imveliso

Viveve, Inc. UViveve uzibophelele ekuqhubeleni phambili nezisombululo ezitsha zokuphucula impilo yabasetyhini kunye nomgangatho wobomi. Inkampani ijolise kuthengiso lwezixhobo zenguqulelo ezingezizo ezokuhlinzwa, ezingafakwanga isisu ezihlaziya i-collagen kunye nokubuyisela izicwili kwilungu lobufazi. Inkqubo yelungelo elilodwa lomenzi weViveve® System ibandakanya itekhnoloji yeCrgengen-cooled Monopolar Radiofrequency (CMRF) ukuhambisa ubushushu bevolumetric ngokulinganayo ngelixa upholisa izicwili zomhlaba ukwenza i-neocollagenesis kwiseshoni enye eseofisini. E-United States, iNkqubo yeViveve icacisiwe lulawulo lwezoKutya noLawulo lweziyobisi (FDA) ukuze isetyenziswe kwinkqubo yotyando ngokubanzi ye-electrocoagulation kunye neheestasis. Ukwamkelwa kwemigaqo kunye nokuvunywa kwamazwe aphesheya kuye kwafunyanwa ngokungakhathali kwilungu lobufazi kunye / okanye ukuphucula ukusebenza kwezesondo kumazwe angaphezu kwama-50.

IViveve iyaqhubeka nokuqhubela phambili inkqubo yayo yophuhliso lweklinikhi kuxinzelelo lokungahambi kakuhle komchamo (i-SUI). Njengoko kuxeliwe ngo-Disemba ka-2020, i-FDA yamkela utshintsho kwi-US ebalulekileyo ye-PURSUIT yeprothokholi yovavanyo yenzelwe ukomeleza uphononongo ngokubanzi kunye namandla alo okufezekisa ukusebenza kwayo kwasekuqaleni. Utshintsho kufundo kubandakanya ukonyuka kobungakanani betyala kunye neendlela ezingqongqo zokukhetha isigulana ziziphumo zesikhokelo esivela kwiBhodi yeeNgcebiso ngeKlinikhi yaseViveve kuphononongo lweziphumo ezilungileyo ezivela kwiNkampani ye-SUI kunye nezifundo zangaphambi kokuba kwenziwe. UViveve ufumene imvume ye-FDA yesicelo sayo soPhando ngeziXhobo zoPhando (i-IDE) sokuqhuba i-multicenter, i-randomized, blind-blind, i-sham-controlled control PURSUIT yecala lokuphucula i-SUI kwabasetyhini ngoJulayi 2020 kunye nokuvunywa kwe-FDA kwezilungiso zayo eziceliweyo kumgaqo-nkqubo we-IDE njenge ingxelo ngoDisemba 10, 2020. Ukuqaliswa kwetyala kwaxelwa ngoJanuwari 21, 2021 kwaye ukubhaliswa kwezifundo kuyaqhubeka. Ukuba kulungile, iziphumo ezivela kulingo lwe-PURSUIT zinokuxhasa ukubonakaliswa kwe-SUI entsha e-US

KwiNkqubo yeViveve ihambisa unyango lweseshoni enye ukwenza i-collagen kunye nokubuyisela izicubu. Imo ezimbini ezenziwayo I-VIVEVE YONYANGO LOKUPHATHA NOKUKHUSELA UMPHAKATHI NGENXA YOKUShushuTSHA I-TISSUE. Unyango lweViveve lukhuselekile kwaye luyasebenza.

IMVELISO ZE-INCONTROL zomeleza izihlunu zomgangatho we-pelvic kunye nokuzola umsipha we-detrusor usebenzisa i-electrostimulation enelungelo elilodwa lomenzi kunye namanqanaba aphezulu kunye asezantsi okunyanga ukunyanga ukungangqinelani komchamo kunye nelindle. Ukufumana isixhobo esicocekileyo se-FDA.