Zvigadzirwa Zvinopindirana Nemwoyo: Kugadzira Zvinhu Zvitsva uye Kubudirira Kuchinja Indasitiri

Nhanganyaya: Kupindira Kwemwoyo Munguva Yekurapa Kwakanyatsonaka

Zvirwere zvemwoyo zvichiri chimwe chezvinhu zvinonyanya kukonzera njodzi pasi rose. MuChina, vanhu vanosvika mamiriyoni mazana matatu nemakumi matatu vanotambura nezvirwere zvemwoyo, kusanganisira vanosvika mamiriyoni gumi nerimwe negumi nematatu vane chirwere chemwoyo (CAD). Pakati pekukurumidzira kukwegura kwevanhu uye kushandiswa kwemishonga isinganyanyi kupararira, zvigadzirwa zvemwoyo zviri kuchinja nekukurumidza kusati kwamboitika. Kubva pahurongwa hwekuti "usasiye chinhu" hwemabharuni ane mishonga kusvika pakubudirira mu intravascular lithotripsy (IVL), kubva pakubvumidzwa kwemoyo wekutanga wemukati menyika kusvika pakushandiswa kwekiriniki kwemarobhoti ekuvhiya evascular, nhevedzano yezviitiko zvinoratidza kuti kurapwa kwemwoyo kwapinda muchikamu chitsva. Panguva imwe chete, mitemo yekutenga zvinhu (VBP) iri kuramba ichichinja mamiriro eindasitiri, kuchinjana kwemukati menyika kuri kuwedzera, uye chikamu chemoyo chiri kufamba kubva "kubudirira kwedata" kuenda ku "kugadzira kukosha".

Chinyorwa chino chinoongorora zvakarongeka kufambira mberi kwazvino muzvigadzirwa zvekurapa chirwere chemwoyo muzvikamu zvitatu: matanho makuru ezvigadzirwa munguva pfupi yapfuura, miganhu yekuvandudzwa kwetekinoroji, uye mafambiro enzvimbo yeindasitiri.

I. Zviitiko Zvikuru Zvichangoburwa: Zviitiko Zvinogara Zvichiitika

1. Mwoyo Wekugadzira Wemukati: Kubvumidzwa Kwekutanga Munyika, Musika Wemabhiriyoni Zana Wakatangwa Zviri Pamutemo

Muna Zvita 2025, moyo wekugadzira wakagadziriswa neShenzhen Core Medical Technology Co., Ltd. wakapihwa mvumo kubva kuNational Medical Products Administration (NMPA), ukava chigadzirwa chekutanga chakatenderwa munyika. Sisitimu iyi inoshandisa tekinoroji yeaxial-flow motor yekutsigira ventricular yekuruboshwe kwenguva pfupi. Se tekinoroji yekutanga yemuno, inozadza mukaha wakakura muchikamu chemidziyo yekubatsira cardiac yepakati muChina.

Mwoyo yekugadzirwa inoshandiswa zvakanyanya mukurapa chirwere chemwoyo (PCI) chine njodzi huru uye zvirwere zvakakomba zvakaita se cardiogenic shock. Pasi rose, Abiomed's Impella series ndiyo chigadzirwa chemuenzaniso mune izvi, ine maapplication anodarika 400,000 pasi rese uye mari inowanikwa mugore ra2025 inosvika 1.751 bhiriyoni, zvichiratidza kusimba kwekukura. Kutengwa kweAbiomed neJohnson neJohnson kwe16.6 bhiriyoni muna 2022 kwakaratidzawo kukosha kukuru kwebhizinesi rechikamu ichi.

Zvinonyanya kukosha kuti, pamusoro pechigadzirwa chakatenderwa neCore Medical, makambani anopfuura gumi emuno ari kugadzira mwoyo yekugadzira inopindirana. Mazhinji acho akapedza bvunzo dzekiriniki kana kuti ari kuda kupera, aine mukana mukuru wekuwana mvumo yeNMPA muna 2026. Gore ra2026 rinotarisirwa kuva "gore rekubvumidzwa pamwe chete" kwemoyo yekugadzira inopindirana, zvichichinja mamiriro emusika wemamiriyoni emadhora.

2. Ultrasound yeMutsinga: Catheter yeMumba ye60 MHz Yakagamuchirwa, Kuwedzera Chishandiso Chitsva chePCI Yakanyatsogadzirwa

Musi wa13 Kurume 2026, Boston Scientific yakazivisa kuti catheter yayo yekuongorora ultrasound (IVUS) inoraswa, OptiCross™ HD, yakanga yatenderwa neNMPA uye yaizogadzirwa munharaunda yayo panzvimbo yayo yekugadzira Lingang muShanghai. Ichi chakava chishandiso chekutanga chekurapa chakagadzirwa neBoston Scientific chakatenderwa pafekitori yayo yekugadzira muChina.

OptiCross™ HD ndiyo yekutanga 60 MHz high-definition IVUS catheter yakatenderwa muChina. Inoshandisa tekinoroji yepamusoro yecomposite transducer uye broadband, ichipa mifananidzo ine resolution yepamusoro uku ichichengetedza kupinda kwakanaka kwematishu. Inonyatsoona chimiro chemadziro etsinga uye plaque morphology, ichibatsira vanachiremba kuongorora maronda nemazvo uye kugadzirisa nzira dzekurapa, nokudaro ichivandudza kushanda zvakanaka kwemaitiro uye mhedzisiro yekurapa.

IVUS inowanzonzi "ziso rechitatu" revanachiremba vanopindira muropa uye yave "chiyero chitsva" chekuongorora tsinga dzeropa. Zvisinei, mwero wekushandiswa kweIVUS pari zvino mukurapa kwePCI muChina ungangoita 18% chete, wakaderera zvakanyanya pane anopfuura 50% munyika dzakabudirira uye 90% muJapan. Nekugadzirwa kwemuno, mukana wekuwana tekinoroji yeIVUS yepamusoro-soro unotarisirwa kuvandudzika zvikuru, zvichikonzera kushandiswa kwakakura kwePCI chaiyo.

Munguva imwe chete iyoyo, mudziyo wekurapa we ultrasound wemukati meropa uye waya yekurapa ye ultrasound yemukati meropa yakagadzirwa neShanghai MicroPort Rhythm Medical Technology Co., Ltd. yakagamuchirawo mvumo yeNMPA. Chigadzirwa ichi chinoshandisa tekinoroji ye piezoelectric ultrasonic frequency mechanical vibration uye ndiyo yekutanga system ye ultrasonic guidewire inoshandisa mechanical vibration kurapa coronary chronic total occlusion (CTO) loses.

3. Nguva Yakapfupikiswa yeDAPT yeCoronary Stents: HT Supreme™ yeSino Medical Yagamuchira Mvumo yeEU

Musi wa20 Chivabvu, 2026, Sino Medical Sciences Technology Inc. yakazivisa kuti sisitimu yayo yeHT Supreme™ drug-eluting stent (DES) yakagamuchira mvumo yeEuropean Union yeDAPT (dual antiplatelet therapy) kwenguva pfupi semwedzi mumwe chete mushure mekuisirwa muvarwere vese veCAD. Mvumo iyi yakavakirwa paongororo yekiriniki yekambani mushure memusika, PIONEER IV, ine mhedzisiro yepakati yakaburitswa muEuropean Heart Journal muna Kukadzi 2026.

Kubvumidzwa uku kunoratidza danho rakakosha mukuvandudza mishonga yekurapa mushure mekuvhiyiwa kwemoyo pasi rose, zvichibatsira kuderedza njodzi yekubuda ropa uye mutoro wehupfumi unobatanidzwa nekurapa kwenguva refu kweantiplatelet, ukuwo zvichiwedzera kukwikwidzana kwechigadzirwa ichi muEurope nemisika yepasi rose.

4. Zvimwe Zvibvumirano Zvakakosha

Sisitimu yeConcave Supra integrated arch triple-branch reconstruction system, yakagadzirwa pamwe chete naLifetech Scientific naProfessor Chang Shu vekuFuwai Hospital, yakapinda muNMPA Innovative Medical Device Special Review Process. Ichi chigadzirwa chekutanga pasi rose chinopa mhinduro isina cerebral-ischemia integrated yekuvakazve triple-branch arch, yakakodzera kurapwa kushoma kweaneurysms dzakaoma dzeaortic arch uye maronda anopinda. Kutevera kwemwedzi gumi nemiviri kubva kuongororo dzekuita kwakaratidza kusanganiswa kwakanaka kwestent kuaortic arch nebranch arteries, hapana endoleak, patency yebranch arteries dzese, uye hapana zviitiko zvakaipa.

Pamusoro pezvo, Acotec Scientific's coronary over-the-wire (OTW) balloon dilation catheter (Jingyi) yakagamuchira mvumo yekunyoresa yeNMPA; MicroPort Endovascular's peripheral vascular microcatheter (Torqueflex/Linglong Tube) yakatenderwa kutengeswa; uye NMPA yakatendera zvigadzirwa zvakawanda zvitsva, zvinosanganisira transcatheter aortic valve systems, transcatheter mitral valve clip systems, uye biodegradable patent foramen ovale (PFO) occluder systems, zvichiratidza kuti kuvandudzwa kwakasimba kuri kuramba kuripo muchikamu chemukati memoyo.

II. Miganhu Yekuvandudza Tekinoroji: Kubva "Kusiya Chero Chinhu" Kuenda kuChimurenga Chehungwaru

1. Intravascular Lithotripsy (IVL): Kubvisa Bottleneck muCalcified Lesion Treatment

Maronda emwoyo anokonzerwa ne calcium ave kwenguva refu ari "nzira yakaoma yekupwanya" mukurapa kwe interventional. Mabharuni anowanzo kundikana kuwedzera zvizere ma calcified plaques, uye nzira dzechinyakare dzinosangana nematambudziko akadai sekuoma kwemaitiro uye njodzi huru dzezvinetso. IVL inoshandisa nenzira itsva musimboti we lithotripsy kubva ku urology kuenda ku vascular field, ichipa simba re pulsatile sonic kuti iparadze calcium yakadzika mu intima ne media uku ichideredza kukuvara kwenyama yakajairwa.

Sisitimu yeGrand Pharmaceutical yeDEEPQUAKE-C coronary IVL system yakagamuchira mvumo yeNMPA munguva pfupi yapfuura, zvichiwedzera "bhokisi rezvishandiso" zvekurapa calcium usati watanga uye zvichibatsira kupindira kwemoyo kupinda muchikamu chitsva che "precision calcium modification".

BlueSail Medical inoshandawo zvakanyanya munzvimbo iyi. Sonicracker™ coronary IVL system yayo ine zvinhu zvitsva zvinosanganisira bharuni rine mativi maviri, catheter ine dhayamita yakawanda, uye ma electrode epatch-convex ring, zvichibudirira mukudzivirira kumanikidzwa, kufambiswa kwemuchina, uye kugoverwa kweacoustic pressure. Muna Nyamavhuvhu 2025, BlueSail Medical yakatanga chidzidzo chekiriniki cheSONICURE, chidzidzo chekutanga chekiriniki cheIVL pasi rose chakanangana ne in-stent restenosis (ISR). Iyi bvunzo inodzorwa, ine nzvimbo dzakawanda, isina kurongeka, ine chinangwa chekuzadza mipata yakakosha yehumbowo hweIVL mukurapa ISR inokonzerwa ne calcification yakanyanya.

2. Marobhoti Ekuvhiya Anoshanda Pakuvhiya: Kufambira Mberi Mhinduro dzeSimba uye Ungwaru

Marobhoti ekuvhiya ndiwo mamwe ematanho anotarisirwa zvikuru mukurapa chirwere chemwoyo. Pamusangano wegore negore weZhongguancun Forum we2026, Wego Medical yakaratidza robhoti rekuvhiya rakagadzirwa munyika, iro raive rekutanga kubvumidzwa kutengeswa muChina uye rine kugona "kwekupa mhinduro". Rinogona kuunganidza masimba ekubatana panguva chaiyo pakati pezvishandiso nemadziro etsinga, richitumira chiratidzo kuna chiremba pasina kunonoka, nekunyatsonzwisisa kwesimba re0.01 N (inenge 1 gram yakaenzana). Sisitimu iyi inotsigira kushanda kure, ichibvumira vanachiremba kushanda vasina maapuroni emutobvu, zvichideredza zvakanyanya kuratidzwa kwemwaranzi.

MunaKurume wegore rimwe chete, XCath, kambani yemarobhoti anobatsira mutsinga dzeropa, yakazivisa kupedzwa kwechirongwa chemari inosvika mamiriyoni makumi matatu emadhora (inenge RMB mamiriyoni mazana maviri negumi) cheSeries C, ichitungamirwa nesangano rekudyara mari reMiddle East Crescent Enterprises uye "baba vemarobhoti ekuvhiya". Mari yese yakawanikwa yakasvika mamiriyoni makumi mapfumbamwe nemaviri emadhora. Chigadzirwa chikuru chekambani, iyo Iris vascular intervention robot system, yakabudirira kupedza kushandiswa kwayo kwekutanga mukurapa kwevanhu.

Pakuratidzwa kweCMEF kwechi93 muna Kubvumbi, MicroPort Group yakaratidza zvigadzirwa zvakakosha muzvikamu zvishanu zvikuru, zvichitarisa pakuvhiyiwa kwemarobhoti, kupindira kwemoyo, uye kurapwa kwezvirwere zvepan-vascular. Panguva iyi, Rayner Surgical Intelligence yakatanga robhoti rekuvhiya rinoshandisa AI zvizere, richiratidza kufambira mberi kwekubatanidzwa kwakadzama kweAI nemarobhoti ekuvhiya.

3. Mabharuni Akaputirwa Nemishonga uye Nzira Yekuti "Usasiye Chinhu"

Mabharumu ane mishonga (DCBs) ave nzira yakakosha mukupindira kwemoyo nekugonesa nzira yekuti "hapana-implant". Mutambo wechitanhatu weVBP yenyika (yeDCBs nezvigadzirwa zveurological access) wakatanga kushanda zviri pamutemo musi wa31 Chivabvu 2026. Mitengo yeDCBs yakahwina yaibva paRMB 1,677 kusvika paRMB 6,015, ichibatanidza vatambi vakuru vakaita saB. Braun, Boston Scientific, Acotec, Lepu, naGore. Mitengo yeDCB yaimbove iri pamusoro peRMB 20,000. Mushure memutambo uyu weVBP, mitengo yezvigadzirwa zvikuru yakajekeswa, zvichideredza zvakanyanya mutoro wemari pavarwere.

III. Hunhu hweMaindasitiri uye Mafambiro eMusika: Hukuru hweMusika Hunopfuura RMB 90 Bhiriyoni seKutsiva Kwemumba uye VBP Inochinja Nzvimbo

1. Kuwedzera Kwemusika Kunogara Kwenguva Refu

Musika wemidziyo yekurapa chirwere chemwoyo wekuChina uri kukura nekukurumidza. Zvichienderana nehuwandu hunobva kuGuangdong Research Center for Novel Biomaterials and High-End Medical Devices, huwandu hwekuwedzera kwegore negore (CAGR) hwemusika wemidziyo yekurapa chirwere chemwoyo wekuChina mumakore mashanu apfuura hwasvika 10.2%, uye hukuru hwemusika hunotarisirwa kudarika RMB 90 bhiriyoni muna 2026.

Pasi rose, musika wemidziyo yekurapa mwoyo uye zvinodyiwa uri kukurawo zvakanyanya. Ruzivo rwekutsvagisa neMisika runoratidza kuti musika wepasi rose wemidziyo yekurapa mwoyo unotarisirwa kukura kubva pamabhiriyoni gumi nemashanu nehafu muna 2025 kusvika pamabhiriyoni makumi maviri nerimwe nemazana manomwe nemazana manomwe nemazana manomwe nemazana matanhatu panosvika gore ra2030, paCAGR ye7.2%.

2. Kuchinjana Kwemumba Kunokurumidza

Kunyangwe musika uchikura nekukurumidza, chikamu chepamusoro-soro chinoramba chichitongwa nemakambani makuru epasi rose. Medtronic, Boston Scientific, nedzimwe dzine chikamu chinopfuura 60% chemusika wepamusoro-soro wemidziyo yemwoyo. Zvisinei, "kuchinja kwemitengo" muma "coronary stents" emuno kwave kunoshamisa - mitengo ye "stent" yakadzikira kubva pamusoro peRMB 10,000 kusvika paRMB 700, zvichiwana chikamu chemuno che95%. Mumunda weIVUS, kunyangwe Boston Scientific nePhilips dzichiri vatambi vaviri vepamusoro, Shenzhen Blinova Medical yakawana chikamu chemusika che18.02% nekutengesa kweinenge RMB 16 miriyoni, zvichiratidza kuwedzera kwevakwikwidzi vemuno.

Mukurapa kwemoyo, waya dzinofambisa mashoko nemacatheter zvichiri kusangana nedambudziko rekushomeka kwemari yekuchinjana mishonga mudzimba. Zvisinei, munzvimbo dzepamusoro dzakadai se cardiac electrophysiology nema transcatheter valves, hunyanzvi hwemudzimba huri kuwedzera. Zvishandiso zvekurapa zvitsva zvinosvika makumi manomwe nematanhatu zvakatenderwa muna 2025, kusanganisira masisitimu e multiple cardiac pulsed field ablation (PFA) akagamuchira mvumo yakawanda.

3. Kugadziriswa kweVBP ne "Anti-Involution"

Senyanzvi munyaya iyi, ha2026 inoonekwa se "gore rekuchinja magiya" kune VBP inodhura zvakanyanya. Mutambo wechitanhatu weVBP yenyika (DCBs, urological access) waitwa, nemitemo yakagadzirirwa zvakananga kurwisa "involution" (makwikwi emukati akawandisa) - kwete kungosarudza mutengo wakaderera wekubhadhara kuti uverenge mutsauko wemitengo, asi uchishandisa 65% yemutengo wepakati wekukunda sechiratidzo chekudzora mutsauko wemitengo kana bhidhi yakaderera yakaderera. Panguva imwe chete, mamwe mapurojekiti akawanda ari kufambira mberi, kusanganisira mubatanidzwa wepacemaker wemwoyo wepurovhinzi 27 VBP uye peripheral Kupinda kwetsinga dzeropa microcatheter VBP.

Kunyange zvazvo kudzikiswa kwemitengo kunounzwa neVBP kuchimanikidza purofiti yemakambani kwenguva pfupi, zvinomanikidzawo indasitiri iyi kuti ichinje kubva pakukura kwe "channel-driven" kuenda pakukura kwe "innovation-driven", zvichikurudzira kuwedzera kwekudyara muR&D, kukosha kwakanyanya kwekiriniki, uye kukurumidza kubvisa kugona kwechinyakare.

4. Mapuratifomu Edzidzo Anoenderera Mberi Anopa Simba Kuindasitiri

Senyanzvi munyaya iyiMuna Kubvumbi 2026, musangano wepagore wechi24 weChina Interventional Therapeutics (CIT 2026) wakaitwa muBeijing. Yakavambwa naProfessor Gao Runlin muna 2003, CIT yakura kubva pakupinda kwekutanga kwevanhu vanopfuura 890 kusvika yava imwe yemapuratifomu edzidzo yepasi rose ane simba rekurapa mwoyo munharaunda yeAsia-Pacific. Mapuratifomu epamusoro ekuchinjana dzidzo akadai seCIT anopa rutsigiro rwakakosha pakusimbiswa kwekiriniki, kuparadzira tekinoroji, uye kushandira pamwe kweindasitiri muzvigadzirwa zvekurapa mwoyo.

Maonero: Mugwagwa Uri Mberi Unotungamirirwa Nezvinhu Zvitsva

Zvigadzirwa zvemwoyo zvinopindirana netsinga dzeropa zviri pakutanga kweshanduko itsva yetekinoroji. Tekinoroji dzemazuva ano dzakadai semoyo dzekugadzira dzinopindirana, masisitimu eIVL, uye marobhoti ekuvhiya ari kufamba nekukurumidza kubva murabhoritari kuenda kukiriniki, zvichipa varwere dzimwe nzira dzekurapa. Panguva iyi, shanduko ye "anti-involution" mumitemo yeVBP uye kukurumidza kwekutsiva kwemuno kuri kuchinja pfungwa dzemakwikwi eindasitiri. Kukwikwidzana kukuru kwemabhizinesi kuri kuwedzera kuchinja kubva pakugona kwechiteshi uye mabhenefiti emitengo kuenda pakukwanisa kwakazara kunobatanidza kusiyana kwetekinoroji, humbowo hwekiriniki, uye mukana wekuwana musika.

Mumakore anotevera, musika wezvekurapa nemwoyo uchachinja zvikuru, zvichikonzerwa nekuvandudzwa kwetekinoroji uye nhungamiro dzemitemo. Makambani anowana budiriro dzinogara dziripo mukuongorora nekurapa kwakarurama, zvishandiso zvine hungwaru, uye kuvandudzwa kwakasiyana-siyana achawana nzvimbo dzakanaka muchikamu chinotevera chekubatanidzwa kweindasitiri. Sekukurudzirwa neGuangdong Research Center yeNovel Biomaterials neHigh-End Medical Devices, indasitiri yese inofanira kutarisana nedambudziko rayo rekukura, kunanga kuedza kwayo nemazvo, kuwana budiriro dzakasimba, uye kurwira shanduko huru kubva pa "kubudirira kwedata" kuenda ku "kugadzira kukosha".

Zvichitungamirirwa nehurongwa hwe "Healthy China", zvigadzirwa zvekurapa chirwere chemwoyo zvichava nyore kuwana, zvakachengeteka, uye zvine hungwaru, zvichipa dziviriro yakasimba kuhupenyu neutano hwemazana emamiriyoni evarwere vane chirwere chemwoyo.

Chiziviso: Chinyorwa ichi ndechekuzivisa vanhu nezvekurapa chete uye hachisi zano renyanzvi rezvekurapa. Ndapota garai muchitevera zvirongwa zvekuongorora chirwere uye zvekurapa zvinopihwa nachiremba wenyu ari kurapa.