ʻO ka mea maʻi he wahine 74 makahiki i hoʻopaʻa ʻia i ka haukapila no ka hoʻomau ʻana o ka naʻau hema hema, a me ka fibrillation atrial mau loa, hypertension, diabetes a me nā maʻi olakino ʻē aʻe. Ua holo mālie ka hana me ke kūlana kūpono a me ka hopena ma hope o ke kaʻina hana. Hoʻopau koke ʻia ka mitral valve regurgitation ma hope o ke kaʻina hana me ka ʻole o ka LVOT obstruction. Ua hoʻōla maikaʻi ʻia ka mea maʻi, a ua hoʻoneʻe ʻia mai ka hale mālama kino (ICU) i kahi hale mālama maʻamau i ka lā aʻe me ka hana maʻamau o ka naʻau. Ua hoʻokuʻu ʻia ʻo ia mai ka haukapila ma Dekemaba 30, 2021. Ua hoʻokumu kēia kaʻina kūleʻa i kumu paʻa no nā hihia lapaʻau e hiki mai ana o ka ʻōnaehana HighLife TSMVR o Peijia ma Kina.
"ʻO ka hoʻolālā kūʻokoʻa 'Valve-in-Ring' kūpono ia no ka nui o ka anatomy valve mitral." wahi a Polofesa Mao Chen. “ʻAʻole pono ka hapa nui o nā mea maʻi i ka pani ʻana o ka atrial septal defect ma hope o ka hoʻopaʻa ʻana i ka transseptal me ka catheter hāʻawi 30F, a ʻoi aku ka haʻahaʻa o ka pilikia o ka vascular complications. Hana ʻia ke kaʻina hana ma lalo o ka DSA maʻamau i hui pū me ka echocardiogram, e hāpai i ka hoʻokomo ʻana i kēia ʻenehana. Manaʻo wau e hiki ke hoʻohana ʻia kēia ʻenehana i nā hoʻohana lapaʻau hou aku i ka wā e hiki mai ana e pōmaikaʻi i nā poʻe maʻi me ka regurgitation mitral.
Hāʻawi ka ʻenehana HighLife i nā hiʻohiʻona kūʻokoʻa no ka mālama ʻana i ka lawa ʻole o ka valve mitral
ʻO ka Transcatheter Mitral Valve Replacement ("TMVR") ke hele nei i ke ʻano o ka lapaʻau interventional o ka maʻi puʻuwai. Ua hōʻoia nā haʻawina ʻimi mua i ka palekana a me ka pono o kēia ʻenehana. Ua kūpono ʻo TMVR no nā ʻano anatomical ākea o ka regurgitation mitral (“MR”). Hiki iā ia ke hōʻemi a hoʻopau paha i ka regurgitation a ʻo nā hopena maʻi e hoʻomau mau. Eia kekahi, ʻoi aku ka liʻiliʻi o ka TMVR a hiki ke hana ʻia ma luna o nā poʻe maʻi a i ʻole nā maʻi koʻikoʻi ke hoʻohālikelike ʻia me ka hoʻololi ʻana.
Eia nō naʻe, ke kū nei ke kahua o ka Mitral Valve Replacement i nā pilikia ʻenehana he nui, me ke komo ʻana i ka pūnaewele i manaʻo ʻia, heleuma a me ka pilikia o ka paravalvular leakage ("PVL") a me LVOT obstruction. ʻO ka hapa nui o nā ala e kū nei he transapical a i ʻole heleuma me ka hoʻohana ʻana i ka ikaika radial. Hiki i ka Transapical TMVR ke alakaʻi i ka nāwaliwali o ka ʻiʻo o ka paia ventricular hema a i ʻole ka paʻamau i ka hahau ʻana i ka ventricular hema ma muli o ka ʻoki ʻoki ʻana. ʻO ka heleuma ʻana o TMVR me ka ikaika radial hiki ke hopena i ka nui o ka valve nui a me ka paʻakikī i ka lawe ʻana, hiki ke alakaʻi i ka hoʻololi hou ʻana o ka ventricular hema. Hoʻohana ka ʻōnaehana HighLife TSMVR i kahi manaʻo kūʻokoʻa "Valve-in-Ring" i hiki ke hoʻokō maikaʻi i kēia mau pilikia. Hoʻokaʻawale kēia ʻōnaehana i ka valve mai kona apo heleuma a hāʻawi i nā ʻāpana ʻelua ma o ke aʻa femoral a me ke aʻa femoral.
He kaʻina hana maʻalahi ʻekolu. ʻO ka mua, hoʻonoho ʻia kahi puka uea alakaʻi a puni nā lau a me nā chordae o ka mea maʻi. ʻO ka lua, ua hoʻokomo ʻia ke apo heleuma. ʻO ka hope loa, ua hoʻokuʻu ʻia ka valve pericardial bovine hoʻonui ponoʻī ma o ke komo transseptal. Hoʻopaʻa ʻia ka valve i hāʻawi ʻia e ka launa ʻana a hiki i kahi kūlana equilibrium me ke apo i hoʻonohonoho mua ʻia. ʻO kēia ka mea e hiki ai i ka valve ke noho i kahi kūlana paʻa me kaʻole e hōʻino i kaʻiʻo kumu. He mea maʻalahi ke kaʻina hana e like me ka hoʻonohonoho pono ʻana o ka ʻōnaehana a me ka hoʻonohonoho ponoʻī. ʻO ka hoʻolālā o ka ʻōnaehana kōkua e hoʻēmi i ka pilikia o ka leaka paravalvular a hoʻemi pono i ka nui o ka catheter. Hiki ke hoʻopau maikaʻi ʻia ke kaʻina hana me ke kākoʻo teleproctoring.
Ua hōʻike ʻo Peijia Medical i kona hiki ke hana i ka hui honua a me ka ʻike loea
I Dekemaba 2020, ua komo ʻo Peijia Medical i kahi ʻaelike laikini me HighLife SAS, kahi hui lāʻau lapaʻau e pili ana i Farani, e like me ka HighLife SAS i hāʻawi iā Peijia Medical i laikini kūʻokoʻa e hoʻomohala, hana a kūʻai aku i kekahi mau huahana TMVR proprietary ma ka ʻāina ʻo Greater China. Ua hoʻopau ʻia kēia hoʻololi ʻenehana i ka hapaha ʻekolu o 2021. Ua hoʻokumu ʻia ka hana kūloko me nā kūlana kiʻekiʻe ma Kina: ʻo ka polokalamu HighLife i hana ʻia e Peijia Medical ua hala i nā hoʻokolohua hana āpau e hōʻike ana i ka like me HighLife SAS. Mai ka hoʻomaka ʻana o ka hoʻololi ʻana i ka ʻenehana a hiki i ka hoʻokomo mua ʻana i ka hoʻokolohua lapaʻau noiʻi ma Kina, ua lawe ʻo Peijia Medical ma lalo o hoʻokahi makahiki e hoʻopau i ke kaʻina hana i hōʻike i kona hiki i ka hui honua a me ka ʻike loea.
No ka hoʻonui ʻana i ka hoʻohana ʻana i kēia ʻenehana alakaʻi honua no nā pono o nā maʻi MR ma Kina, ua hana pū nā mea aʻoaʻo Peijia Medical, Professor Nicolo Piazza a me Professor Jean Buithieu mai McGill University Medical Center ma Kanada, a ua hana pū nā loea loea mai HighLife SAS me Peijia. Lapaʻau no ka hoʻomākaukau ʻana no kēia hoʻokolohua lapaʻau. Ua alakaʻi ʻia kekahi mau kau hoʻomaʻamaʻa e pili ana i nā hāmeʻa a me ka hoʻomaʻamaʻa lapaʻau a ua komo pū kekahi Cardiologists ma Kina i ke kaʻina hana e hōʻoia ai i ka hoʻokomo ʻana.
Ua noʻonoʻo nui ʻo Kauka Nicolo Piazza i kēia hui pū ʻana a me ka hoʻokomo maikaʻi ʻana. “ʻOliʻoli loa wau a mahalo hoʻi i ke kākoʻo ʻana iā Polofesa Mao Chen a me kāna hui e hoʻokō i ke kaʻina hana HighLife TSMVR a kaʻana like i koʻu ʻike loea. Pīhoihoi nō hoʻi au i ka ʻenehana maikaʻi loa a me ka launa pū ʻana o Profesor Mao Chen a me ka hui. Hauʻoli nui wau no ka hoʻokomo ʻana i ka ʻōnaehana TSMVR mua ma Asia. Manaʻo wau e hiki i ka HighLife TSMVR pūnaewele ke hoʻopōmaikaʻi i nā mea maʻi i ka wā e hiki mai ana, a ke kakali nei au i ka hoʻomohala ʻoi aku ka ikaika ma ke kahua o ka mitral valve interventional therapy.
ʻO ka mālama ʻana i kāna ʻike ʻo "Devotion to the Heart, Reverence for Life", ʻo Peijia Medical e hoʻoikaika e hoʻomaikaʻi i ka maikaʻi o ke ola o nā maʻi ma o ka ʻimi ʻenehana a me ka hoʻomau ʻana. "Ua ʻike mākou i nā noiʻi hou aʻe e pili ana i ka ʻenehana TMVR i nā pilikia e puka mai ana mai ka anatomy paʻakikī o ka valve mitral a me ka paʻakikī o ka maʻi. Hōʻike kēia mau hana hoʻomau i ke koʻikoʻi o ka lāʻau lapaʻau TMVR, "wahi a Kauka Michael Zhang Yi, Luna Hoʻokele a me Luna Nui o Peijia Medical. "ʻOiai ʻo ke ala transseptal kahi ala i makemake nui ʻia a ʻoi aku ka maikaʻi ma nā ʻano he nui, ʻo ka hapa nui o nā ʻenehana TMVR i kēia manawa ke hoʻohana nei i kahi ala transapical. He alakaʻi alakaʻi honua ʻo HighLife SAS i ka ʻenehana TSMVR, me nā hopena hoʻokolohua lapaʻau hoʻohiki i paʻi ʻia ma TCT 2021 a me PCR London Valves 2021. Mahalo iā Polofesa Mao Chen a me Polofesa Nicolo Piazza no kā lāua hui ʻana i ka implantation mua o ka Peijia's HighLife System, ka implantation kūleʻa. ua hoʻoikaika hou i ko mākou hilinaʻi i ka mālama ʻana i nā maʻi valve mitral me ka ʻenehana interventional invasive maoli. E hoʻomau ka lāʻau lapaʻau ʻo Peijia i kā mākou hoʻolaʻa ʻana i ka hana hou, me ka manaʻolana e hiki i nā poʻe maʻi Kina ke loaʻa i ka maʻi valve mitral ke pōmaikaʻi mai ia mau holomua ʻenehana.
ʻO ka ʻōnaehana HighLife TSMVR o Peijia e hōʻike ana i ke ʻano o ka mitral valve interventional therapy, kahi e hoʻomaikaʻi nui ai i ka maikaʻi o ke ola o nā poʻe maʻi Kina me ka MR koʻikoʻi. ʻAʻole i loli ka manaʻo o Peijia Medical "e kau i ke ola o ka poʻe maʻi a me ka palekana ma o ka hoʻomohala ʻana i nā lāʻau lapaʻau invasive liʻiliʻi ma ka home a ma waho".
He aha e lawe ʻia mai kēia ʻatikala:
- 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.
