mankhwala

Viveve, Inc., kampani yothandizira ya Viveve Medical, Inc., ndi kampani yathanzi yazimayi yomwe ili ku Englewood, Colorado. Viveve akudzipereka kupititsa patsogolo njira zatsopano zothetsera thanzi la amayi komanso moyo wawo. Kampaniyo ikuyang'ana kwambiri kugulitsa kwamankhwala osinthira, osachita opareshoni, osachotsa opaleshoni omwe amakonzanso collagen ndikubwezeretsanso minofu yamaliseche. Viveve® System yovomerezeka yapadziko lonse imaphatikizira ukadaulo wa Cryogen-utakhazikika wa Monopolar Radiofrequency (CMRF) kuti uperekenso magetsi otenthetsera pang'onopang'ono kwinaku mukuziziritsa minofu yapadziko lapansi kuti ipange neocollagenesis nthawi imodzi muofesi. Ku United States, Viveve System imakonzedwa ndi Food and Drug Administration (FDA) kuti igwiritsidwe ntchito pochita opaleshoni yamagetsi ndi hemostasis. Kuvomerezeka ndi kulandilidwa kwapadziko lonse lapansi kwalandiridwa chifukwa chakulekerera kumaliseche komanso / kapena kusintha kwa ziwonetsero zogonana m'maiko opitilira 50.

Viveve ikupitilizabe kupititsa patsogolo ntchito yake yachitetezo chazachipatala popsinjika kwamikodzo (SUI). Monga tafotokozera mu Disembala 2020, FDA idavomereza zosintha pamayeso ofunikira a US PURSUIT cholinga chake ndikulimbitsa kafukufukuyu komanso kuthekera kwake kukwaniritsa cholinga chake choyambirira. Kusintha kwamaphunziro kuphatikiza kuwonjezeka kwa kukula kwa mayesowo komanso njira zowasankhira odwala ndizotsatira za chitsogozo kuchokera ku Viveve's Clinical Advisory Board pakuwunika zotsatira zabwino kuchokera ku kuthekera kwa kampani ya SUI ndi maphunziro ake asanachitike. Viveve idalandira kuvomerezedwa kwa FDA ndi pulogalamu yake ya Investigational Device Exemption (IDE) kuti ichititse mayesero ochulukirapo, osasinthika, akhungu awiri, oyeserera a PURSUIT pakuwongolera kwa SUI mwa azimayi mu Julayi 2020 ndi kuvomerezedwa ndi FDA pazosintha zomwe apempha pamalamulo a IDE monga adalengeza pa Disembala 10, 2020. Kuyamba kuzenga mlandu kunanenedwa pa Januware 21, 2021 ndipo kulembetsa mitu kuli mkati. Ngati zili zabwino, zotsatira za kuyesa kwa PURSUIT zitha kuthandizira chiwonetsero chatsopano cha US ku US

Mu TH Viveve System imapereka chithandizo chimodzi chokha kuti apange collagen ndikubwezeretsanso minofu. Mawonekedwe apawiri a VIVEVE CHATINGO CHOZIMA NDIPONSO AMATETEZA MADALITSO POTENTHA MTIMA WAKUYA. Chithandizo cha Viveve ndichabwino komanso chothandiza.

ZINTHU ZOSAVUTA ZOLIMBITSA zimalimbitsa minofu ya m'chiuno ndikukhazika pansi minofu ya detrusor pogwiritsa ntchito chiphaso chovomerezeka chokhala ndi chidwi chotsika kwambiri komanso chotsitsimula chothandizira kukodza kwamikodzo ndi zimbudzi. Pezani ndi chida chotsukidwa ndi FDA.