NuVera announces positive data from FIH feasibility study at TCT meet
Category: #health  By Pankaj Singh  Date: 2020-10-16
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NuVera announces positive data from FIH feasibility study at TCT meet

NuVera Medical Inc., a privately held firm focused on developing novel imaging platform for complex cardiovascular procedures, has reportedly presented positive outcomes from its FIH (First-in-human) feasibility study evaluating ‘NuVision™ ICE Catheter’ at 32nd TCT (Transcatheter Cardiovascular Therapeutics) conference.

The clinical study was performed by Dr. Adrian Ebner, Head of cardiovascular department at UNA (Universidad Nacional de Asuncion) in Asuncion, Paraguay, and the abstract demonstrating the study were presented at TCT meet by Azeem Latib, Director for Interventional Cardiology and Structural Heart Interventions at Montefiore Medical Center in New York.

Sources cite it is a non-randomized, single-center, and prospective FIH study performed virtually during the COVID-19 pandemic. The study evaluated the feasibility of the ‘NuVision™ ICE Catheter’ in imagining anatomical structures in patients being assessed for complex structural heart procedures such as patent foremen ovale( PFO) closure, atrial septal defect (ASD), mitral or tricuspid valve repairs, and left atrial appendage (LAA) closure.

Speaking on the study Dr. Latib said that preliminary clinical experience of NuVision ICE Catheter supports effective and safe use and met primary as well as secondary performance and safety endpoints with no adverse events. This cutting-edge 4D ultrasound technology will be the future of procedural guidance across an extensive range of electrophysiology as well as structural heart procedures, he states.

Todor Jeliaskov, CEO and President of NuVera Medical said that the company is extremely pleased with the outcomes of the initial patient experience. The company is delighted to see how NuVision ICE Catheter streamlined complex procedures for greater physician and patient benefit and is looking forward to building on this experience as it prepares to bring this state-of-the-art imaging technology to market, he further stated.

He also thanked the company’s team for making this virtually-aided study a success.

Source credit - https://cardiovascularnews.com/tct-connect-2020-nuvera-announces-results-from-first-in-human-study-of-ice-catheter/



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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