緹庡浗FDA璁よ瘉棣栦釜鍙敓鐗╁惛鏀惰綆℃敮鏋?/span>
2016-7-8 鏉ユ簮:涓浗鑱氬悎鐗╃綉 鐐瑰嚮嬈?/span>
鍏抽敭璇嶏細(xì)鏀惰綆℃敮鏋?/a> FDA璁よ瘉
緹庡浗椋熷搧鑽墿綆＄悊灞浜?鏈?鏃ユ壒鍑嗕簡(jiǎn)棣栦釜瀹屽叏鍙惛鏀剁殑娌葷枟鍐犵姸鍔ㄨ剦鐤劇梾鏀灦銆傝鏀灦鍚嶄負(fù)Absorb GT1鐢熺墿鍙惛鏀惰綆℃敮鏋剁郴緇?綆縐癆bsorb GT1 BVS)錛屽畠閲婃斁渚濈淮鑾徃鏉ラ檺鍒剁枻鐥曠粍緇囩殑鐢熼暱錛屽茍鍙湪3騫存椂闂村唴閫愭笎琚漢浣撳惛鏀躲?
Absorb GT1 BVS鏄敱鍙敓鐗╅檷瑙ｈ仛鍚堢墿鑱氫箼閱囬吀(鑱氫箼浜ら叝poly(L-lactide)) 鍒舵垚
Absorb GT1 BVS鏄敱鍙敓鐗╅檷瑙ｈ仛鍚堢墿鑱氫箼閱囬吀(鑱氫箼浜ら叝poly(L-lactide)) 鍒舵垚銆傝繖鏄竴縐嶇被浼肩紳綰跨殑鍏朵粬鍙惛鏀跺尰鐢ㄨ澶囨潗鏂欍?
涓鏃︽?zhèn)ｈ呯殑韜綋涓嶅啀闇瑕佹敮鏋惰繘琛屾不鐤楋紝閲囩敤鑱氫箼閱囬吀鍒舵垚鐨勬敮鏋跺彲鐢辮韓浣撻愭笎鍚告敹錛岄櫎浜?涓潪甯稿井灝忕殑閾傞噾鏍囪鐗╀細(xì)宓屽叆鍔ㄨ剦琛綆″(甯姪鍖葷敓璇嗗埆Absorb GT1 BVS鐨勬斁緗綅緗?錛屽熀鏈叾浠栧鏉ョ墿璐ㄤ笉浼?xì)鐣欏瓨鍦ㄦ?zhèn)ｈ呬綋鍐呫?
鏍規(guī)嵁緹庡浗蹇?jī)鑲鸿鐮旂┒鎵(National Heart, Lung, and Blood Institute)緇熻錛屾瘡騫寸編鍥界害鏈?7涓囦漢姝諱簬鍐犲績(jī)鐥呫傚綋琛綆″唴鑳嗗浐閱囩殑鍚噺澧炲姞錛屼細(xì)浣垮緱鍐犵姸鍔ㄨ剦鐙獎(jiǎng)錛屽噺灝戣繘鍏ュ績(jī)鑴忕殑琛娑叉祦閲忥紝榪欐牱灝變細(xì)鍌敓鍐犲績(jī)鐥呫傚彲鑳戒細(xì)鍑虹幇鑳哥棝(蹇?jī)缁炵?銆佸懠鍚告ヤ績(jī)銆佺柌鍔蟲垨鍏朵粬蹇?jī)鑴忕梾鐥囩姸銆?
鍖葷敓緇忓父閲囩敤閲戝睘鏀灦錛岄氳繃鈥滆綆℃垚褰㈡湳鈥濈殑鏂規(guī)硶鏉ユ墿澶у姩鑴夛紝娌葷枟鍐犵姸鍔ㄨ剦鐤劇梾銆傚湪娌葷枟榪囩▼涓紝鏀灦鍐呬細(xì)鐢熸垚鐤ょ棔緇勭粐錛屼嬌寰楀姩鑴夊啀嬈″彉鐙獎(jiǎng)銆備緷緇磋帿鍙告敮鏋惰兘鐭殏鎬ч噴鏀捐嵂鐗╋紝鐗瑰埆鏄湪妞嶅叆鏀灦鍑犱釜鏈堝悗錛屼互闃繪鐤ょ棔緇勭粐鐨勫艦鎴愩?
鈥淔DA瀵笰bsorb GT1 BVS鐨勮璇佷負(fù)鎺ュ彈琛綆℃垚褰㈡湳鐨勫啝蹇?jī)鐥呮?zhèn)ｈ呮彁渚涗簡(jiǎn)鏂扮殑娌葷枟鏂規(guī)鈥斺斿彲閲囩敤鐢熺墿鍚告敹瑁呯疆鑰屼笉鏄案涔呮х殑閲戝睘鏀灦鏉ヨ繘琛屾不鐤椼傗滷DA璁懼鍜屾斁灝勫仴搴蜂腑蹇?jī)琛綆¤澶囬儴涓諱換Bram Zuckerman鍗氬＋璇淬?
鎹?zhèn)夊Q孉bsorb GT1 BVS鏄敱緹庡浗Abbott Vascular鍏徃鐢熶駭銆?
鍏嶈矗澹版槑錛氶儴鍒嗚祫鏂欐潵婧愪簬緗戠粶錛岃漿杞界殑鐩殑鍦ㄤ簬浼犻掓洿澶氫俊鎭強(qiáng)鍒嗕韓錛屽茍涓嶆剰鍛崇潃璧炲悓鍏惰鐐規(guī)垨璇佸疄鍏剁湡瀹炴э紝
涔熶笉鏋勬垚鍏朵粬寤鴻銆備粎鎻愪緵浜ゆ祦騫沖彴錛屼笉涓哄叾鐗堟潈璐熻矗銆傚娑夊強(qiáng)渚墊潈錛岃鑱旂郴鎴戜滑鍙?qiáng)鏃朵慨鏀规垨鍒犻櫎銆?br>閭錛歩nfo@polymer.cn
錛堣矗浠葷紪杈戯細(xì)liu錛?
