I-Cerus Endovascular Ltd., inkampani yamathuluzi ezokwelapha esesiteji esiyimfihlo, imemezele namuhla ukuthi isithole imvume ye-US Food and Drug Administration (FDA) 510(k) yama-micro-catheter ayo angu-027, atholakala ubude obubili, ukwandisa umkhiqizo wawo. iphothifoliyo ehlanganisa iplathifomu ye-FDA esuliwe kakade engu-021 micro-catheter. Inkampani ilindele ukuletha Ukumakwa kwe-CE kwawo womabili osayizi ngaphansi kwe-EU entsha ye-Medical Devices Regulation, ngasekupheleni kwalo nyaka.
Ukukhishwa kwemakethe okulinganiselwe kwe-US kwama-micro-catheter angu-027 kulindeleke ukuthi kuqale engxenyeni yesibili ka-2022, kanye neplathifomu ye-micro-catheter engu-021 ezolandela maduze nje ngemva kwalokho.
“Ukugxila kwethu ekuhlangabezaneni nezidingo zemiphakathi yasemtholampilo kanye nodokotela, okuhlanganisa ochwepheshe be-radiologist abangenelelayo, abanemikhiqizo efika ngesikhathi, enenani elikhulu, kufakazelwa yilokhu kugunyazwa kwakamuva kwe-FDA kwama-micro-catheter angu-027, okuzoqala ukuthengiswa kwawo maduze nje, kokubili ngaphakathi. nakwamanye amazwe,” kuphawula uDkt. Stephen Griffin, uMongameli we-Cerus Endovascular.
UJeff Sarge, iPhini Likamongameli Wezocwaningo Nentuthuko e-Cerus Endovascular, waphawula, “Umsebenzi wethu wokuthuthukisa ubonise izici eziphakeme zama-micro-catheter ethu, uma uqhathaniswa namadivayisi atholakalayo manje kwezohwebo futhi sibheke phambili ekusetshenzisweni kwawo okusekelwe kabanzi. Okubalulekile, ama-micro-catheter awagcini nje ngokusekela kuphela i-Cerus Endovascular Contour Neurovascular System™ kanye nomndeni we-Neqstent™ wemikhiqizo kodwa futhi angasetshenziswa yinoma imaphi amanye amadivayisi enkampani ahambisana ne-021 kanye ne-027 micro-catheter.
"Imishini yokwelapha yanamuhla ibeka izidingo ezengeziwe ohlelweni lokulethwa, futhi senze isiteji se-micro-catheter esiklanyelwe ukunikeza ukusekelwa okukhethekile nokuzinza lapho siletha lawa madivayisi ngaphakathi kwe-neurovasculature," kuphetha uMnu. Sarge.
I-Cerus Endovascular nayo imemezele namuhla ukuthi yandisa ukunikezwa kosayizi weplathifomu yayo ye-Contour Neurovascular System. Osayizi abasha abengeziwe, abasathuthukiswayo njengamanje (3mm, 18mm kanye no-22mm), bazovumela ukwelashwa kwama-aneurysms afika ku-18mm ububanzi. UDkt. Griffin waphawula, “Lapho begunyazwa, lawa masayizi amakhulu, ikakhulukazi, azohlangabezana nesidingo somtholampilo esingafinyeleli sokwelapha ama-aneurysms amakhulu ngo-80% kunezixazululo zamanje ezitholakalayo ze-endo-saccular. Umsebenzi wethu uqhubeka njengoba bekuhlelile futhi sibheke ngabomvu ukwenza lawa masayizi amasha atholakale kwezohwebo ngokushesha ngangokunokwenzeka.”
I-Cerus Endovascular ibona ngeso lengqondo ikusasa lapho indlela eyenziwe lula ye-endo-saccular yokwelapha i-aneurysms izoba yisixazululo 'sokuhamba', sinciphise kakhulu isidingo sama-artery stents kanye neziphambukisi zokugeleza ezinqubweni eziningi.
"Ukunwetshwa okuqhubekayo kwephothifoliyo yethu kanye nokwanda kokungena ezimakethe kuyizici ezibalulekile zesu lethu eliqhubekayo lokuthengisa," kusho uDkt. Sam Milstein, uSihlalo we-Cerus Endovascular. “Umkhakha wezohwebo wale nkampani usufinyelela ezikhungweni zemitholampilo ezingaphezu kuka-330, emhlabeni jikelele, futhi maduze nje uzonwebela e-Asia futhi wethule eMelika Ephakathi naseNingizimu. Ukubhalisa ocwaningweni lwe-Cerus Endovascular IDE e-United States kuyaqhubeka njengoba kuhleliwe.”
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- “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.
