Ua hoʻolaha ʻo Cerus Endovascular Ltd., kahi hui lāʻau lapaʻau kūʻai kūʻokoʻa, i kēia lā ua loaʻa iā ia ka ʻae ʻana o ka US Food and Drug Administration (FDA) 510 (k) no kāna 027 micro-catheters, loaʻa i ʻelua mau lōʻihi, e hoʻonui ana i kāna huahana. waihona e komo pū ana me ka FDA i hoʻomaʻemaʻe mua ʻia 021 micro-catheter platform. Manaʻo ka ʻoihana e waiho no ka CE Marking o nā nui ʻelua ma lalo o ka EU hou Medical Device Regulation, ma hope o kēia makahiki.

Hoʻomaka ka hoʻokuʻu ʻia ʻana o ka mākeke US palena o ka 027 micro-catheters e hoʻomaka i ka hapaha lua o 2022, me ka 021 micro-catheters platform e hahai koke ma hope.

"ʻO kā mākou manaʻo nui i ka hoʻokō mau ʻana i nā koi o nā kaiāulu a me nā kauka lapaʻau, me nā radiologists interventional, me nā huahana i hoʻohui ʻia i ka manawa kūpono, ʻike ʻia e kēia ʻae FDA hou loa no nā micro-catheters 027, kahi e hoʻomaka koke ai ke kūʻai aku, ma ka home. a ma ka honua holoʻokoʻa," wahi a Kauka Stephen Griffin, Pelekikena o Cerus Endovascular.

Ua ʻōlelo ʻo Jeff Sarge, Hope Pelekikena o ka Research & Development ma Cerus Endovascular, "Ua hōʻike kā mākou hana hoʻomohala i nā hiʻohiʻona kiʻekiʻe o kā mākou micro-catheters, i ka hoʻohālikelike ʻana i nā mea kūʻai aku i kēia manawa a ke kakali nei mākou i kā lākou hoʻohana ākea ākea. ʻO ka mea nui, ʻaʻole i kaupalena ʻia nā micro-catheters i ke kākoʻo wale ʻana i ka Cerus Endovascular Contour Neurovascular System ™ a me Neqstent ™ ʻohana o nā huahana akā hiki ke hoʻohana ʻia e nā ʻoihana ʻē aʻe i kūpono me 021 a me 027 micro-catheters.

"ʻO nā mea lapaʻau o kēia lā e koi hou aku i kahi ʻōnaehana hoʻopuka, a ua kūkulu mākou i kahi kahua micro-catheter i hoʻolālā ʻia e hāʻawi i ke kākoʻo kūikawā a me ke kūpaʻa i ka wā e hāʻawi ai i kēia mau mea i loko o ka neurovasculature," i hoʻopau ai ʻo Mr. Sarge.

Ua hoʻolaha pū ʻo Cerus Endovascular i kēia lā e hoʻonui ana i nā makana nui o kāna kahua Contour Neurovascular System. ʻO nā nui hou aʻe, ke kūkulu ʻia nei (3mm, 18mm a me 22mm), e ʻae i ka mālama ʻana i nā aneurysms a hiki i 18mm ke anawaena. Ua ʻōlelo ʻo Dr. Griffin, "Ma ka ʻae ʻia, ʻo kēia mau nui nui, ʻoi aku ka nui, e hoʻokō i kahi pono lapaʻau i kūpono ʻole no ka mālama ʻana i nā aneurysms 80% ʻoi aku ka nui ma mua o nā hopena endo-saccular i kēia manawa. Ke holomua nei kā mākou hana e like me ka mea i hoʻolālā ʻia a ke kakali nei mākou i ka hoʻolako ʻana i kēia mau nui hou i kūʻai ʻia i ka wā hiki. "

Manaʻo ʻo Cerus Endovascular i ka wā e hiki mai ana kahi ʻoi aku ka maʻalahi o ka endo-saccular i ka mālama ʻana i nā aneurysms he hopena 'go-to', e hōʻemi nui ana i ka pono o nā stents aʻa makua a me nā diverters kahe i ka nui o nā kaʻina hana.

"ʻO ka hoʻonui mau ʻana o kā mākou kōpili a me ka piʻi ʻana o ka mākeke ʻo ia nā mea nui o kā mākou hoʻolālā kalepa hoʻomau," wahi a Dr. Sam Milstein, ka luna o Cerus Endovascular. "Ke piʻi nei ka wāwae kālepa o ka ʻoihana ma luna o 330 mau kikowaena lapaʻau, ma ka honua holoʻokoʻa, a e hoʻonui koke ʻia i Asia a hoʻokuʻu ʻia ma Central a me ʻAmelika Hema. Ke hoʻomau nei ka hoʻopaʻa inoa ʻana i ka Cerus Endovascular IDE hoʻokolokolo ma ʻAmelika Hui Pū ʻIa e like me ka mea i hoʻonohonoho ʻia.

He aha e lawe ʻia mai kēia ʻatikala:

“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.