Tuesday, July 07, 2020
NuVera Medical Inc., a portfolio company of Shifamed LLC, focused on enabling a new era in transcatheter cardiac interventions through the advancement of real-time 3D intracardiac echocardiography (4D ICE), announced today initiation of the company's first-in-human clinical trial to evaluate the performance of its novel NuVision™ ICE Catheter. The first study participant was successfully treated this month for an atrial septal defect by principal investigator Adrian Ebner, M.D., Head of the Cardiovascular Department at the Italian Hospital Asuncion Paraguay, using remote, live-feed support from the NuVera team who were located in the U.S.
"I am extremely pleased to be part of the first use of this technology. Typically, a case involving a septal defect would require general anesthesia and a separate sonographer to perform transesophageal imaging," stated Dr. Ebner. "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."
NuVera's novel NuVision ICE Catheter is designed to offer interventional cardiologists and electrophysiologists rapid, real-time 3D, multi-planar insights into structural heart and cardiac ablation procedures, which are difficult to detect with current technology and may require general anesthesia. 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.
"Today marks a major milestone in the history of NuVera as we transition to a clinical-stage company," Todor Jeliaskov, CEO of NuVera Medical. "I am incredibly grateful to Dr. Ebner and the entire clinical team for their flawless performance and for trusting the NuVera team to remotely support the first human case. We see tremendous potential for the NuVision ICE Catheter to transform complex cardiac procedures and look forward to bringing this beneficial technology to market."
