【medical-news】【资讯翻译】FDA: 美敦力CRT-D 适用指征扩至心功能2级患者（NYHA分级）
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http://www.theheart.org/article/1383769.do
FDA: Medtronic CRT-Ds get NYHA 2 HF indication
Minneapolis, MN - The US Food and Drug Administration (FDA) has approved an expanded indication for Medtronic's cardiac resynchronization therapy with implantable cardioverter-defibrillator (CRT-D) devices [1]. The new labeling permits the devices to be used in patients with mildly symptomatic heart failure (NYHA class 2), with a left ventricular ejection fraction (LVEF) of <30%, left bundle branch block (LBBB), and a QRS duration >130 ms.
Data in support of the expanded indication come from the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) and the Resynchronization/Defibrillation for Ambulatory Heart Failure (RAFT) studies.
The approval comes following a December 2011 meeting of a five-member FDA advisory panel, which voted unanimously that Medtronic CRT-Ds were safe for use in patients who meet the criteria specified in the proposed indication. On a second question, addressing efficacy in this group, the vote was split, with three yes votes and two no votes, identical to the vote for the third and final question, which asked whether the benefits in this population exceeded any risks.
The patient group covered in today's approval decision deviates slightly from that debated by advisors last year, reflecting what was for some their sole concern: the QRS cutoff of >120 ms initially proposed by the sponsor. Medtronic's announcement today cites a QRS duration cut point of >130 ms.
Previously, Medtronic CRT-D devices were indicated for the treatment of patients meeting specific criteria, with NYHA class 3 or 4 HF. According to the company, almost 200 000 US patients and 620 000 worldwide are NYHA class 2 patients.
In September 2010, the FDA announced an expanded indication for three CRT-D devices made by Boston Scientific to include patients with milder heart failure and LBBB, as reported by heartwire.
另外，如使用翻译软件翻译，被发现者扣分1-2分
翻译时参照版规http://news.dxy.cn/bbs/topic/8600034
http://www.theheart.org/article/1383769.do
FDA: Medtronic CRT-Ds get NYHA 2 HF indication
Minneapolis, MN - The US Food and Drug Administration (FDA) has approved an expanded indication for Medtronic's cardiac resynchronization therapy with implantable cardioverter-defibrillator (CRT-D) devices [1]. The new labeling permits the devices to be used in patients with mildly symptomatic heart failure (NYHA class 2), with a left ventricular ejection fraction (LVEF) of <30%, left bundle branch block (LBBB), and a QRS duration >130 ms.
Data in support of the expanded indication come from the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) and the Resynchronization/Defibrillation for Ambulatory Heart Failure (RAFT) studies.
The approval comes following a December 2011 meeting of a five-member FDA advisory panel, which voted unanimously that Medtronic CRT-Ds were safe for use in patients who meet the criteria specified in the proposed indication. On a second question, addressing efficacy in this group, the vote was split, with three yes votes and two no votes, identical to the vote for the third and final question, which asked whether the benefits in this population exceeded any risks.
The patient group covered in today's approval decision deviates slightly from that debated by advisors last year, reflecting what was for some their sole concern: the QRS cutoff of >120 ms initially proposed by the sponsor. Medtronic's announcement today cites a QRS duration cut point of >130 ms.
Previously, Medtronic CRT-D devices were indicated for the treatment of patients meeting specific criteria, with NYHA class 3 or 4 HF. According to the company, almost 200 000 US patients and 620 000 worldwide are NYHA class 2 patients.
In September 2010, the FDA announced an expanded indication for three CRT-D devices made by Boston Scientific to include patients with milder heart failure and LBBB, as reported by heartwire.
