Innovalve transcatheter mitral valve replacement system: Short-term pre-clinical study in pigs

IF 2.2 Q2 ENGINEERING, MULTIDISCIPLINARY Applications in engineering science Pub Date : 2023-09-01 DOI:10.1016/j.apples.2023.100144

Avi Avner , Nicolas Borenstein , Boris Orlov , Ehud Raanani

{"title":"Innovalve transcatheter mitral valve replacement system: Short-term pre-clinical study in pigs","authors":"Avi Avner , Nicolas Borenstein , Boris Orlov , Ehud Raanani","doi":"10.1016/j.apples.2023.100144","DOIUrl":null,"url":null,"abstract":"<div><p>Innovalve is a transcatheter mitral valve replacement (TMVR) system with a unique fixation system that aims to grasp the chordae in a rotational maneuver.</p></div><div><h3>Objectives</h3><p>This study will examine the safety and efficacy of the transapical mitral implantation of Innovalve bioprosthesis in the porcine model.</p></div><div><h3>Methods</h3><p>Innovalve MV bioprosthesis was implanted in the porcine model (5 pigs) for a duration of 30 days.</p></div><div><h3>Results</h3><p>The Innovalve bioprosthesis was successfully implanted in all of the animals with accurate positioning, anchoring and good paravalvular sealing. At 30 days after implantation, all animals exhibited normal clinical status without evidence of cardiac impairment. The prosthetic valve seemed adequately adhered to the mitral annulus with fibrous tissue.</p></div><div><h3>Conclusion</h3><p>We have demonstrated that the implantation of the Innovalve in healthy porcine subjects is feasible and safe and that the valve function and interaction with normal biological tissue is favorable and predictable.</p></div>","PeriodicalId":72251,"journal":{"name":"Applications in engineering science","volume":"15 ","pages":"Article 100144"},"PeriodicalIF":2.2000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Applications in engineering science","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666496823000195","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENGINEERING, MULTIDISCIPLINARY","Score":null,"Total":0}

引用次数: 0

Abstract

Innovalve is a transcatheter mitral valve replacement (TMVR) system with a unique fixation system that aims to grasp the chordae in a rotational maneuver.

Objectives

This study will examine the safety and efficacy of the transapical mitral implantation of Innovalve bioprosthesis in the porcine model.

Methods

Innovalve MV bioprosthesis was implanted in the porcine model (5 pigs) for a duration of 30 days.

Results

The Innovalve bioprosthesis was successfully implanted in all of the animals with accurate positioning, anchoring and good paravalvular sealing. At 30 days after implantation, all animals exhibited normal clinical status without evidence of cardiac impairment. The prosthetic valve seemed adequately adhered to the mitral annulus with fibrous tissue.

Conclusion

We have demonstrated that the implantation of the Innovalve in healthy porcine subjects is feasible and safe and that the valve function and interaction with normal biological tissue is favorable and predictable.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

Innovalve经导管二尖瓣置换术:猪的短期临床前研究

Innovave是一种经导管二尖瓣置换术（TMVR）系统，具有独特的固定系统，旨在通过旋转操作抓住脊索。目的本研究将在猪模型中检验经心尖二尖瓣植入Innovave生物瓣膜的安全性和有效性。方法将Innovave MV生物瓣膜植入猪模型（5头），植入时间为30天。结果所有动物均成功植入Innovave生物瓣膜，定位准确，锚定牢固，瓣周密封良好。植入后30天，所有动物均表现出正常的临床状态，没有心脏损伤的证据。人工瓣膜似乎用纤维组织充分粘附在二尖瓣环上。结论我们已经证明，在健康猪受试者中植入Innovave是可行和安全的，并且瓣膜功能和与正常生物组织的相互作用是有利和可预测的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊