{"id":142758,"date":"2017-08-16T08:12:42","date_gmt":"2017-08-16T15:12:42","guid":{"rendered":"http:\/\/old.newsforchinese.com\/v3\/?p=142758"},"modified":"2017-08-16T09:28:48","modified_gmt":"2017-08-16T16:28:48","slug":"%e5%85%a8%e7%90%83%e4%bd%bf%e7%94%a8%e8%83%83%e6%b0%a3%e7%90%83%e6%b8%9b%e8%82%a5%e7%9a%84%e6%82%a3%e8%80%85%e6%9c%89%e8%87%b3%e5%b0%91%e4%ba%94%e4%ba%ba%e6%ad%bb%e4%ba%a1","status":"publish","type":"post","link":"https:\/\/newsforchinese.com\/v3\/2017\/08\/16\/%e5%85%a8%e7%90%83%e4%bd%bf%e7%94%a8%e8%83%83%e6%b0%a3%e7%90%83%e6%b8%9b%e8%82%a5%e7%9a%84%e6%82%a3%e8%80%85%e6%9c%89%e8%87%b3%e5%b0%91%e4%ba%94%e4%ba%ba%e6%ad%bb%e4%ba%a1\/","title":{"rendered":"\u5168\u7403\u4f7f\u7528\u80c3\u6c23\u7403\u6e1b\u80a5\u7684\u60a3\u8005\u6709\u81f3\u5c11\u4e94\u4eba\u6b7b\u4ea1"},"content":{"rendered":"<p>FDA\u8fd1\u671f\u7a31\uff0c\u81f3\u5c11\u6709\u4e94\u4eba\u5728\u541e\u4e0b\u5e6b\u52a9\u6e1b\u80a5\u7684\u6c23\u7403\u5f8c\u4e0d\u4e45\u6b7b\u4ea1\u3002<!--more--><\/p>\n<p>FDA\u8868\u793a\uff0c\u4ed6\u5011\u4e0d\u77e5\u9053\u662f\u9019\u4e9b\u6c23\u7403\u9084\u662f\u690d\u5165\u5b83\u5011\u7684\u624b\u8853\u9020\u6210\u4e86\u9019\u4e9b\u6b7b\u4ea1\uff0c\u4f46\u5b83\u5411\u91ab\u751f\u767c\u51fa\u8b66\u544a\uff0c\u8981\u6c42\u4ed6\u5011\u5bc6\u5207\u76e3\u63a7\u4f7f\u7528\u80c3\u6c23\u7403\u60a3\u8005\u7684\u72c0\u6cc1\u3002<\/p>\n<p>FDA\u5728\u4e00\u4efd\u8072\u660e\u4e2d\u8aaa\uff1a\u300c\u4e94\u8d77\u6b7b\u4ea1\u4e8b\u4ef6\u5747\u986f\u793a\u60a3\u8005\u7684\u6b7b\u4ea1\u767c\u751f\u5728\u690d\u5165\u6c23\u7403\u4e00\u500b\u6708\u6216\u66f4\u5c11\u7684\u6642\u9593\u5167\u3002\u5728\u4e09\u8d77\u4e8b\u4ef6\u4e2d\uff0c\u6b7b\u4ea1\u5728\u6c23\u7403\u653e\u7f6e\u5f8c\u4e00\u5230\u4e09\u5929\u5c31\u767c\u751f\u4e86\u3002\u76ee\u524d\uff0c\u6211\u5011\u4e0d\u77e5\u9053\u60a3\u8005\u6b7b\u4ea1\u7684\u6839\u672c\u539f\u56e0\u6216\u767c\u751f\u7387\uff0c\u6211\u5011\u4e5f\u7121\u6cd5\u80af\u5b9a\u5730\u5c07\u6b7b\u4ea1\u6b78\u56e0\u65bc\u9019\u4e9b\u6c23\u7403\u6216\u690d\u5165\u6c23\u7403\u7684\u624b\u8853\u3002\u300d<\/p>\n<p>\u5176\u4e2d\u4e00\u6b3e\u8a2d\u5099\u662f\u4e00\u7a2e\u53ef\u653e\u5728\u80c3\u88e1\u4e26\u5145\u5165\u9e7d\u6c34\u7684\u6c23\u7403\uff0c\u5b83\u662f\u7531Apollo 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Endo-Surgery\u88fd\u9020\u7684Orbera\u6c23\u7403\u3002\u53e6\u4e00\u6b3e\u8a2d\u5099\u662f\u7531ReShape\u88fd\u9020\u7684\u96d9\u6c23\u7403\u7cfb\u7d71\u3002Apollo\u7a31\u5b83\u5728\u5168\u7403\u5df2\u7d93\u92b7\u552e27.7\u842c\u500b\u6c23\u7403\u3002 Apollo\u8aaa\u5b83\u5411FDA\u5831\u544a\u4e86\u9019\u4e9b\u6b7b\u4ea1\u4e8b\u4ef6\u3002\u8a72\u516c\u53f8\u5728\u4e00\u4efd\u8072\u660e\u4e2d\u8aaa\uff1a\u300c\u81ea\u5f9eOrbera\u57282015\u5e748\u6708\u7372\u5f97FDA\u6279\u51c6\u5f8c\uff0c\u5df2\u7d93\u6709\u56db\u500b\u570b\u5bb6\u4e94\u540d\u4f7f\u7528Orbera\u80c3\u6c23\u7403\u7684\u60a3\u8005\u6b7b\u4ea1\u3002\u300d \u300c\u4f5c\u70ba\u5176Global Product Surveillance\uff08\u5168\u7403\u7522\u54c1\u76e3\u6e2c\uff09\u5c08\u6848\u7684\u5167\u5bb9\uff0cApollo\u4e3b\u52d5\u5411FDA\u5831\u544a\u4e86\u6240\u6709\u4e94\u8d77\u6b7b\u4ea1\u75c5\u4f8b\u3002\u300d FDA\u8aaa\uff0c\u4ed6\u5011\u6b63\u5728\u8abf\u67e5\u53e6\u5916\u5169\u8d77\u6b7b\u4ea1\u4e8b\u4ef6\u3002 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\u300cOrbera\u5168\u7403\u7522\u54c1\u9ad4\u9a57\u6240\u89c0\u5bdf\u5230\u4ee5\u53ca\u4f86\u81ea\u6587\u737b\u7d9c\u8ff0\u7684\u56b4\u91cd\u8ca0\u9762\u4e8b\u4ef6\u5305\u62ec\uff1a\u6f70\u760d\/\u7cdc\u721b\u3001\u6c23\u7403\u6536\u7e2e\/\u9077\u79fb\u3001\u98df\u9053\u7a7f\u5b54\u3001\u5fc3\u81df\u4f75\u767c\u75c7\/\u5fc3\u81df\u505c\u640f\u4ee5\u53ca\u6b7b\u4ea1\uff0c\u4f46\u9019\u4e9b\u4e8b\u4ef6\u5728\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u4e2d\u5747\u6c92\u6709\u88ab\u89c0\u5bdf\u5230\u3002\u300d\u8a72\u516c\u53f8\u5728\u5176\u7db2\u7ad9\u4e0a\u8aaa\u3002 \u80c3\u6c23\u7403\u662f\u5e02\u5834\u4e0a\u6cbb\u7642\u56b4\u91cd\u80a5\u80d6\u7684\u773e\u591a\u8a2d\u5099\u4e4b\u4e00\u3002\u5b83\u5011\u7684\u76ee\u6a19\u662f\u901a\u904e\u586b\u5145\u80c3\u90e8\u3001\u95dc\u9589\u80c3\u90e8\u5206\u5340\u57df\u6216\u751a\u81f3\u901a\u904e\u624b\u8853\u6e1b\u5c11\u80c3\u5bb9\u7a4d\u4f86\u6e1b\u5c11\u4e00\u500b\u4eba\u7684\u98df\u91cf\u3002 \u5e02\u5834\u7684\u9700\u6c42\u5f88\u5927\u3002 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Endo-Surgery\u88fd\u9020\u7684Orbera\u6c23\u7403\u3002\u53e6\u4e00\u6b3e\u8a2d\u5099\u662f\u7531ReShape\u88fd\u9020\u7684\u96d9\u6c23\u7403\u7cfb\u7d71\u3002Apollo\u7a31\u5b83\u5728\u5168\u7403\u5df2\u7d93\u92b7\u552e27.7\u842c\u500b\u6c23\u7403\u3002 Apollo\u8aaa\u5b83\u5411FDA\u5831\u544a\u4e86\u9019\u4e9b\u6b7b\u4ea1\u4e8b\u4ef6\u3002\u8a72\u516c\u53f8\u5728\u4e00\u4efd\u8072\u660e\u4e2d\u8aaa\uff1a\u300c\u81ea\u5f9eOrbera\u57282015\u5e748\u6708\u7372\u5f97FDA\u6279\u51c6\u5f8c\uff0c\u5df2\u7d93\u6709\u56db\u500b\u570b\u5bb6\u4e94\u540d\u4f7f\u7528Orbera\u80c3\u6c23\u7403\u7684\u60a3\u8005\u6b7b\u4ea1\u3002\u300d \u300c\u4f5c\u70ba\u5176Global Product Surveillance\uff08\u5168\u7403\u7522\u54c1\u76e3\u6e2c\uff09\u5c08\u6848\u7684\u5167\u5bb9\uff0cApollo\u4e3b\u52d5\u5411FDA\u5831\u544a\u4e86\u6240\u6709\u4e94\u8d77\u6b7b\u4ea1\u75c5\u4f8b\u3002\u300d FDA\u8aaa\uff0c\u4ed6\u5011\u6b63\u5728\u8abf\u67e5\u53e6\u5916\u5169\u8d77\u6b7b\u4ea1\u4e8b\u4ef6\u3002 FDA\u9084\u8aaa\uff1a\u300c\u672c\u6a5f\u69cb\u9084\u6536\u5230\u540c\u671f\u767c\u751f\u7684\u53e6\u5916\u5169\u8d77\u8207\u6c23\u7403\u6cbb\u7642\u6f5b\u5728\u4f75\u767c\u75c7\u6709\u95dc\u6b7b\u4ea1\u7684\u5831\u544a(\u4e00\u8d77\u662f\u8207Orbera Intragastric Balloon System\u6709\u95dc\u7684\u80c3\u7a7f\u5b54\uff0c\u53e6\u4e00\u8d77\u662f\u8207 ReShape Integrated Dual Balloon System\u6709\u95dc\u7684\u98df\u9053\u7a7f\u5b54)\u3002\u300d Apollo\u8868\u793a\uff1a\u300c\u4e00\u65b9\u9762\uff0c\u6240\u6709\u75c5\u4f8b\u6b7b\u4ea1\u539f\u56e0\u5747\u6c92\u6709\u63d0\u4f9b\u6216\u88ab\u78ba\u5b9a\uff0c\u53e6\u4e00\u65b9\u9762\uff0cAppolo\u4e5f\u6c92\u6709\u6536\u5230\u4f86\u81ea\u4e3b\u6cbb\u91ab\u5e2b\u6216\u91ab\u9662\u7684\u4efb\u4f55\u6e9d\u901a\u6216\u8aaa\u660e\uff0c\u8aaa\u660e\u9019\u4e9b\u6b7b\u4ea1\u662f\u7531Orbera\u8a2d\u5099\u9020\u6210\u7684\u3002\u300d \u300cOrbera\u5168\u7403\u7522\u54c1\u9ad4\u9a57\u6240\u89c0\u5bdf\u5230\u4ee5\u53ca\u4f86\u81ea\u6587\u737b\u7d9c\u8ff0\u7684\u56b4\u91cd\u8ca0\u9762\u4e8b\u4ef6\u5305\u62ec\uff1a\u6f70\u760d\/\u7cdc\u721b\u3001\u6c23\u7403\u6536\u7e2e\/\u9077\u79fb\u3001\u98df\u9053\u7a7f\u5b54\u3001\u5fc3\u81df\u4f75\u767c\u75c7\/\u5fc3\u81df\u505c\u640f\u4ee5\u53ca\u6b7b\u4ea1\uff0c\u4f46\u9019\u4e9b\u4e8b\u4ef6\u5728\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u4e2d\u5747\u6c92\u6709\u88ab\u89c0\u5bdf\u5230\u3002\u300d\u8a72\u516c\u53f8\u5728\u5176\u7db2\u7ad9\u4e0a\u8aaa\u3002 \u80c3\u6c23\u7403\u662f\u5e02\u5834\u4e0a\u6cbb\u7642\u56b4\u91cd\u80a5\u80d6\u7684\u773e\u591a\u8a2d\u5099\u4e4b\u4e00\u3002\u5b83\u5011\u7684\u76ee\u6a19\u662f\u901a\u904e\u586b\u5145\u80c3\u90e8\u3001\u95dc\u9589\u80c3\u90e8\u5206\u5340\u57df\u6216\u751a\u81f3\u901a\u904e\u624b\u8853\u6e1b\u5c11\u80c3\u5bb9\u7a4d\u4f86\u6e1b\u5c11\u4e00\u500b\u4eba\u7684\u98df\u91cf\u3002 \u5e02\u5834\u7684\u9700\u6c42\u5f88\u5927\u3002 \u5118\u7ba1\u73fe\u5728\u6709\u4e00\u4e9b\u80a5\u80d6\u85e5\u7269\u5df2\u7d93\u4e0a\u5e02\uff0c\u4f46\u5b83\u5011\u4e26\u6c92\u6709\u53d6\u5f97\u5de8\u5927\u7684\u5546\u696d\u6210\u529f\u3002\u5e7e\u5e74\u524d\uff0c\u5728\u88ab\u767c\u73fe\u6703\u5c0e\u81f4\u4e2d\u98a8\u7b49\u554f\u984c\u5f8c\uff0c\u4e00\u4e9b\u85e5\u7269\u88ab\u4e0b\u67b6\u3002 \u7bc0\u98df\u5728\u5e6b\u52a9\u4eba\u5011\u9577\u6642\u9593\u4fdd\u6301\u9ad4\u91cd\u4e0a\u4e5f\u540c\u6a23\u6548\u679c\u4e0d\u4f73\u3002\u4f46\u662f\u7e2e\u80c3\u5916\u79d1\u624b\u8853\u662f\u975e\u5e38\u6210\u529f\u7684\u3002\u4e00\u9805\u7814\u7a76\u8868\u660e\uff0c\u7e2e\u80c3\u624b\u8853\u5e6b\u52a9\u4eba\u5011\u6e1b\u8f15\u9ad4\u91cd\u8db3\u4ee5\u9006\u8f492\u578b\u7cd6\u5c3f\u75c5\u3002 American Diabetes Association\uff08\u5168\u7f8e\u7cd6\u5c3f\u75c5\u5354\u6703\uff09\u548c\u5176\u4ed6\u7d44\u7e54\u5df2\u7d93\u8a8d\u53ef\u6e1b\u80a5\u624b\u8853\u4f5c\u70ba\u6cbb\u76422\u578b\u7cd6\u5c3f\u75c5\u7684\u4e00\u7a2e\u65b9\u6cd5\u3002\" 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