COLUMBIA, Md.,Dec. 22, 2020/PRNewswire/ -- ACell, Inc., a leading regenerative medicine company, announced today that it has received CE mark approval for its MicroMatrix®, Cytal® Wound Matrix, and Cytal® Burn Matrix devices. This regulatory approval allows ACell to distribute these products throughout the 27 countries of the European Union.
President and CEOPatrick McBrayersaid, "The CE Mark approval is a significant accomplishment for ACell, which required rigorous regulatory review against stringent safety and clinical standards. We are proud to be one step further to offering our wound management products to patients and their health care providers throughoutEurope."
About Cytal Wound Matrix and MicroMatrix
MicroMatrix, Cytal Wound Matrix, and Cytal Burn Matrix have received CE Mark approval according to the Medical Device Directive and are intended for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-mohs surgery, post-laser surgery podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. These devices are intended for one-time use.
About ACell, Inc.
ACell, Inc. is a leading regenerative medicine company focused on the development, manufacture and sale of products primarily used in acute care settings as part of the treatment and management of moderate to severe wounds and reinforcement of soft tissue surgical defects. ACell's products utilize its proprietary porcine urinary bladder matrix platform technology to facilitate remodeling of site-appropriate tissue.
SOURCE ACell, Inc. Related Links
http://www.acell.com
馬里蘭州哥倫比亞,2020年12月22日/美通社/--領先的再生醫學公司ACell,Inc.今天宣佈,其MicroMatrix®、Cytal®Wound Matrix和Cytal®Burn Matrix設備已獲得CE標誌批准。這一監管批准允許ACell在歐盟27個國家分銷這些產品。
總裁兼首席執行官帕特里克·麥克佈雷耶説:“CE Mark的批准是ACell的一項重大成就,ACell要求嚴格的安全和臨牀標準進行嚴格的監管審查。我們很自豪能在向全歐洲的患者和他們的醫療保健提供者提供我們的傷口管理產品方面又向前邁進一步。”
關於細胞創傷矩陣和微矩陣
MicroMatrix、Cytal Wound Matrix和Cytal Burn Matrix已根據醫療器械指令獲得CE標誌批准,用於治療創傷,包括部分和全部傷口、壓瘡、靜脈潰瘍、糖尿病潰瘍、慢性隧道/破壞傷口、外科傷口(供體部位/移植物、Mohs手術後、激光手術後足部傷口、傷口裂開)、創傷傷口(擦傷、撕裂、二級燒傷、皮膚撕裂)和引流。這些設備僅供一次性使用。
關於ACell公司
ACell公司是一家領先的再生醫學公司,專注於主要用於急性護理環境的產品的開發、製造和銷售,作為治療和管理中、重度傷口和加強軟組織外科缺損的一部分。ACell的產品利用其專有的豬膀胱基質平台技術,促進適當部位組織的重塑。
來源:ACell,Inc.相關鏈接
Http://www.acell.com