NuVera Medical has announced the initiation of the company’s first-in-human clinical trial to evaluate the performance of its NuVision intracardiac echocardiography (ICE) catheter. The first study participant was successfully treated this month for an atrial septal defect by principal investigator Adrian Ebner (Cardiovascular Department, The Italian Hospital, Asuncion, Paraguay) using remote, live-feed support from the NuVera team who were located in the USA.
A company statement explains that the NuVision ICE catheter is designed to offer interventional cardiologists and electrophysiologists rapid, real-time 3D, multi-planar insights into structural heart and cardiac ablation which are difficult to detect with current technology and may require general anaesthesia. It says the wide, 90° x 90° view of the cardiac anatomy provided by the technology has the potential to better guide complex cardiac procedures, improve outcomes and reduce procedure times while lowering healthcare costs.
Todor Jeliaskov, CEO of NuVera Medical, says in the press release: “[This] marks a major milestone in the history of NuVera as we transition to a clinical-stage company. We see tremendous potential for the NuVision ICE catheter to transform complex cardiac procedures and look forward to bringing this beneficial technology to market.”
Ebner states: “I am extremely pleased to be part of the first use of this technology. Typically, a case involving a septal defect would require general anaesthesia and a separate sonographer to perform transoesophageal imaging. With the NuVision ICE catheter we were able to perform the procedure with virtual support from NuVera with the patient under conscious sedation. Viewing the intracardiac structures and leaflets from this perspective was entirely new, enabling a much more simplified septal repair procedure. The patient was discharged the next morning without any excess swelling from the use of TEE [transoesophageal.echocardiography].”
NuVera Medical is a portfolio company of Shifamed LLC.