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July 6, 2020

NuVera Initiates First-in-Human Study of the NuVision ICE Catheter

July 6, 2020—NuVera Medical Inc., a portfolio company of Shifamed LLC, announced the initiation of the company’s first-in-human clinical trial to evaluate the performance of its NuVision intracardiac echocardiography (ICE) catheter. The study’s first patient was treated using the NuVision ICE catheter for an atrial septal defect by Principal Investigator Adrian Ebner, MD, Head of the Cardiovascular Department at the Italian Hospital Asuncion Paraguay. The procedure was conducted using remote, live-feed support from the NuVera team, who were located in the United States.

According to the company, the NuVision ICE catheter is designed to offer interventional cardiologists and electrophysiologists rapid, real-time, three-dimensional, multiplanar insights into structural heart and cardiac ablation. The wide, 90° X 90° view of cardiac anatomy provided by the technology has the potential to better guide complex cardiac procedures, improve outcomes, and reduce procedure times while lowering health care costs.

“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,” commented Dr. Ebner in the company’s announcement. “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 transesophageal echocardiogram.”

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