I-Cerus Endovascular Ltd., inkampani yezixhobo zonyango eyimfihlo, ibhengeze namhlanje ukuba ifumene i-US Food and Drug Administration (FDA) 510 (k) imvume ye-027 micro-catheters, efumaneka ngobude obubini, ukwandisa imveliso yayo. ipotfoliyo equka i-FDA esele icociwe 021 iqonga micro-catheter. Inkampani ilindele ukungenisa i-CE yokumakisha zombini iisayizi phantsi kwe-EU entsha yoLawulo lweZixhobo zoNyango, ekupheleni kwalo nyaka.
Ukukhutshwa kwemarike elinganiselweyo yase-US ye-027 micro-catheters kulindeleke ukuba iqale kwikota yesibini ka-2022, kunye neqonga le-catheters elingu-021 eliza kulandela kungekudala emva koko.
“Ujoliso lwethu ekuqhubekekeni ukuhlangabezana neemfuno zoluntu lwezonyango kunye noogqirha, kubandakanywa neengcali zongenelelo ngerediyo, ngeemveliso ezifika ngexesha, ezongezelelwe ixabiso, bungqinwa kolu kwamkelwa kwe-FDA yamva nje ye-027 micro-catheters, apho intengiso iya kuqalisa kwakamsinya, zombini ngaphakathi. nakumazwe ngamazwe,” watsho njalo uGqr. Stephen Griffin, uMongameli weCerus Endovascular.
UJeff Sarge, uSekela Mongameli woPhando kunye noPhuhliso eCerus Endovascular, uthe, "Umsebenzi wethu wophuhliso ubonise iimpawu eziphezulu ze-micro-catheters yethu, xa kuthelekiswa nezixhobo ezikhoyo ngoku zorhwebo kwaye sijonge phambili ekusebenziseni kwabo ngokubanzi. Okubalulekileyo, ii-micro-catheters aziphelelanga ekuxhaseni kuphela i-Cerus Endovascular Contour Neurovascular System™ kunye ne-Neqstent™ intsapho yeemveliso kodwa inokusetyenziswa naziphi na ezinye izixhobo zenkampani ezihambelana ne-021 kunye ne-027 micro-catheters.
"Izixhobo zonyango zanamhlanje zibeka iimfuno ezingakumbi kwinkqubo yokuhanjiswa, kwaye siye saqulunqa iqonga le-micro-catheter eyenzelwe ukubonelela ngenkxaso ekhethekileyo kunye nokuzinza xa uhambisa ezi zixhobo ngaphakathi kwe-neurovasculature," uqukumbele uMnu.
I-Cerus Endovascular ikwabhengeze namhlanje ukuba iyakwandisa iminikelo yeqonga layo leContour Neurovascular System. Ubukhulu obutsha obongezelelweyo, okwangoku ekuphuhlisweni (3mm, 18mm kunye ne-22mm), baya kuvumela unyango lwe-aneurysms ukuya kwi-18mm ububanzi. UGqr. Griffin waphawula, "Ekuvunyweni, ezi zikhulu ezinkulu, ngokukodwa, ziya kuhlangabezana nesidingo esingafezekiyo seklinikhi yokunyanga i-aneurysms 80% enkulu kunezo zisombululo ze-endo-saccular ezikhoyo ngoku zorhwebo. Umsebenzi wethu uqhuba njengoko bekucwangcisiwe kwaye sijonge phambili ekwenzeni obu bukhulu butsha bufumaneke kurhwebo ngokukhawuleza. ”
I-Cerus Endovascular inombono wekamva apho indlela ye-endo-saccular eyenziwe lula ngakumbi yokunyanga ii-aneurysms iya kuba sisisombululo 'sokuya', inciphisa ngokubalulekileyo imfuno ye-artery stents kunye ne-flow diverters kwiinkqubo ezininzi.
"Ukwandiswa okuqhubekayo kwepotfoliyo yethu kunye nokunyuka kokungena kweemarike zizinto eziphambili zesicwangciso sethu esiqhubekayo sokuthengisa," kusho uDkt Sam Milstein, uSihlalo weCerus Endovascular. “Indawo yorhwebo yenkampani ngoku inabela kumaziko ezonyango angama-330, kwihlabathi liphela, kwaye kungekudala iza kwanda ukuya e-Asiya kwaye isungulwe kuMbindi noMzantsi Melika. Ukubhaliswa kulingo lwe-Cerus Endovascular IDE eUnited States kuyaqhubeka njengoko bekucwangcisiwe.
INTO ONOKUYITHATHA KWELI NQAKU:
- “Our focus on continually meeting the demands of the clinical and physician communities, including interventional radiologists, with timely, value-added products, is evidenced by this latest FDA approval for the 027 micro-catheters, for which sales will commence shortly, both domestically and internationally,”.
- market release of the 027 micro-catheters is expected to begin in the second quarter of 2022, with the 021 micro-catheters platform to follow shortly thereafter.
- Importantly, the micro-catheters are not limited to supporting just the Cerus Endovascular Contour Neurovascular System™ and Neqstent™ family of products but can also be used by any other company devices which are compatible with 021 and 027 micro-catheters.
