FDA 扩展批准一个取代心脏瓣膜, 在世界中被批准的最小机械瓣膜

2018年3月6日美国食品和药品监管局今天扩展一个心脏瓣膜的批准包括一个大小足以在新生而患者中使用以治疗心脏缺陷。特别地, 监管局批准Masters系列机械心脏瓣膜有 血流动力学加(HP) Sewing Cuff以包括15-mm瓣膜大小, 使它在世界上被批准的最小机械心脏瓣膜。

美国FDA的装置和辐射防护中心主任Jeff Shuren, M.D., J.D. 说：“当较大取代心脏瓣膜已被批准共多年, 有一个紧迫需求在幼年儿童患者中, 尤其是新生儿和婴儿, 有先天性瓣膜缺陷，患者可能是太小以使用当前市场心脏瓣膜。”

心脏瓣膜疾病发生如果四个心脏瓣膜中的一个或更多, 瓣膜指引血流通过心脏，瓣膜不能适当地功能，一个功能失常心脏瓣膜是往往导致在出生时先天性心脏缺陷。在美国每年有超过35,000婴儿有先天性心脏缺陷，其中有些将需要心脏瓣膜手术和，潜在地, 取代心脏瓣膜手术。但是, 在今天批准以前, 因为患者大小的小限制获得取代心脏瓣膜。对这些患者Masters系列15-mm HP瓣膜代表一个重要的治疗选择。

Master系列机械性心脏瓣膜是一个可旋转的，双叶瓣[bileaflet](两-散叶)瓣膜被设计为在主动脉或憎帽瓣位移植。双叶瓣设计由两个班圆碟组成，在心跳期间随血压变化而打开和关闭反应与患者自身瓣膜相似。

Masters系列机械性心脏瓣膜在1995年被首次批准为有一个疾病的，受损伤的或功能失常主动脉或二尖瓣心脏瓣膜。这个装置也被批准为在取代以前移植的主动脉或二尖瓣非朊基的[prosthetic]心脏瓣膜。今天的批准扩展了瓣膜大小可得到的范围, 提供较小患者另外的治疗选择。

FDA评价来自一项20例儿童患者单-臂研究的临床数据，患者有严重心衰范围在二尖瓣移植时在年龄从1.5周至27月。数据显示在已知操作后一年, 生存概率为69.3 %而不经受一个瓣膜-相关不良事件的概率为66.8%。在研究经过一年随访观察到严重的瓣膜-相关不良事件，包括在装置中血凝固和在脑中出血。在操作后抗凝(血液稀薄)治疗可能是需要,预防在装置上凝固, 它可能增加出血的风险。.

Master系列机械性心脏瓣膜不应被不能耐受抗凝治疗患者使用。

FDA授权Master系列心脏瓣膜的批准给予St. Jude Medical公司。

§ Sewing cuff redesigned to facilitate supra-annular placement, allowing for an increase in orifice size for a given tissue annulus diameter

§ Increased effective orifice area (EOA), lower pressure gradients, and improved performance1-5

§ 85 degree leaflet opening angle offers improved laminar flow and reduces turbulence1,2,6

§ Controlled torque rotation mechanism allows for easy rotation and intraoperative adjustment

§ The FlexCuff™ is flanged and more pliable than the standard cuff

§ St. Jude Medical heart valves are MR conditional7

Contents: Aortic Valve (1 unit per box)

1. King, M, David T, Fisher J. An initial parametric study on fluid flow through bileaflet mechanical heart valves using computational fluid dynamics. J Eng Med 1994: 208:63-72.

2. Feng Z, Nakamura T, Fujimoto T, et al. In vitro investigation of opening behavior and hydrodynamics of bileaflet valves in the mitral position. Artificial Organs 2002;26(1):32-9.

3. Shipkowitz T, Ambrus J, Kurk J, et al. Evaluation technique for bileaflet mechanical valves. J Heart Valve Dis. 2002, Mar; 11 (2):275-82.

4. St. Jude Medical MRI Safety Document.

5. Walker DK, Brendzel AM, Scotten LN. The New St. Jude Medical Regent mechanical heart valve: Laboratory measurements of hydrodynamic performance. J Heart Valve Dis. 1999;8(6):687-96.

6. Vitale N, Caldarera I, Muneretto C, et al. Italian multicenter study group for the St. Jude Medical Hemodynamic Plus aortic valve prosthesis. Clinical evaluation of St. Jude Medical Hemodynamic Plus versus standard aortic valve prostheses: The Italian multicenter, prospective, randomized study. J Thorac Cardiovasc Surg. 2001;122(4):691-8.

7. Carrel T, Zingg U, Jenni R, et al. Early in vivo experience with the Hemodynamic Plus St. Jude Medical heart valves in patients with narrowed aortic annulus. Ann Thorac Surg. 1996;61(5):1418-22.

8. Ismeno G, Renzulli A, De Feo M, et al. Standard versus Hemodynamic Plus 19-mm St. Jude Medical aortic valves. J Thorac Cardiovasc Surg. 2001;121(4):723-8.

Rx Only

St. Jude Medical prosthetic heart valves are indicated for use as replacement valves in patients with a diseased, damaged, or malfunctioning native or prosthetic valve. Possible side effects for all valvular implants include, but are not limited to: regurgitation, thromboembolic phenomena, resistance to flow, infection, hemolysis, dysrhythmias, and prosthetic dehiscence or failure. Anticoagulation is recommended for patients with mechanical valve implants. Please see the physician’s manual for a full description of indications, contraindications, side effects, precautions, warnings and instructions for use.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. 

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100033292 – May 2012