NuVera Medical has announced positive results from its first-in-human feasibility study, assessing its intracardiac echocardiography (ICE) catheter, which were highlighted in an abstract presentation at the TCT Connect 2020 (14–18 October, virtual) meeting. The study was performed by principal investigator Adrian Ebner (Universidad Nacional de Asuncion, Asuncion, Paraguay), and the data were presented at TCT Connect by Azeem Latib (Montefiore Medical Center, New York, USA).
“Initial clinical experience of the NuVision ICE catheter supports safe and effective use with all primary and secondary safety and performance endpoints met and zero adverse events reported,” commented Latib. “This state-of-the-art 4D ultrasound technology will undoubtedly be the future of procedural guidance across a wide range of electrophysiology and structural heart procedures. I look forward to the benefit this advancement will bring to my practice and for my patients.”
One of the first virtually-supported clinical studies performed during the COVID-19 pandemic, the prospective, non-randomised, single-centre first-in-human study investigated the feasibility of the NuVision ICE catheter in visualising anatomical structures in patients being evaluated for structural heart procedures such as atrial septal defect (ASD) or patent foremen ovale (PFO) closure, left atrial appendage (LAA) closure, and mitral or tricuspid valve repairs.
“The NuVision ICE catheter provided me a completely new perspective in imaging of complex intracardiac structures and I could easily visualise the structures for catheter guidance,” stated Ebner. “All procedures were performed under conscious sedation and did not require intubation, which reduced overall length of stay, exposure to fluoroscopy and staffing demands. I believe NuVera’s novel solution has the potential to be an alternative to TEE for procedural guidance in structural heart interventions.”
“We are very pleased with the results of the initial patient experience and thank the outstanding clinical team for making this virtually-supported study a success,” said Todor Jeliaskov, president and CEO of NuVera Medical. “We are happy to see the NuVision ICE catheter simplified complex procedures for greater physician and patient benefit and look forward to building on this clinical experience as we prepare to bring our advanced imaging technology to market.”