October 14, 2020
NuVera Medical Presents Data From FIH Feasibility Study of NuVision 4D ICE Catheter
October 14, 2020—NuVera Medical, Inc., a portfolio company of Shifamed LLC focused on developing four-dimensional (4D) intracardiac echocardiography (ICE) imaging for transcatheter cardiac interventions, announced the presentation of results from the company’s first-in-human (FIH) feasibility study. The study’s principal investigator is Adrian Ebner, MD, Head of the Cardiovascular Department at the Universidad Nacional de Asuncion in Asuncion, Paraguay.
The prospective, nonrandomized, single-center FIH study investigated the feasibility of the NuVision ICE catheter in visualizing anatomic structures in patients being evaluated for structural heart procedures such as atrial septal defect or patent foramen ovale closure, left atrial appendage closure, and mitral or tricuspid valve repairs. The study, which was initiated in July 2020, has been virtually supported during the COVID-19 pandemic, noted the company.
Azeem Latib, MD, Director of Interventional Cardiology and Structural Heart Interventions at the Montefiore Medical Center in New York, New York, presented the data at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.
“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 Dr. Latib in NuVera’s press release. “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.”
Dr. Ebner added, “The NuVision ICE catheter provided me a completely new perspective in imaging of complex intracardiac structures and I could easily visualize the structures for catheter guidance. 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 transesophageal echocardiography for procedural guidance in structural heart interventions.”