, irapotet>rt. "It's one of the rssosc com• n surgicat proadurec in t$c untry," ssid At. Steven Moore, J2std'G urvlOglit. "A R1an.r thc sp of 5S :tsads about a 1~5 peteeAt . Ohsaee of eventtuttly neediq a ~t>iurctrtr+ scation." tiet ~ year, MoOie ~L po14tl6 iaa to seleec a haodful af puisnu or eiirti~l trial~ of the ~Stent alterrtaaye to ps~tue stage:y, ,Dr. Henry L4wi, the &itish dactor who implMted tfae deviea in 3ohn iHudson, said be camos undpntusc the cetuctznee of tAa FDAco op, pravc a drvice tAu's alreadr so wi*dely used in Euc+ape. bte alone has implanted ttwre than 40 of the lnSsent devimc ad as many e.s 3X urisyary stents saasle by eoASpeciton "WA're ves~+ happy with ehe sunt " Lowi etid. 'tr`s bbcompatibla and eacytv impltnt~' - 6Aike Mayera 20469367'76

¶'Jew technology quickly approved in Europa HI®h4sch oontinusd fram page 12A treYutd, hirad more than SO worlaers tnd ctttrt• ed praducdoa for s 8vropaan maricet ltappy to hqve tbe praduet. Ttse asate ctrstsg is being adopted by more arid moso Mianr.sota oompatUes, bsrnd from E:portlrla rrtediril deviees nOt yet t~5P0yed th's FDA and oaSer to re,coup the htgh eecc o. deYSiopina rtow produott. For theta, the quidfc• eit'tWutft lf tD open f pjtnt 0'ti+etSLSf, And, in ~ e ess~~ e~+aare6 sud development jobs Astt<r'fibtane survey of Mintlesots modiaal dsricatnako» found 24 compar.les will create i,Vo Jpbi ovlrisai in t13e Aelt JIM years if the *re~fd eentiuues. Thoussndc more may follow. eThe FDA hu taken some steps toward sped• ier approvals, but progess has been slow. Tb'e Summit laser deYiee is bei:ta used in 3S. o~atries. F~aroi~A sales, to~tiling some 300 w~ldwidr, saootinted tor vuttaalty all of ths etxnpsny's 00 tnl3lion in reYenuelsst,yesr, RA model in Gert»atty• In dKtnaRy, srtd otiter Europenn 001311, trUa, prlvat« panels vt exporta satuaionod ~tY i~+omvanta ~niw dtvie.slyTqbif 'epprwai tbtte eatt be as Ilefda as four m"e-a•hicttast of thtt dma reqWrtad ;to wtn PDA;pprovat to go to msrksa Most U.S. hsart surgeoos have stcver ssezt tbt ;dww tlsac Lutx RadamYeher tn Bet!'sn is weaz• tns to help lt}c heart•besit Mskta of the Novaeor device worn by Rzde•, rrtscher ssiid ths esss of entry into rntirlcets on tht other slds of the Attattic led therri to invsst moss and taoro of their eBorts in Europa• Rtdemsehrr is otte of 47 Huropesns with end• ctt~s hesct dicease w}to hsvE receiaed this tttto-okhe-an portxble hssct pun+p. Soon h{ftzidteds itt Eutrope will be we=tin j the device, ~ wbkh has been .pptovrd ss s wrarnereiai pr~titaat in sisrope. Only 10 Amesieani have used it.•and k may be yot;t't batot'e U.S. patieoott: hsvs the kind of sooeg to t4te Noysmr teetutolog+ that EW'o• •oaes hive today. Ljapt chis ctonth, an1Y two U.S. hospita!'s, Stat~- Sn;d Uttivaraia rrtd the Unirersity of Pitts~+ titugh, had basn pertniued to intplutt portable I+tovsta?r iytttetae. Reaently, the Mayo Ctlnie and three other U.S. inititutioni Were sdded to tbe list. .'Ile potetutal for the portable helri assist gu~,pfieat is enoiatauc, Fish year in the U•S., ' ,00a to 70,000 AQteriartc, llw Aadeatseher, `dtight be aottsidered good otsttdiditef !or a ;1(srt ersuespl:nt. Unfortunately, only about Z,040 trensplanu are pe4ornted every year. '.sa & reault, reseuchera are aearehing for altEr• "nattves, indudirtj a perrnsnent trti!'tasil heut 'or heart-auist devke that would n;tttain implanted indefinitely. ThtsE exponsive in- vestigitians &te alwtyt eoatTOverals). Advocuss ubue that in theory such an inno. ,vation could $atvs tttovsande of tive:; and bI~ lloas of dallus in kospitsl.bills and lost work . time. Cuireatly, the Novacor device is baN usad on ,s temporsty bzsis until a heat is 4vailsRlt for •transph+nt, but resezcebtre hope it toon will serva as the #irst devioe used perotnently tn Ucu of a traneplutt, "We're at the critical staSe where devioar an 4b1e to deliver whu we ttad hoped " said Dr. C:hristoplter McGrebor, direetor of tho Mayo Qinie's he&V tnd lunp tr~tlsnr prosrttm. "Yt rauidbe that Ibe quajity of liW wii! !se Wlood ,tlsst the puient woo't want anot}wr heart. ' Althou8h Mvo was vne of the few eenters in 0e United Stiru receritly asked to take part in etirtieal etudiaa of the portable Alevacor, MoGrerr would like to We been doina the research fooner. •'Cteuiy, titera's e ie+eral disappointment in •ihe U•S, etrdiosurSery commuaity with that •tead in Europe,° ht; Ona othar U•S. eornpsm besides Novteor is davaioptA6 t potttbls heart pump. The device ir 1wilabie at a limited nuasber of t3us in the U.S. It• hu been i:nplentsd in only 12 pacients and,' uatike lYcruaeor, is rsot eamracrt•sally tiv.il• •sbk srtywhtare in the llobts. !a the vie+v oE r sesrotzerz on iho other side oE the Atlsrstic, th~ raee for development af a per. manettt iatplctn wor 1e heatt pttrap wiU De ~ in fituopa by the nd of tfie year. If so, new. strostnlutad re lations in the Europe,n Union will tp d the now development to mar• kit RGi~Oif; the GS7tinentd utsiwtupstely,J it taay take yeus before the ssrne tcclsnol is widely uGed in the United Ststet -• the n t,on t6st used to be tsnrivaled ity deiivering te•of•the•en hasith aare• - AIERMIM , About,the series This serles wa written by the Star Tri- puna's W in ton bureau chief, -ibfi HantburQar, ~ tts aatlettal vcortomlt:s corrospor,dettt, Mike Meyers, Reportitty for the teriae was und.rwrtttert by a 'nnt trorn the Henry J. Kaiser pamlly Foundation, The project was supervised by tutlotatl Ed(tor Ropr Buoen and edit• ®d by Astsls t Nattonal fidhOt' Miko PaCltilak rsphte:a and page dsagpn w+sn dona y 611iy Stwe Clsyton, R.s+sareh a istancs was; provlasd by Aa/sr.rm brsrlan Sylvia Fdsah sind tM sbft ot the ur htbune itiarsry, attd by Jsnrtiier 9 'ss let Francs ansi Karen Kinder In t3~.rrnsny,