EDWARDS INTUITY Elite瓣膜系统旨在同时达到三个重要的目标:


EDWARDS INTUITY Elite瓣膜系统代表了我们对心脏瓣膜治疗外科医生和患者持续创新的承诺。

我们将久经考验的心包瓣膜技术经导管心脏瓣膜的创新技术结合在一起创造了一个新的手术瓣膜类别,以简化程序,方便进行小切口手术。 我们相信,更高效、侵入性更小的手术可以在手术过程中和手术后提供显著的益处。










如多项临床研究所示,EDWARDS INTUITY瓣膜平台1年内始终呈现低的平均压力梯度。

在一项大型前瞻性试验中1,EDWARDS INTUITY Elite瓣膜显示出优异且稳定的血流动力学性能,并且LV质量也明显退化到了3年前的水平。


*这些数据属于上一代的EDWARDS INTUITY瓣膜,是TRITON试验的一部分。



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  1. Haverich A, Wahlers TC, Borger MA, et al. Three-Year Hemodynamic Performance, Left Ventricular Mass Regression, and Prosthetic-Patient-Mismatch After Rapid Deployment Aortic Valve Replacement in 287 Patients, J Throac Cardiovasc Surg. 2014;148(6):2854-60
    **这些数据属于上一代EDWARDS INTUITY系统,并支持EDWARDS INTUITY Elite瓣膜系统的CE Mark认证。
  2. Banbury MK, Cosgrove DM III, White JA, et al. Age and Valve Size Effect on the Long-term Durability of the Carpentier-Edwards Aortic Pericardial Bioprosthesis. Ann Thorac Surg. 2001;72(3):753-757. (队列大小=267,平均年龄=65±12岁。未报告最后一次随访时SVD外植体风险的数量)
  3. McClure RS, Narayanasamy N, Wiegerinck E, et al. Late Outcomes for Aortic Valve Replacement with the Carpentier-Edwards Pericardial Bioprosthesis: Up to 17-year Follow-up in 1,000 Patients. Ann Thorac Surg. 2010;89(5):1410-1416. (队列大小= 1000,平均年龄= 74.1 ± 0.29岁。未报告最后一次随访时SVD风险的数量)
  4. Welke KF, Wu Y, Grunkemeier GL, Ahmad A, Starr A. Long-term results after Carpentier-Edwards pericardial aortic valve implantation, with attention to the impact of age. The Heart Surgery Forum. 2011;14(3):E160-165。
  5. Minakata K, et al. Long-Term Outcome of the Carpentier-Edwards Pericardial Valve in the Aortic Position in Japanese Patients. Circulation Journal 2014;78:882-889。 (队列大小= 574,平均年龄= 71.9岁。15年随访期间的结构恶化风险的数量= 54)
  6. Jamieson WR, Germann E, Aupart MR, et al. 15-year Comparison of Supra-annular Porcine and PERIMOUNT Aortic Bioprostheses. Asian Cardiovasc Thorac Ann. 2006;14(3):200-205. (队列大小= 1430,平均年龄= 69.5± 10.4岁。最后一次随访时SVD风险的数量= 33)
  7. Grunkemeier GL, Furnary AP, Wu Y, Wang L, Starr A. Durability of pericardial versus porcine bioprosthetic heart valves. The Journal of Thoracic and Cardiovascular Surgery. 2012;144(6):1381-1386.
  8. Biglioli P, Spampinato N, Cannata A, et al. Long-term outcomes of the Carpentier-Edwards pericardial valve prosthesis in the aortic position: effect of patient age. J Heart Valve Dis. 2004;13(1):S49-51. (队列大小= 327,平均年龄= 67.2± 10.6岁。未报告最后一次随访时生物瓣膜置换的风险数量)
  9. Bergoënd E, Aupart MR, Mirza A, et al. 20 years’ durability of Carpentier-Edwards Perimount stented pericardial aortic valve. In: Yankah CA, Weng Y, Hetzer R,eds. Aortic Root Surgery The Biological Solution. Berlin: Springer; 2010:441-451. (队列大小= 1857,平均年龄= 69.8岁,未报告最后一次随访时结构性瓣膜恶化的风险数量)
  10. Aupart MR, Mirza A, Meurisse YA, et al. Perimount Pericardial Bioprosthesis for Aortic Calcified Stenosis: 18-year Experience with 1133 Patients. J Heart Valve Dis. 2006;15(6):768-775. (队列大小= 1133,平均年龄= 72.6岁。最后一次随访时SVD风险的数量= 2)
  11. Bourguignon T, et al. Very Long-Term Outcomes of the Carpentier-Edwards PERIMOUNT Valve in Aortic Position. Ann Thorac Surg. 2015 Mar;99(3):831-7. (队列大小= 2659,平均年龄= 71± 10.4岁。结构性瓣膜恶化的外植体风险数量= 28)。
  12. Forcillo J, et al. Carpentier-Edwards Pericardial Valve in the Aortic Position: 25-Years Experience. Ann Thorac Surg 2013;96:486-93. (队列大小= 2405,平均年龄= 71岁。最后一次随访时结构恶化的风险数量= 30)
  13. Clinical Communiqu? Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis 20-year Results. Data on file at Edwards Lifesciences, 2003. (队列大小= 267,平均年龄= 65±12岁。对于≥ 65岁的患者,最后一次随访时由于SVD导致外植体风险的数量= 2)
  14. Johnston DR, Soltesz EG, Vakil N, et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015 Apr;99(4):1239-47. (队列大小= 12569,平均年龄= 71±11岁。在20年随访期间结构瓣膜恶化的外植体风险的数量= 54)。
  15. 临床试验报告: 研究编号;2011-02报告日期: 2016年2月25日;TRANSFORM数据库2015年12月3日。
  16. STS数据库期限为2011年7月至2012年12月。
  17. Al-Sarraf N, Thalib L, Houlihan M, Tolan M, Young V, McGovern E. Cross-clamp time is an independent predictor of mortality and morbidity in low- and high-risk cardiac patients. Int J Surg 2011;9:104-109
  18. Borger MA, Dohmen P, Moustafine V, Conradi L, Knosalla C, Richter M, Merk DR, Doenst T, Hammerschmidt R, Treede H, Dohmen P, Strauch JT. Randomized Multi-Center Trial of Minimally Invasive Rapid Deployment Versus Conventional Full Sternotomy Aortic Valve Replacement (CADENCE-MIS). The Annals of Thoracic Surgery, 2014.
  19. 临床试验报告 报告日期: 2016年6月7日;FOUNDATION数据库 2016年2月1日。

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