JenaValve TAVR wins FDA breakthrough device designation


2020-01-10 10:20:11 Mass Device


JenaValve Technology said today that FDA has granted breakthrough device designation for its JenaValve Pericardial TAVR. The designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. It means that FDA will provide the Irvine, Calif.–based company with priority review and interactive communication regarding device development and clinical trial protocols. “We are clearly encouraged by this positive decision by the FDA regarding the expedited review of our unique TAVR system for patients suffering from severe aortic regurgitation who are at high risk for surgery and for which no transcatheter valve device is labeled or approved in the U.S. We look forward to continued collaborative interactions with the FDA as we move to finalize our clinical development program,” JenaValve CEO John Kilcoyne said in a news release. The JenaValve Pericardial TAVR System includes a bioprosthesis, with a self-expanding nitinol stent and a porcine pericardial valve. JenaValve boasts of employing what it describes as state-of-the-art tissue processing techniques. The TAVR system comes in three sizes. Transcatheter aortic valve replacement continues to be a hot space in the medical device industry, with recent studies suggesting that TAVR overall could be a safe alternative to traditional surgery. FDA last year cleared heart valves made by TAVR leaders Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) for use in patients at low risk from open-heart surgery — an expansion of potential uses for the technology.  
JenaValve 技术公司今天表示, FDA 已经为其 JenaValve 心包 TAVR 授予了突破性的设备设计。 指定用于严重主动脉瓣返流( AR )和 AR-显性混合主动脉瓣疾病。这意味着 FDA 将提供加利福尼亚州的欧文。基于优先审查和设备开发和临床试验协议的交互式通信的公司。 “ FDA 对快速审查我们独特的 TAVR 系统的积极决定显然鼓舞了我们。 TAVR 系统适用于严重主动脉瓣返流患者,这些患者的手术风险很高,在美国没有任何经导管瓣膜装置被标记或批准。我们期待着在最终完成我们的临床开发计划时继续与 FDA 合作。JenaValve 首席执行官 John Kilcoyne 在新闻发布会上说。 JenaValve 心包 TAVR 系统包括一个生物支架,带有一个自我扩张的镍钛诺支架和一个猪心包瓣膜。JenaValve 自豪地采用了它所描述的最先进的组织处理技术。TAVR 系统有三种尺寸。 经导管主动脉瓣置换仍然是医疗器械行业的一个热门领域,最近的研究表明 TAVR 整体上可能是传统手术的安全替代。FDA 去年清除了 TAVR 领导者美敦力(Medtronic)( NYSE : MDT )和 Edwards Lifesciences ( NYSE : EW )制造的心脏瓣膜,用于低风险的开放心脏手术患者——这是该技术潜在用途的扩展。