Isigulana sisetyhini esineminyaka engama-74 ubudala esandula kulaliswa esibhedlele ngenxa yokungaphumeleli kwentliziyo ekhohlo, kunye ne-fibrillation eqhubekayo ye-atrial, uxinzelelo lwegazi, isifo seswekile kunye nezinye izigulo zonyango. Utyando luhambe kakuhle ngokubekwa kwindawo efanelekileyo kunye nesiphumo esihle sasemva kwenkqubo. I-mitral valve regurgitation yapheliswa ngokukhawuleza emva kwenkqubo ngaphandle kokuphazamiseka kwe-LVOT. Isigulane siye sachacha kakuhle, kwaye sadluliselwa kwiyunithi yokunyamekela kakhulu (ICU) kwiwadi eqhelekileyo ngosuku olulandelayo kunye nomsebenzi oqhelekileyo wenhliziyo. Uye waphuma esibhedlele nge-30 kaDisemba, 2021. Le nkqubo iphumeleleyo iye yabeka isiseko esiluqilima kwiimeko zonyango zexesha elizayo zenkqubo kaPeijia's HighLife TSMVR eTshayina.
"Uyilo olukhethekileyo lwe-'Valve-in-Ring' luyenza ilungele uluhlu olubanzi lwe-mitral valve anatomy." watsho uNjingalwazi uMao Chen. "Uninzi lwezigulana aluyi kufuna ukuvalwa kwesiphene se-atrial septal emva kokugqabhuka kwe-transseptal nge-30F yokuhambisa i-catheter, kwaye ukubakho kweengxaki ze-vascular zisezantsi. Inkqubo yenziwa phantsi kwe-DSA eqhelekileyo ngokubambisana ne-echocardiogram, eya kukhuthaza ukwamkelwa kobu buchwepheshe. Ndiyathemba ukuba le teknoloji ingasetyenziselwa ukusetyenziswa ngakumbi kweklinikhi kwixesha elizayo ukuze kuxhamle izigulana ezinokubuyiselwa kwe-mitral. "
Itekhnoloji ye-HighLife ibonelela ngeempawu ezizodwa zokunyanga ukungoneli kwevalve ye-mitral
I-Transcatheter Mitral Valve Replacement ("TMVR") sele ihamba phambili kwintsimi yonyango lokungenelela kwi-structural heart disease. Izifundo zophononongo zakwangoko zibonakalise ukhuseleko kunye nokusebenza kobu bugcisa. I-TMVR ifanelekile kwiimpawu ezibanzi ze-anatomical ye-mitral regurgitation ("MR"). Inokunciphisa okanye ikhuphe ngokupheleleyo i-regurgitation kwaye iziphumo zesigulane zihlala zizinzileyo. Ngaphaya koko, i-TMVR ayingeneleli kangako kwaye inokwenziwa kubantu abadala okanye kwizigulane ezisengozini enkulu xa kuthelekiswa nokutshintshwa kotyando.
Nangona kunjalo, intsimi ye-Mitral Valve Replacement isajongene nobunzima obuninzi bezobugcisa, kubandakanywa ukufikelela kwindawo ekujoliswe kuyo, i-anchoring kunye nomngcipheko wokuvuza kwe-paravalvular ("PVL") kunye nokuphazamiseka kwe-LVOT. Uninzi lweendlela ezikhoyo zise-transapical okanye i-ankile kusetyenziswa amandla eradial. I-Transapical TMVR inokukhokelela ekubeni buthathaka komsipha wodonga lwe-ventricular yasekhohlo okanye ukusilela ekubetheni kwe-ventricular yasekhohlo ngenxa yokusikeka kotyando. I-TMVR i-anchoring kunye ne-radial force ingabangela ubungakanani obukhulu be-valve kunye nobunzima bokuhanjiswa, oku kunokukhokelela ekubuyiseleni i-ventricular reverse remodeling. Inkqubo ye-TSMVR ye-HighLife isebenzisa ingcamango eyodwa "I-Valve-in-Ring" enokumelana kangcono nale mingeni. Le nkqubo yahlula ivalve kwiringi yayo yokubambelela kwaye ihambisa amacandelo amabini nge-femoral vein kunye ne-femoral artery ngokulandelanayo.
Yinkqubo elula enamanyathelo amathathu. Okokuqala, iluphu yocingo ekhokelayo ibekwa kwindawo ejikeleze amaphecana evalvu yesigulana kunye nechordae. Okwesibini, i-anchoring ring ifakwe. Ekugqibeleni, ivalve yebhovine pericardial ezandisayo ikhutshwa ngokufikelela kwi-transseptal. Ivalve ehanjiswayo iqiniswe ngokudibana ize ke ifike kwindawo elinganayo ngeringi ebimiswe ngaphambili. Oku kuvumela i-valve ukuba ihlale kwindawo ezinzile ngaphandle kokonakalisa izicubu zokuqala. Inkqubo ilula kakhulu njengoko inkqubo izimele kwaye ilungelelanise. Uyilo lwesixokelelwano lunceda ukunciphisa umngcipheko wokuvuza kweparavalvular kunye nokunciphisa ngokufanelekileyo ubungakanani becatheter. Inkqubo ingagqitywa ngempumelelo ngokusebenzisa inkxaso ye-teleproctoring.
I-Peijia Medical ibonise amandla ayo kwintsebenziswano yamazwe ngamazwe kunye nobuchule bobugcisa
NgoDisemba ka-2020, i-Peijia Medical yangena kwisivumelwano selayisensi ne-HighLife SAS, inkampani esekwe eFransi yezixhobo zonyango, ngokulandela i-HighLife SAS inike i-Peijia Medical ilayisenisi eyodwa yokuphuhlisa, ukwenza kunye nokuthengisa iimveliso ezithile zobunini ze-TMVR kwingingqi yase-Greater China. Olu tshintshiselwano lobugcisa lwaqukunjelwa kwikota yesithathu ka-2021. Ukwenziwa kwemveliso yasekhaya enemigangatho ephezulu eTshayina iye yamiselwa: isixhobo se-HighLife esiveliswe yi-Peijia Medical saphumelela zonke iimvavanyo zokusebenza ezibonisa ngokulingana ne-HighLife SAS. Ukususela ekuqaleni kokudluliselwa kweteknoloji ukuya kufakelo lokuqala kuvavanyo lweklinikhi yophando e-China, i-Peijia Medical ithathe ngaphantsi konyaka omnye ukugqiba inkqubo ebonisa amandla ayo kwintsebenziswano yamazwe ngamazwe kunye nobuchule bobugcisa.
Ukukhawulezisa ukusetyenziswa kobu buchwepheshe buhamba phambili kwihlabathi kwiinzuzo zezigulane ze-MR e-China, abacebisi be-Peijia Medical, uNjingalwazi Nicolo Piazza kunye noNjingalwazi uJean Buithieu ovela kwiZiko lezoNyango leYunivesithi yaseMcGill eCanada, kunye neengcali zobugcisa ezivela kwi-HighLife SAS zisebenze ngokusondeleyo kunye ne-Peijia. Medical ukulungiselela olu lingo lwezonyango. Iiseshoni zoqeqesho ezininzi ezibandakanya isixhobo esinxulumeneyo kunye nokuziqhelanisa nonyango ziye zaqhutywa kwaye ii-Cardiologists e-China nazo zathatha inxaxheba ngokukhutheleyo kwinkqubo yokuqinisekisa ukufakwa okuyimpumelelo.
UGqr Nicolo Piazza wacinga kakhulu ngale ntsebenziswano kunye nokufakelwa ngempumelelo. “Ndivuya kakhulu kwaye ndinelunda ukuxhasa uNjingalwazi Mao Chen kunye neqela lakhe ukude ukuba baqhube inkqubo ye-HighLife TSMVR kwaye babelane ngamava am obugcisa. Ndiphinde ndamangaliswa bubuchule obugqwesileyo kunye nentsebenziswano ecwangcisiweyo kaNjingalwazi uMao Chen kunye neqela. Ndonwabile kakhulu ngokufakelwa ngempumelelo kwenkqubo yokuqala ye-TSMVR e-Asia. Ndikholelwa ukuba inkqubo ye-HighLife TSMVR inokunceda izigulana ezininzi kwixesha elizayo, kwaye ndijonge phambili kuphuhliso olomeleleyo kwicandelo lonyango longenelelo lwe-mitral valve.
Ukubambelela kumbono wayo "Ukuzinikela kwiNtliziyo, ukuhlonela uBomi", iPeijia Medical izama ukuphucula umgangatho wobomi bezigulane ngokuhlola iteknoloji kunye nokuzingisa okutsha. “Sibone uphando olongezelelekileyo malunga nendlela itekhnoloji ye-TMVR ejolise ngayo kwimingeni ephuma kwi-anatomy entsonkothileyo yevalve ye-mitral kunye nobunzima besi sifo. Le migudu eqhubekayo ibonisa ukubaluleka konyango lwe-TMVR, "kusho uDkt Michael Zhang Yi, uSihlalo kunye ne-CEO ye-Peijia Medical. “Nangona indlela ye-transseptal iyindlela ekhethwayo kwaye igqwesa ngeendlela ezininzi, uninzi lwetekhnoloji esele ikho ye-TMVR zisasebenzisa indlela yokudlula. I-HighLife SAS yinkokeli yehlabathi kubuchwepheshe be-TSMVR, eneziphumo ezithembisayo zolingo lwezonyango ezipapashwe kwi-TCT 2021 kunye ne-PCR London Valves 2021. Enkosi kuNjingalwazi uMao Chen kunye noNjingalwazi uNicolo Piazza ngentsebenziswano yabo kufakelo lokuqala lwe-Peijia's HighLife System, ukufakelwa ngempumelelo. iye yomeleza ngakumbi ukuzithemba kwethu ekunyangeni izifo zevalve ye-mitral ngobuchwephesha bongenelelo obungenabungozi ngokwenene. IPeijia Medical izakuqhubeka nokuzinikela kwethu ekuveliseni izinto ezintsha, ngethemba lokuba abaguli abaninzi baseTshayina abagula sisifo se-mitral valve banokuxhamla kule nkqubela phambili yetekhnoloji. ”
Inkqubo ye-TSMVR ye-Peijia ye-HighLife imele unyango lwe-mitral valve interventional, oluya kuphucula kakhulu umgangatho wobomi bezigulane zaseTshayina ezine-MR enzima. Inkolelo ye-Peijia Medical "yokubeka ubomi bezigulane kunye nokhuseleko kwindawo yokuqala ngokuqhubela phambili uphuhliso lonyango olungephi oluhlaselayo ekhaya naphesheya" ayizange itshintshe.
INTO ONOKUYITHATHA KWELI NQAKU:
- To expediate the use of this world-leading technology for the benefits of MR patients in China, Peijia Medical’s consultants, Professor Nicolo Piazza and Professor Jean Buithieu from McGill University Medical Center in Canada, and the technical experts from HighLife SAS worked closely together with Peijia Medical to prepare for this clinical trial.
- From the start of the technology transfer to the first implantation in research clinical trial in China, Peijia Medical took less than one year to complete the process which demonstrated its capability in international collaboration and technical expertise.
- In December 2020, Peijia Medical entered into a license agreement with HighLife SAS, a France based medical device company, pursuant to which HighLife SAS has granted Peijia Medical an exclusive license to develop, manufacture and commercialize certain proprietary TMVR products in the Greater China region.
