男女羞羞视频在线观看,国产精品黄色免费,麻豆91在线视频,美女被羞羞免费软件下载,国产的一级片,亚洲熟色妇,天天操夜夜摸,一区二区三区在线电影

Medtronic enlists Yale to review bone graft trials

Updated: 2011-08-04 10:59

(Agencies)

  Comments() Print Mail Large Medium  Small 分享按鈕 0

NEW YORK?- Medtronic Inc is funding two independent reviews of studies of its Infuse bone graft in the wake of criticism of the clinical trials it conducted to support the device.

The world's largest medical device company said Wednesday it will provide a $2.5 million grant that will allow Yale University to conduct two independent reviews of the safety and effectiveness of Infuse, which has been on the market since 2002. Medtronic said it will provide Yale with all of the data from the clinical trials it sponsored, and all the side effect reports provided to the Food and Drug Administration.

The Minneapolis company will not participate in the reviews, which are expected to take about six months. They will be available within a year and a half. Medtronic said it will also make all of the Infuse clinical trial data available on ClinicalTrials.gov, and it will help Yale make the data available to researchers through an online registry.

Eugene Carragee, editor in chief of The Spine Journal, which has published articles critical of the company's studies, said that Infuse can be useful for some patients. But he added that "we do not have an accurate assessment of safety in 85 to 90 percent of the people receiving the product."

However, the Medtronic-Yale collaboration is good news, he said.

In late May, The Spine Journal published a study that linked Infuse to a condition that can cause infertility in men. A month later, the journal published an article that suggested some researchers who were involved in previous studies of Infuse did not disclose many serious side effects that were observed in patients. The Spine Journal is the official publication of the North American Spine Society.

The Wall Street Journal reported that 15 surgeons who were involved in the research were paid at least $62 million by Medtronic for other work. The Senate Finance Committee is looking into Infuse.

One industry analyst said Medtronic gets about $800 million in annual revenue from Infuse, which is used in spinal, oral, and dental graft procedures. Infuse contains a genetically engineered protein that can stimulate bone growth. It is used as an alternative to procedures like autologous grafting, where bone is taken from elsewhere in the patient's body. Those procedures can cause lasting pain.

In June, Medtronic Chairman and CEO Omar Ishrak said the second Spine Journal article raised questions about the conclusions the researchers reached in their published reports. However he said he backed the data Medtronic submitted to regulators to gain marketing approval for Infuse.

主站蜘蛛池模板: 喜德县| 桃江县| 武平县| 吉隆县| 焉耆| 顺平县| 山阳县| 兰西县| 亳州市| 克什克腾旗| 板桥市| 班玛县| 花垣县| 丘北县| 洪泽县| 宁津县| 农安县| 商水县| 辉南县| 江达县| 衡东县| 磴口县| 迁西县| 丹棱县| 衡水市| 西贡区| 珠海市| 渝中区| 聊城市| 曲水县| 江北区| 稷山县| 泰安市| 沅江市| 连平县| 长宁区| 南木林县| 临沂市| 左权县| 罗江县| 平谷区| 博爱县| 伊金霍洛旗| 攀枝花市| 喀喇沁旗| 惠州市| 石台县| 牡丹江市| 阿克陶县| 玉溪市| 德江县| 郧西县| 宁波市| 和田县| 田阳县| 高青县| 平陆县| 武陟县| 重庆市| 永吉县| 平遥县| 南通市| 金山区| 桦南县| 象州县| 长宁县| 兰考县| 泰州市| 赞皇县| 保定市| 建德市| 汾西县| 商南县| 汽车| 湘西| 平邑县| 武定县| 鄂尔多斯市| 德令哈市| 通海县| 开江县| 昌图县|