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CAUTION: The Intrepid™ Transcatheter Mitral Valve Replacement System is an investigational device. Limited by federal (United States) law to investigational use. Exclusively for clinical investigations. Not approved by FDA and not for sale in the United States.
Primary Endpoint
Secondary Endpoint
The Intrepid Transcatheter Mitral Valve Replacement System (TMVR) integrates self-expanding stent technology with a tissue heart valve to facilitate minimally invasive, catheter-based implantation.
The prosthesis is compressed inside a hollow delivery catheter and implantation is completed through either transapical (TA) or transfemoral (TF) access. It is designed to engage and conform to the native annulus without need for additional sutures, tethers, or anchors.
The device design features:
Read through the inclusion/exclusion criteria and view more resources to help you determine if you have patients who are eligible to participate in the trial.
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Use the button below to send an email to your colleagues about the trial. This email template is prepopulated with basic information about the trial and a link to the website where your colleagues can learn more.
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U.S. Census Bureau. Statistical Abstract of the U.S.: 2006, Table 12.
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Kaneko T, Hirji S, Percy E, et al. Characterizing Risks Associated With Mitral Annular Calcification in Mitral Valve Replacement. Ann Thorac Surg. December 2019;108(6):1761-1767.