NaviGate Cardiac Structures, Inc., presents data of studies on the Gate™ valved stent for correction of Functional Tricuspid Regurgitation at Paris PCR2016.


Jun 23, 2016   •  Announcement

Jose L Navia, M.D., from Cleveland Clinic presented the summary of animal studies of the Gatevalved stent for catheter-guided orthotopic implantation procedure for the correction of Functional Tricuspid Regurgitation (FTR).  Functional tricuspid regurgitation occurs yearly in close to 2 million patients in the USA, as reported by Stuge & Liddicoat previously.  These patients are for a large part categorized as inoperable by the STS (Society of Thoracic Surgery) guidelines, that is, at very high or prohibitive-risk of mortality if they undergo standard cardiac surgery under cardiopulmonary bypass due to the various co-morbidities they have.

The presentation was made in the Paris Percutaneous Revascularization Congress in May.  The Paris PCR2016, a meeting that occurs every May there and is the largest meeting in Europe for advances in catheter-guided therapies for cardiac and vascular disease in which new advances in technology are reviewed.  Dr. Navia’s presentation was the only valve replacement therapy presented for correction of FTR, all others were efforts in percutaneous repair for Mitral Regurgitation (MR) and TR.  It was noted that the methodology of valve replacement yielded total immediate correction of retrograde flow in the tricuspid position in studies in swine.  Methods Dr. Navia presented included the trans-atrial approach for tricuspid valve implantation and the early study of orthotopic tricuspid implant by trans-jugular catheter access, with survival to more than 150 days and a well-functioning tricuspid valve.

The presentation was well received, although as it is well known, the debate continues, whether the preferred technique 10 years forward will be replacement or repair.  It was noticed however, that in general replacement produces immediate abolition of TR that continues at a month or more, while all presently developing repair techniques present residual regurgitation immediately post-procedure and often worsening with time.

Dr. Navia’s presentation is found here under………PCR2016-V2013B.PDF

About NaviGate

NaviGate Cardiac Structures Inc. (www.navigatecsi.com) is an early-stage company focused on developing transcatheter solutions for the less-invasive treatment of atrioventricular valve regurgitation. The NaviGate valved-base technology was licensed from Cleveland Clinic and further modified and developed by NCSI.

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