Nyowani Implant yeCartilage uye Osteochondral Defects

A BATA FreeRelease 8 | eTurboNews | eTN
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rakanyorwa Linda Hohnholz

CartiHeal Ltd nhasi yazivisa kuti iyo US Chikafu neDrug Administration (FDA) yakapa Premarket Approval (PMA) kune yayo Agili-C™ kudyara.         

Kudyara kunoratidzwa kurapwa kweInternational Cartilage Repair Society (ICRS) giredhi rechitatu kana pamusoro pemabvi-joint surface lesion(s), ine nzvimbo inorapika inokwana 1-7cm2, isina yakanyanya osteoarthritis (Kellgren-Lawrence giredhi 0-3. )

PMA mvumo yakapihwa zvichibva pamhedzisiro yemakore maviri IDE yakakosha yekiriniki yekudzidza. Chidzidzo chacho chakasimbisa hukuru hweAgili-C ™ kudyara pamusoro pezvino Surgical Standard of Care (SSOC) - microfracture uye debridement, kuitira kurapwa kwemabvi akabatanidzwa maronda epamusoro, chondral uye osteochondral defects. Chidzidzo chacho chaive chakawanda, 2: 1 randomization, yakavhurika-yakanyorwa uye yakadzorwa. Zvidzidzo zve251 zvakanyoreswa, 167 muAgili-C™ ruoko, uye 84 muSSOC ruoko, munzvimbo dze26 mukati nekunze kweUS.

Mhedziso yekutanga yekudzidza yaive shanduko kubva kukutanga kusvika kumwedzi ye24 muvhareji yekukuvara kweKnee uye Osteoarthritis Outcome Score (KOOS Overall), iyo inosanganisira 5 subscales: Marwadzo, Zvimwe Zviratidzo, Hupenyu Hwehupenyu (QOL), Mabasa eZuva Kurarama. (ADL) uye Mitambo. Iyo KOOS Overall Score inotangira pa0 kusvika pa100, uko ukoshi hwepamusoro hunomiririra zvirinani.

Iyo data yakagadzirwa kubva muyedzo yakaratidza hukuru hweAgili-C™ kune yazvino yekuvhiya mwero wekutarisira (kubvisa kana microfracture, SSOC). Iyo Bayesian posterior mukana wehukuru mushure memwedzi ye24 yakatemwa kuve 1.000, ichipfuura iyo yakatemwa chikumbaridzo che0.98 inodiwa kuratidza hukuru.

• Yekutanga KOOS Zvibodzwa zvakazara zvakafanana mumapoka maviri: 41.2 muAgili-C™ ruoko uye 41.7 muSSOC ruoko. PaMwedzi 24, iyo KOOS Yese yakagadziridzwa kusvika 84.3 muAgili-C™ ruoko zvichienzaniswa ne62.0 yeruoko rweSSOC.

• Dhigirii yekuvandudzwa kweAgili-C™ kana ichienzaniswa neSSOC yakanga yakafanana kune zvidzidzo zvine Mild-moderate Osteoarthritis (Kellgren-Lawrence Grades ye2 kana 3) uye kune zvidzidzo zvine Large Lesions (nzvimbo dzose dzemaronda dzakakura kudarika 3 cm2).

• Kukwirira kweAgili-C™ kudyara pamusoro peSSOC kwakasimbiswa zvakare mune zvese zvechipiri zvechidzidzo chekupedzisira Confirmatory Endpoints: KOOS Pain, KOOS ADL neKOOS QOL uye Responder Rate.

• Chiyero chekupindura, icho chakanga chiri-priori chakatsanangurwa sekuvandudzwa kwezvinenge 30 points muOverall KOOS pamwedzi 24 zvichienzaniswa nekutanga, yaiva 77.8% muAgili-C™ ruoko kana ichienzaniswa ne33.6% muSSOC ruoko.

"Zvidzidzo zvemakore maviri, izvo zvakaratidza hukuru hweAgili-C ™ kudyara pamusoro peyazvino chiyero chekuvhiya, inopa rubatsiro rwakakosha kumamiriyoni evarwere," akadaro Nir Altschuler, muvambi uye CEO weCartiHeal. "Kubudirira uku kwakagoneka nekuda kwerutsigiro rwevanachipangamazano vedu, Hogan Lovells, vanachipangamazano vedu vezvenhamba, Biomedical Statistical Consulting, uye vazhinji vakazvipira vaongorori nevarwere vakapinda muzvidzidzo zvedu. Tinotenda nerubatsiro rwavo rwese. Mvumo yeFDA inotigonesa kutanga kushambadzira uye kupa mhinduro yepamusoro kune varwere kana ichienzaniswa neyazvino chiyero chesarudzo.

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Avatar of Linda Hohnholz

Linda Hohnholz

Editor mukuru we eTurboNews yakavakirwa muTN HQ.

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