食品药品监管局 FDA 批准 Edwards Pascal 系统用于三尖瓣修复：加州 Irvine 医疗器械公司同日再获二尖瓣新适应证
总部位于加州橙县 Irvine 市的医疗器械公司 Edwards Lifesciences 10月21日宣布，美国食品药品监管局 FDA 已批准其 Pascal Precision 系统用于三尖瓣修复。这是该公司经导管瓣膜修复与置换产品线在美国市场拿下的又一关键批准。
根据公司公告，Pascal Precision 系统适用于在最佳药物治疗下仍有症状的重度三尖瓣反流患者，条件是患者被评估为手术风险中度或以上，并经多学科心脏团队判定适合接受经导管缘对缘三尖瓣修复（T-TEER）。公司称，该系统的差异化设计有助于医生在复杂解剖结构中操作。辛辛那提 The Christ Hospital Health Network 结构性心脏病项目主任 Santiago Garcia 医生说：「Pascal 系统的差异化特点在应对复杂、具挑战性的解剖结构时带来诸多好处，很高兴这项疗法现在能用于美国的三尖瓣患者。」该三尖瓣系统的 CLASP IITR 关键试验一年期结果将在 TCT 2026 大会上公布。
同日，食品药品监管局 FDA 还批准带 Capture Clarity 系统的 Pascal Ace 用于退行性二尖瓣经导管缘对缘修复（M-TEER）。该系统带有荧光透视指示标记，可在手术中确认瓣叶已被夹持——这是缘对缘修复中关键且具挑战性的一步。Garcia 医生表示，这些指示标记提供了一种新颖、简便的确认方式，简化了器械置入、提高了手术成功信心。至此，Edwards 在美国市场同时拥有覆盖二尖瓣与三尖瓣的修复与置换经导管疗法组合。
FDA Approves Edwards Pascal System for Tricuspid Valve Repair; Irvine-Based Company Also Wins New Mitral Clearance
Edwards Lifesciences, the medical device company headquartered in Irvine, in California's Orange County, announced on October 21 that the U.S. Food and Drug Administration (FDA) has approved its Pascal Precision system for tricuspid valve repair, another key U.S. approval for the company's transcatheter valve repair and replacement portfolio.
According to the company, the Pascal Precision system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy who are deemed at intermediate or greater risk for surgery and deemed appropriate for transcatheter edge-to-edge tricuspid valve repair (T-TEER) by a multidisciplinary heart team. The company said the system's differentiated features help physicians navigate complex and challenging anatomies. 'The differentiated features of the Pascal system provide many benefits in navigating complex and challenging anatomies, and it is exciting to now have this therapy available for our tricuspid patients in the United States,' said Santiago Garcia, MD, director of the Structural Heart Program at The Christ Hospital Health Network in Cincinnati, Ohio. One-year results from the CLASP IITR pivotal trial of the Pascal tricuspid system will be presented at TCT 2026.
The FDA also approved the Pascal Ace with Capture Clarity system for use in degenerative mitral transcatheter edge-to-edge repair (M-TEER) procedures. The system includes fluoroscopic indicators that provide confirmation when valve leaflets have been grasped, addressing a challenging step in edge-to-edge repair cases. Dr. Garcia said the indicators provide a novel and easy way of confirming leaflet capture, simplifying placement of the device and increasing confidence in achieving a successful outcome. With the approvals, Edwards now provides a portfolio of repair and replacement transcatheter therapies for both the mitral and tricuspid valves available in the United States.
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图片来源：图：心脏瓣膜手术（资料图）。维基共享资源，CC BY 4.0。
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