Kayayyakin Shiga Tsakanin Zuciya da Jijiyoyin Jiki: Kirkire-kirkire da Nasarorin da ke Sake Fasalta Masana'antar

Gabatarwa: Shiga Tsakanin Zuciya da Jijiyoyi a Zamanin Maganin Daidaito

Cutar zuciya da jijiyoyin jini ta kasance ɗaya daga cikin manyan barazanar kiwon lafiya a duniya. A ƙasar Sin, kimanin mutane miliyan 330 suna fama da cututtukan zuciya da jijiyoyin jini, ciki har da kimanin miliyan 11.39 da ke fama da cutar jijiyoyin jini (CAD). A tsakiyar hanzarta tsufar jama'a da kuma karɓar ra'ayoyin magani marasa rinjaye, kayayyakin rigakafin zuciya da jijiyoyin jini suna ci gaba da bunƙasa a wani mataki da ba a taɓa gani ba. Daga dabarun "barin komai a baya" na balan-balan da aka shafa wa magani zuwa ci gaba a cikin lithotripsy na jijiyoyin jini (IVL), daga amincewa da zuciya ta farko da aka haɓaka a cikin gida zuwa tura robots na tiyata na jijiyoyin jini, jerin abubuwan da suka faru sun nuna cewa maganin rigakafin zuciya da jijiyoyin jini ya shiga wani sabon mataki. A lokaci guda, manufofin saye-saye na tushen girma (VBP) suna ci gaba da sake fasalin yanayin masana'antar, maye gurbin gida yana hanzarta, kuma ɓangaren shiga tsakani na zuciya da jijiyoyin jini yana canzawa daga "wadatar bayanai" zuwa "ƙirƙirar ƙima".

Wannan labarin ya yi bitar sabbin ci gaba a cikin samfuran shiga tsakani na zuciya da jijiyoyin jini a fannoni uku: manyan abubuwan da suka faru kwanan nan, iyakokin kirkire-kirkire na fasaha, da kuma yanayin yanayin masana'antu.

I. Manyan Muhimman Abubuwan Da Suka Faru Kwanan Nan: Abubuwan Da Suka Faru Akai-akai

1. Zuciyar wucin gadi ta shiga tsakani: Amincewa ta farko a cikin gida, Kasuwa mai darajar biliyan ɗari da aka ƙaddamar a hukumance

A watan Disamba na shekarar 2025, zuciyar wucin gadi da kamfanin Shenzhen Core Medical Technology Co., Ltd. ya samar ta sami amincewa daga Hukumar Kayayyakin Lafiya ta Kasa (NMPA), inda ta zama samfurin farko da aka amince da shi a cikin gida. Tsarin yana amfani da fasahar injinan kwararar axial-flow don tallafin ventricular na ɗan gajeren lokaci. A matsayinta na fasaha ta farko a cikin gida, tana cike gibin da ke cikin ɓangaren na'urorin taimakon zuciya na kasar Sin.

Ana amfani da zukata masu wucin gadi a cikin aikin tiyatar zuciya (PCI) da kuma a cikin mawuyacin hali kamar girgizar zuciya. A duk duniya, jerin Impella na Abiomed shine samfurin da aka yi amfani da shi a wannan fanni, tare da aikace-aikacen da aka yi amfani da su sama da 400,000 a duk duniya da kuma kudaden shiga na shekarar kuɗi ta 2025 na biliyan 1.751, wanda ke nuna ƙarfin juriyar ci gaba. Sayen Abiomed na biliyan 16.6 na Johnson & Johnson a shekarar 2022 ya ƙara nuna muhimmancin darajar kasuwanci na wannan fanni.

Abin lura shi ne, baya ga samfurin da Core Medical ta amince da shi, kamfanoni sama da goma na cikin gida suna haɓaka zukatan wucin gadi. Da yawa daga cikinsu sun kammala gwaje-gwajen asibiti ko kuma suna gab da kammalawa, tare da babban yuwuwar samun amincewar NMPA a shekarar 2026. Ana sa ran shekarar 2026 za ta zama "shekarar amincewa ta gama gari" ga zukatan wucin gadi, wanda zai sake fasalin yanayin kasuwa na biliyoyin daloli.

2. Duban dan tayi a cikin jijiyoyin jini: An amince da catheter mai inganci mai girman 60 MHz na gida, wanda aka ƙara sabon kayan aiki don PCI mai daidaito

A ranar 13 ga Maris, 2026, Boston Scientific ta sanar da cewa an amince da na'urar daukar hoton duban dan tayi ta intravascular ultrasound (IVUS) mai suna OptiCross™ HD, kuma za a kera ta a gida a cibiyar samar da Lingang da ke Shanghai. Wannan ya nuna na'urar farko ta likitanci ta Boston Scientific da aka amince da ita a masana'antar kera ta kasar Sin.

OptiCross™ HD shine katifar IVUS mai girman 60 MHz ta farko da aka amince da ita a kasar Sin. Tana amfani da fasahar zamani ta transducer da broadband, tana samar da hoton bidiyo mai girman gaske yayin da take kula da shigar kyallen jiki mai kyau. Tana iya hango tsarin bangon jijiyoyin jini da plaque mai matakai uku, tana taimaka wa likitoci su tantance raunuka daidai da kuma inganta dabarun magani, ta haka ne za a inganta ingancin hanyoyin aiki da kuma sakamakon magani.

Sau da yawa ana kiran IVUS da "ido na uku" na likitocin da ke kula da jijiyoyin zuciya kuma ya zama sabon "ma'aunin zinare" don tantance jijiyoyin zuciya. Duk da haka, ƙimar aikace-aikacen IVUS a yanzu a cikin hanyoyin PCI a China kusan kashi 18% ne kawai, ƙasa da sama da kashi 50% a ƙasashe masu tasowa da kuma kashi 90% a Japan. Tare da samarwa na gida, ana sa ran samun damar amfani da fasahar IVUS mai inganci zai inganta sosai, wanda ke haifar da faɗaɗa amfani da PCI mai daidaito.

A daidai wannan lokacin, na'urar maganin duban dan tayi ta cikin jijiyoyin jini da kuma na'urar duban dan tayi ta cikin jijiyoyin jini da Shanghai MicroPort Rhythm Medical Technology Co., Ltd. ta samar suma sun sami amincewar NMPA. Wannan samfurin yana amfani da fasahar girgiza mitar piezoelectric na lantarki kuma shine tsarin jagora na farko na gida wanda ke amfani da girgizar injiniya don magance raunukan toshewar zuciya (CTO).

3. Takaitaccen Lokacin DAPT don Ciwon Zuciya: HT Supreme™ na Sino Medical ya sami amincewar EU

A ranar 20 ga Mayu, 2026, Sino Medical Sciences Technology Inc. ta sanar da cewa tsarinta na HT Supreme™ drug-eliting stent (DES) ya sami amincewar Tarayyar Turai don DAPT (maganin hana platelet biyu) na ɗan gajeren lokaci kamar wata ɗaya bayan dasawa a cikin jimlar marasa lafiya na CAD. Wannan amincewar ta dogara ne akan binciken asibiti na kamfanin bayan kasuwa, PIONEER IV, wanda aka buga sakamakonsa na wucin gadi a cikin Jaridar Zuciya ta Turai a watan Fabrairun 2026.

Wannan amincewa ta nuna muhimmin mataki na gaba wajen inganta tsarin magunguna bayan an yi amfani da su wajen magance cututtukan zuciya a duniya, wanda ke taimakawa wajen rage haɗarin zubar jini da kuma nauyin tattalin arziki da ke tattare da maganin hana zubar jini na dogon lokaci, yayin da kuma inganta gasa a kasuwar samfurin a Turai da kasuwannin duniya.

4. Sauran Muhimman Amincewa

Tsarin sake gina reshe uku na Concave Supra, wanda Lifetech Scientific da Farfesa Chang Shu na Asibitin Fuwai suka haɓaka tare, ya shiga Tsarin Bita na Musamman na Na'urar Kiwon Lafiya ta NMPA. Wannan samfurin na farko a duniya yana ba da mafita mai haɗaka ba tare da cerebral-ischemia ba don sake gina reshe uku, wanda ya dace da maganin da ba shi da haɗari ga rikitarwar aortic arche aneurysms da ulcers masu shiga cikin sauƙi. Bibiyar watanni goma sha biyu daga nazarin yuwuwar ya nuna kyakkyawan wurin da aka sanya stent a cikin baka na aortic da jijiyoyin reshe, babu endoleak, ƙarfin dukkan jijiyoyin reshe, kuma babu wani mummunan lamari.

Bugu da ƙari, catheter ɗin faɗaɗa balloon na Acotec Scientific (Jingyi) ya sami amincewar yin rijistar NMPA; an amince da amfani da microcatheter na jijiyoyin jini na MicroPort Endovascular (Torqueflex/Linglong Tube) don kasuwa; kuma NMPA ta amince da samfuran kirkire-kirkire da yawa a jere, gami da tsarin bawul ɗin aortic na transcatheter, tsarin yanke bawul na transcatheter mitral, da tsarin rufewa na patent foramen ovale (PFO), wanda ke nuna ci gaba da ƙirƙira mai ƙarfi a ɓangaren shiga tsakani na zuciya.

II. Iyakokin Fasaha na Ƙirƙirar Fasaha: Daga "Bari Komai a Baya" Zuwa Juyin Juya Halin Hankali

1. Lithotripsy na jijiyoyi (IVL): Karya Kulle a Maganin Ciwon Calcified

Raunukan da aka samu a cikin jijiyoyin zuciya (cardiary calcified) sun daɗe suna zama "wahalar fashewa" a lokacin da ake yin maganin sa baki. Baloons sau da yawa ba sa faɗaɗa ƙwayoyin calcified gaba ɗaya, kuma dabarun gargajiya suna fuskantar ƙalubale kamar sarkakiyar hanya da haɗarin rikitarwa mai yawa. IVL ta amfani da ƙa'idar lithotripsy daga urology zuwa ga jijiyoyin jini, tana isar da kuzarin sonic na pulsatile don karya zurfin ma'adinan calcium a cikin intima da media yayin da take rage rauni ga kyallen jiki na yau da kullun.

Tsarin DEEPQUAKE-C na coronary IVL na Grand Pharmaceutical kwanan nan ya sami amincewar NMPA, wanda ya ƙara wa "akwatin kayan aiki" don maganin raunukan da aka yi wa calcified kafin a fara magani da kuma taimakawa wajen shiga cikin wani sabon mataki na "gyaran calcium daidai".

BlueSail Medical kuma tana da matuƙar himma a wannan fanni. Tsarin IVL na Sonicracker™ coronary IVL da aka haɓaka da kanta yana ɗauke da sabbin abubuwa da suka haɗa da kayan balan-balan mai lanƙwasa biyu, catheter mai diamita mai canzawa da yawa, da kuma electrodes na zobe masu kama da juna, waɗanda suka cimma nasarori a cikin juriya ga matsin lamba, bin diddigi, da rarraba matsin lamba. A watan Agusta na 2025, BlueSail Medical ta fara nazarin asibiti na SONICURE, binciken asibiti na farko na duniya wanda ya mayar da hankali kan restenosis na in-stent (ISR). Wannan gwajin da aka yi, mai cibiya da yawa, wanda aka sarrafa bazuwar yana nufin cike gibin shaida mai mahimmanci ga IVL wajen magance ISR mai tsanani da calcification ke haifarwa.

2. Robots na Tiyata na Jijiyoyin Jijiyoyi: Ra'ayoyin Ƙarfi da Hankali

Robot ɗin tiyata suna daga cikin waɗanda ake sa ran za su yi amfani da su wajen magance cututtukan zuciya da jijiyoyin jini. A taron shekara-shekara na Zhongguancun Forum na 2026, Wego Medical ta nuna wani robot na tiyatar zuciya da aka ƙirƙiro a cikin gida, wanda shi ne karo na farko da aka amince da shi don kasuwa a China kuma yana da ikon "ƙarfafa martani". Yana iya tattara ƙarfin hulɗa tsakanin kayan aiki da bangon jijiyoyin jini, yana aika siginar zuwa ga likita ba tare da ɓata lokaci ba, tare da mafi ƙarancin daidaiton ƙarfin da ke tsakanin 0.01 N (kimanin gram 1). Tsarin yana tallafawa aiki daga nesa, yana ba likitoci damar yin aiki ba tare da aprons na gubar ba, wanda hakan ke rage yawan fallasa radiation.

A watan Maris na wannan shekarar, XCath, wani kamfanin robot na shiga tsakani na jijiyoyin jini, ya sanar da kammala zagayen tara kuɗi na dala miliyan 30 (kimanin RMB miliyan 210) na Series C, wanda cibiyar saka hannun jari ta Gabas ta Tsakiya Crescent Enterprises da kuma "uba na robot na tiyata" suka jagoranta. Jimillar kuɗin da aka tara ya kai dala miliyan 92. Babban samfurin kamfanin, tsarin robot na shiga tsakani na jijiyoyin jini na Iris, ya kammala amfani da shi na farko a asibiti a karon farko.

A bikin baje kolin CMEF karo na 93 a watan Afrilu, Kamfanin MicroPort ya baje kolin muhimman kayayyaki a manyan sassa guda biyar, inda ya mayar da hankali kan tiyatar robot, maganin cututtukan zuciya, da kuma maganin cututtukan jijiyoyin jini. A halin yanzu, Rayner Surgical Intelligence ta ƙaddamar da wani robot na tiyatar jijiyoyin jini mai amfani da AI mai sarrafa kansa, wanda ke nuna yanayin haɗin kai mai zurfi tsakanin AI da robot na tiyata.

3. Balloons Masu Rufi da Magunguna da Dabarun "Bari Komai A Baya"

Balan-balan da aka shafa wa magani (DCBs) sun zama muhimmin alkibla wajen shiga tsakani a cikin jijiyoyin zuciya ta hanyar ba da damar yin amfani da dabarun "ba a dasa su ba". Zagaye na shida na VBP na ƙasa (ga DCBs da samfuran samun damar fitsari) ya fara aiki a hukumance a ranar 31 ga Mayu, 2026. Farashin tayin da ya yi nasara ga DCBs ya kama daga RMB 1,677 zuwa RMB 6,015, wanda ya shafi manyan 'yan wasa kamar B. Braun, Boston Scientific, Acotec, Lepu, da Gore. Farashin jerin DCB a da ya fi RMB 20,000. Bayan wannan zagayen VBP, an fayyace farashin kayayyakin da aka saba amfani da su, wanda hakan ya rage nauyin kuɗi ga marasa lafiya sosai.

III. Tsarin Muhalli na Masana'antu da Yanayin Kasuwa: Girman Kasuwa Ya Wuce Naira Biliyan 90 a Matsayin Sauya Tsarin Cikin Gida da VBP Ya Sake Fasalta Yanayin Kasa

1. Faɗaɗa Kasuwa Mai Dorewa

Kasuwar na'urorin rigakafin cututtukan zuciya da jijiyoyin jini ta kasar Sin na fuskantar ci gaba mai sauri. A cewar kididdiga daga Cibiyar Bincike ta Guangdong don Sabbin Kayan Halitta da Na'urorin Lafiya Masu Kyau, karuwar karuwar kowace shekara (CAGR) ta kasuwar na'urorin rigakafin cututtukan zuciya da jijiyoyin jini ta kasar Sin a cikin shekaru biyar da suka gabata ta kai kashi 10.2%, kuma ana sa ran girman kasuwa zai wuce RMB biliyan 90 a shekarar 2026.

A duk duniya, kasuwar kayan aikin tiyatar zuciya da abubuwan amfani tana faɗaɗa sosai. Bayanan bincike da kasuwanni sun nuna cewa ana hasashen kasuwar kayan aikin tiyatar zuciya ta duniya za ta girma daga biliyan 15.65 a shekarar 2025 zuwa biliyan 21.76 nan da shekarar 2030, a CAGR na 7.2%.

2. Saurin Sauya Gida

Duk da saurin karuwar kasuwa, ɓangaren mai girma ya ci gaba da mamaye manyan ƙasashen duniya. Medtronic, Boston Scientific, da sauransu suna riƙe da fiye da kashi 60% na kasuwar na'urorin shiga tsakani na zuciya da jijiyoyin jini masu ƙarfi. Duk da haka, "juyin juya halin farashi" a cikin stents na zuciya da jijiyoyin jini na cikin gida ya kasance abin mamaki - farashin stent ya faɗi daga sama da RMB 10,000 zuwa kusan RMB 700, wanda ya kai kashi 95% na cikin gida a fannin IVUS, kodayake Boston Scientific da Philips sun kasance manyan 'yan wasa biyu, Shenzhen Blinova Medical ta kama kashi 18.02% na kasuwa tare da tallace-tallace kusan RMB miliyan 16, wanda ke nuna karuwar masu fafatawa a cikin gida.

A cikin aikin tiyatar zuciya, na'urorin jagora da na'urorin catheter har yanzu suna fuskantar ƙalubalen ƙarancin canjin aiki a cikin gida. Duk da haka, a fannoni masu ƙarfi kamar ilimin electrophysiology na zuciya da kuma bawuloli na transcatheter, ƙirƙira a cikin gida yana hanzarta. An amince da jimillar na'urorin likitanci guda 76 a cikin 2025, gami da tsarin cirewar ƙwaya da yawa (PFA) waɗanda suka sami amincewa mai yawa.

3. Daidaita VBP da "Anti-Involution"

Kamar yadda ƙwararru a fannin ha2026 ke ɗaukarsa a matsayin "shekarar canza kaya" don VBP mai amfani mai daraja. An aiwatar da zagaye na shida na VBP na ƙasa (DCBs, damar shiga urological), tare da ƙa'idodi da aka tsara musamman don magance "involution" (gasar cikin gida mai yawa) - ba wai kawai zaɓar mafi ƙarancin farashin tayin don ƙididdige bambance-bambancen farashi ba, amma amfani da kashi 65% na matsakaicin farashin nasara a matsayin ma'aunin sarrafa bambancin farashi lokacin da mafi ƙarancin tayin ya yi ƙasa sosai. A halin yanzu, wasu ayyuka da yawa suna ci gaba, gami da haɗin gwiwar masu bugun zuciya na larduna 27 VBP da na waje. Samun Shiga Jijiyoyin Jijiyoyi VBP na microcatheter.

Duk da cewa rage farashin da VBP ta kawo yana haifar da matsin lamba na ɗan gajeren lokaci kan ribar kamfanoni, suna kuma tilasta wa masana'antar ta sauya daga "wanda aka tura ta hanyar tashoshi" zuwa "wanda aka tura ta hanyar kirkire-kirkire", suna ƙarfafa haɓaka saka hannun jari a cikin bincike da ci gaba, ƙimar asibiti mafi girma, da kuma hanzarta kawar da tsoffin iya aiki.

4. Ci gaba da Tsarin Ilimi don Ƙarfafa Masana'antar

A matsayinsu na ƙwararru a fannin A watan Afrilun 2026, an gudanar da taron shekara-shekara na 24 na China Interventional Therapeutics (CIT 2026) a Beijing. Farfesa Gao Runlin ne ya kafa CIT a shekarar 2003, daga mahalarta sama da 890 zuwa ɗaya daga cikin dandamalin ilimi na duniya mafi tasiri don magance cututtukan zuciya a yankin Asiya-Pacific. Manyan dandamali na musayar ilimi kamar CIT suna ba da tallafi mai mahimmanci don tabbatar da asibiti, yaɗa fasaha, da haɗin gwiwar masana'antu a cikin samfuran magance cututtukan zuciya.

Hasashen Duniya: Hanyar da ke Gaba da Sabbin Dabaru ke Jagoranta

Kayayyakin tiyatar zuciya da jijiyoyin jini suna tsaye a farkon sabon canjin fasaha. Fasaha ta zamani kamar su zuciya ta wucin gadi, tsarin IVL, da robots na tiyata suna canzawa cikin sauri daga dakin gwaje-gwaje zuwa asibiti, suna ba marasa lafiya ƙarin zaɓuɓɓukan magani. A halin yanzu, canjin "hana juyin mulki" a cikin manufofin VBP da haɓaka maye gurbin gida suna sake fasalin dabarun gasa na masana'antar. Babban gasa na kamfanoni yana ƙara canzawa daga ikon tashoshi da fa'idodin farashi zuwa cikakken ƙarfin da ke haɗa bambancin fasaha, shaidar asibiti, da damar kasuwa.

A cikin shekaru masu zuwa, kasuwar shiga tsakani ta zuciya da jijiyoyin jini za ta fuskanci manyan sauye-sauye, wanda ke haifar da sabbin fasahohi da kuma jagororin manufofi. Kamfanonin da suka cimma ci gaba mai dorewa a fannin bincike da hanyoyin magance cututtuka, na'urori masu wayo, da kuma sabbin kirkire-kirkire daban-daban za su sami matsayi mai kyau a zagaye na gaba na hadewar masana'antu. Kamar yadda Cibiyar Bincike ta Guangdong ta ba da shawara kan Sabbin Kayan Halitta da Na'urorin Lafiya Masu Kyau, dukkan masana'antar dole ne ta fuskanci matsalolin ci gabanta, ta mayar da hankali kan kokarinta daidai, ta cimma manyan nasarori, da kuma kokarin samun sauyi daga "wadatar bayanai" zuwa "kirkirar darajar kayayyaki".

A ƙarƙashin jagorancin dabarun "Lafiya a China", kayayyakin shiga tsakani na zuciya da jijiyoyin jini za su zama masu sauƙin samu, aminci, da kuma wayo, wanda zai samar da kariya mai ƙarfi ga rayuwa da lafiyar ɗaruruwan miliyoyin marasa lafiya da ke fama da cututtukan zuciya da jijiyoyin jini.

Bayanin Hana Yaɗuwa: Wannan labarin don yaɗa labaran likita ne kawai, kuma ba wai don shawarwarin likita na ƙwararru ba ne. Da fatan za a bi tsarin ganewar asali da magani da likitan da ke kula da ku ya bayar.