NgoDisemba 2, 2021, i-BD (inkampani ye-bidi) yamemezela ukuthi isithole inkampani ye-venclose. Umhlinzeki wesixazululo usetshenziselwa ukwelapha ukungasebenzi kahle kwe-venous (CVI), isifo esibangelwa ukungasebenzi kahle kwe-valve, okungaholela emithanjeni ye-varicose.
I-Radiofrequency ablation iwukwelashwa okuyinhloko kwe-CVI futhi yamukelwa kabanzi odokotela. Uma kuqhathaniswa nokwelashwa okuhlukile nge-laser kwe-CVI, ukukhishwa kwe-catheter ye-radiofrequency kungase kunciphise ubuhlungu bangemva kokuhlinzwa kanye nemihuzuko. UVinclose ungumholi emkhakheni we-CVI therapy. Inkundla yayo yobuchwepheshe bokukhipha imvamisa yomsakazo (RF) entsha ihlose ukuzuza ukuguquguquka, ukusebenza kahle kanye nokuba lula.
Umugqa wokukhipha imithambo oweluliwe
I-CVI imele isidingo esibalulekile nesikhulayo sokwelashwa ngaphakathi kwesistimu yokunakekelwa kwezempilo - ethinta kufika ku-40% wabesifazane kanye no-17% wamadoda e-United States. UVinclose ungumholi emkhakheni we-CVI therapy. Inkundla yayo yobuchwepheshe bokukhipha imvamisa yomsakazo (RF) entsha ihlose ukuzuza ukuguquguquka, ukusebenza kahle kanye nokuba lula. I-Radiofrequency ablation iwukwelashwa okuyinhloko kwe-CVI futhi yamukelwa kabanzi odokotela. Uma kuqhathaniswa nokwelashwa okuhlukile nge-laser kwe-CVI, ukukhishwa kwe-catheter ye-radiofrequency kungase kunciphise ubuhlungu bangemva kokuhlinzwa kanye nemihuzuko.
"Sizibophezele ekubekeni izinga elisha lokusebenza kahle ezigulini ezinezifo ze-venous, okudinga kuqala ukuhlinzeka ngobuchwepheshe obusha kodokotela," kusho u-paddy O'Brien, umongameli womhlaba jikelele we-BD peripheral intervention. "Ukuthola kwethu i-venclose kuzosenza sikwazi ukunikeza iphothifoliyo enamandla kakhulu yezixazululo kodokotela abelapha izifo ezehlukene ze-venous. I-Venclose ™ Uhlelo lokukhipha ama-radiofrequency ablation luhambisana kahle nephothifoliyo yethu ehamba phambili yobuchwepheshe bezifo ze-venous futhi luhambisana nokugxila kwethu ekusunguleni kanye ukuhlinzeka ngezixazululo eziguquguqukayo zokuthuthukisa ukwelashwa kwezifo ezingamahlalakhona nokwenza ukuguqukela endaweni entsha yabahlengikazi kwenzeke.
I-Venclose ™ Idizayini ehlangene yesistimu inikeza osayizi ababili bobude bokushisisa (2.5 cm no-10 cm) ku-catheter engu-6 Fr. Le catheter yobude obushisayo obuphindwe kabili ihlinzeka odokotela ngezinzuzo ezihlukahlukene zokusebenza.
I-Venclose ™ Ubude bokushisisa besistimu bubude ngo-30% kunalolo lwe-catheter yokukhipha i-radiofrequency ablation ende yokuncintisana ende kakhulu, okuvumela odokotela ukuthi bakhiphe ngempumelelo imithambo eminingi kumjikelezo wokushisisa ngamunye futhi kusize ekwehliseni inani eliphelele lokukhishwa kwe-ablation edingekayo ekwelapheni ngomthambo. Ubude bokushisisa obukabili busho ukuthi odokotela bangasebenzisa i-catheter efanayo ukuze bacime amasegimenti e-venous amade namafushane - ukwehlisa umthwalo wokuphathwa kwe-inventory uma kuqhathaniswa nama-catheter anosayizi abafushane kanye/noma obude bokushisa obumile.
Ubuchwepheshe besistimu futhi buklanyelwe ukusiza ukunikeza indlela egxile esigulini ekunakekeleni. Isibonelo, isibonisi sayo sesikrini esithintwayo sinikeza idatha yohlelo lwesikhathi sangempela ukusiza ukwazisa odokotela ngezinqumo zokwelashwa. Uhlelo luphinde lunikeze ithoni ezwakalayo yokudlulisa ukushisa - okuvumela udokotela ukuthi agxile isikhathi esiningi nokunaka esigulini.
I-Vinclose yasungulwa ngo-2014 ukuze kuthuthukiswe ukwelashwa kwe-CVI ngobuchwepheshe bokukhishwa kwe-radiofrequency ablation. Kusukela lapho, inkampani izibophezele ekuhlinzekeni inqubekelaphambili yezobuchwepheshe kanye nokusebenza kahle kwezinqubo kodokotela abelapha i-CVI, kuyilapho futhi besiza ukuthuthukisa ukwaneliseka kwesiguli. I-Venclose ™ Uhlelo lungasetshenziswa ezikhungweni zokunakekelwa kwezempilo ezehlukene e-United States naseYurophu. Imigomo yokwenziwayo ayizange idalulwe. Okwenziwayo kulindeleke ukuthi kungabi nalutho ekusebenzeni kwezimali kwe-BD ngo-fy2022.
Imakethe yezigidigidi eziyishumi
Ngo-2020, imakethe yomhlaba wonke yemishini yezokwelapha yemithambo kulindeleke ukuthi ifinyelele e-US $8.92 billion (elingana no-RMB 56.8 billion), kanti i-United States iseyimakethe enkulu kunazo zonke emhlabeni. Ukungenelela kwe-venous kuyingxenye yemakethe yokungenelela yangaphandle, futhi imakethe yokungenelela ye-venous yasekhaya ikhula ngokushesha. Ngo-2013, izinga lemakethe lamadivayisi okungenelela e-venous e-China lalingama-yuan ayizigidi ezingama-370 kuphela. Ngo-2017, isilinganiso semakethe sokungenelela kwe-venous sikhuphuke safinyelela ku-RMB 890million. Lo mkhuba wokukhula ngokushesha uzokhuphuka ngokushesha ngokukhula kokungenelela kwe-venous ekusetshenzisweni komtholampilo. Ngo-2022, isikali semakethe sizofinyelela ku-RMB 3.1 billion, ngenani lokukhula elihlanganisiwe lonyaka lama-28.4%.
Ngokwezibalo, abantu abayi-100000-300000 babulawa yi-venous thrombosis minyaka yonke e-United States, futhi abantu abangama-500000 babulawa yi-venous thrombosis minyaka yonke eYurophu. Ngo-2019, inani leziguli ze-varicose vein eChina lafinyelela ku-390million; Kuneziguli eziyizigidi ezingu-1.5 ezine-venous thrombosis ejulile; Izinga lezigameko zokucindezelwa kwe-iliac vein lingama-700000 futhi kulindeleke ukuthi lifinyelele ku-2million ngo-2030.
Ngokuqoqwa okujulile kwama-coronary stents, ukugxilwa kokungenelela kwemithambo kushintshile kusuka ku-coronary artery kuya emithanjeni ye-neurovascular kanye ne-peripheral. Ukungenelela kwe-peripheral kuhlanganisa ukungenelela kwe-peripheral arterial kanye nokungenelela kwe-peripheral venous. Ukungenelela kwe-venous kuqale sekwephuzile kodwa kwakhula ngokushesha. Ngokusho kokubalwa kwezibambiso zezimboni, inani lemakethe lamadivayisi wokungenelela we-venous waseChina ikakhulukazi ekwelapheni izifo ezijwayelekile ze-venous njengemithambo ye-varicose, i-deep venous thrombosis kanye ne-iliac vein compression syndrome cishe ezigidigidi eziyi-19.46.
Le makethe eseduze, ezodlula ama-yuan ayizigidi eziyizinkulungwane eziyi-10, ihehe imidondoshiya yamazwe ngamazwe njenge-BD, i-Medtronic ne-Boston science. Bangene emakethe kusenesikhathi, banamabhizinisi amakhulu futhi benze ulayini wemikhiqizo ocebile. Amabhizinisi endawo nawo avuke elandelana. Amabhizinisi afana nobuchwepheshe be-Xianjian kanye ne-guichuang Tongqiao agcine amapayipi acebile e-R & D emkhakheni we-vein.
Iphethini yokukhishwa kwemithambo yasekhaya
Ngokumiswa kokuhlinzwa okuhlasela kancane imithambo ye-varicose, ukwelapha okuhlasela kancane kuzothatha indawo yokuhlinzwa okuvamile, futhi umthamo wokuhlinzwa uzokwanda ngokushesha. Phakathi kwezindlela zokwelapha ezihlasela kancane, i-radiofrequency ablation (RFA) kanye ne-intracavitary laser ablation (EVLA) izindlela ezimbili ezifakazelwe zokukhipha isisu. I-RFA yenza ngaphezu kuka-70% we-intracavitary thermal ablation e-China ngo-2019. Njengamanje, kunezinhlelo ezimbili ezivunyiwe zokukhishwa kwe-radiofrequency e-China. Kukhona ikakhulukazi ama- peripheral radiofrequency ablation catheter athengiswayo e-China, enziwa amabhizinisi angaphandle, okungukuthi, ukuvala ngokushesha nokuvala ama-RF e-Medtronic kanye ne-evrf intravenously radiofrequency closure system of F care systems NV.
Indlela emisha yemikhiqizo ye-radiofrequency ablation igxile ekwehliseni izinkinga. Izinkinga eziyinhloko zemikhiqizo ekhona ye-radiofrequency ablation ukushiswa kwesikhumba, ukuhlukana kwemithambo, i-subcutaneous ecchymosis nokuvuvukala, kanye nokulimala kwenzwa ye-saphenous. Ukulawulwa kwamandla, umjovo ongaphansi kwesikhumba woketshezi oluvuvukalayo kanye nokwelashwa kwengcindezi eqhubekayo kunganciphisa ngempumelelo ukuvela kwezinkinga. Ukukhishwa okushisayo kudinga i-anesthesia ye-tumescent ngaphambi kokulethwa kwamandla, okungase kubangele ukungakhululeki esigulini futhi kungase kunwebe isikhathi sokusebenza.
Ngenxa yalesi sizathu, i-Medtronic igxile ku-venaseal, umkhiqizo wokuvala ukushisa okuvamile. Umgomo walolu hlelo lokuvala ukusebenzisa i-catheter ukujova okunamathelayo emthanjeni ukuze kuzuzwe umphumela wokuvala umthambo. I-Venaseal yagunyazwa yi-FDA ukuthi ifakwe kuhlu ngo-2015. Eminyakeni yamuva nje, isibe yindawo yokukhula eyinhloko yebhizinisi le-Medtronic le-peripheral. Njengamanje, lo mkhiqizo awukafakwa ohlwini e-China.
Njengamanje, amabhizinisi asekhaya agxile ekwenziweni kwasendaweni kwemikhiqizo ye-radiofrequency ablation ye-varicose vein ablation futhi anciphise izinkinga zemikhiqizo yokukhishwa kwe-thermal; Uhlelo oluguquguqukayo, olulawulekayo noluhlakaniphile lwe-radiofrequency ablation luzonciphisa kakhulu ubunzima bokusebenza, futhi luyisiqondiso esibalulekile sokuthuthukiswa komkhiqizo. Amabhizinisi wasekhaya we-R & D wemikhiqizo yokukhishwa kwe-radiofrequency ahlanganisa i-xianruida nebhuloho le-guichuangtong. Isidingo semakethe esingagculisekile sishukumisela amabhizinisi amaningi ukuthi ahlangane kule threkhi, futhi ukuncintisana kulo mkhakha kuzoshuba ngokuzayo.
Ngokombono wabahlanganyeli basekhaya, iphethini yokuncintisana yemakethe yokungenelela emithanjeni yasekhaya nayo isivele ekuqaleni. Abahlanganyeli abakhulu bahlanganisa amabhizinisi ezizwe ngezizwe amelwe i-Medtronic, i-Boston science kanye ne-bidi medical; Abaholi basekhaya abamelwe yi-xianruida ne-Xinmai medical, kanye nenani labasafufusa abasafufusa.
Isikhathi sokuthumela: Jun-28-2022