VDyne Announces First Patient Treated in TRIVITA US IDE Pivotal Study of the TriNova™ Transcatheter Tricuspid Valve Replacement System

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Postmedia has not reviewed the content. by Business Wire VDyne Announces First Patient Treated in TRIVITA US IDE Pivotal Study of the TriNova™ Transcatheter Tricuspid Valve Replacement SystemAuthor of the article: You can save this article by registering for free here. Or sign-in if you have an account.THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an AccountMAPLE GROVE, Minn. — VDyne Inc. (“VDyne”), a privately held medical device company developing an innovative transcatheter tricuspid valve replacement (TTVR) system, today announced that the first patient has been enrolled and treated in the TRIVITA US IDE pivotal study of the TriNova™ system. The randomized controlled study will compare TriNova head-to-head with the commercially available Edwards EVOQUE™ TTVR system.The TRIVITA trial (NCT07516444) initiation marks a significant milestone in advancing treatment for tricuspid regurgitation (TR). The prospective, global, multicenter, randomized (1:1) controlled study is designed to evaluate the safety and effectiveness of the TriNova TTVR system in patients with severe or greater tricuspid regurgitation who are suitable for valve replacement. The study will be conducted in the US and Europe with up to 70 sites participating. The first patient was enrolled at the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, and treated by Dr. Konstantinos Voudris, MD, PhD, Director, Center for Valve and Structural Heart Disease.Mike Buck, Chairman and CEO of VDyne, said; “Initiating our TRIVITA US IDE pivotal study represents an important milestone for VDyne following years of innovation by our dedicated team. The trial reflects our continued commitment to advancing treatment options for patients with TR and evaluating TriNova’s potential role in the evolving standard of care. As we rapidly activate new investigational sites and build enrollment momentum in TRIVITA, as well as continue enrollment in the ongoing VISTA US & VISTA Global trials, we are moving closer to our ambition of establishing TriNova as the preferred treatment option for TR patients globally.”“The benefits and importance of treating TR are quickly evolving as a growing number of patients seek treatment and TriNova represents a significant step forward in TR therapies, an outcome we intend to demonstrate through the US pivotal study,” commented Dr. Susheel Kodali, incoming Co-Director, Heart Valve Center at NYU Langone Medical Center and Study Chairman, Global Co-Principal Investigator for the TRIVITA pivotal study. “Enrolling the first patient in the US pivotal study brings hope for an improved standard of care. TriNova incorporates next-generation elements designed to offer unique side delivery and compatibility with tricuspid anatomy. The system is designed to operate independently of the leaflets & chordae, ensuring reliable annular anchoring and providing functional evaluation prior to final implantation.”Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againDr Nadira Hamid, Director of Interventional Echocardiography at Minneapolis Heart Institute and Scientific Director of the Echocardiography Core Laboratory at Minneapolis Heart Institute Foundation and Global Co-Principal Investigator of the TRIVITA US pivotal study, added; “The start of the US pivotal study represents an important step forward in developing improved treatment options for patients with tricuspid regurgitation. The data from US/European/Australian/Canadian early feasibility studies (EFS) and the ongoing VISTA trials have been very encouraging and have provided promising preliminary safety and performance data of TriNova. I am looking forward to this next phase of the TriNova clinical program as we build enrollment momentum in the TRIVITA pivotal trial.”TriNova is being evaluated through a comprehensive clinical development program, which includes the ongoing VISTA US EFS study (NCT05848284), the VISTA Global EFS study (NCT05797519), and now the TRIVITA pivotal IDE study (NCT07516444).VDyne Inc. is a privately held medical device company based in Maple Grove, Minnesota, developing a transcatheter tricuspid valve replacement (TTVR) system for the treatment of tricuspid regurgitation.VDyne’s TTVR system is currently under clinical investigation and is not approved for commercial sale in the United States or any other jurisdiction.For more information, please visit www.vdyne.com.TriNova is a trademark of VDyne Inc.View source version on businesswire.com: For more information, please contact: Lance Scott +1-469-216-7134This advertisement has not loaded yet.Notice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. 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