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November 5, 2019

First Commercial Case in United States Performed With Saranas' Early Bird Bleed Monitoring System

November 6, 2019—Saranas, Inc. announced the completion of the first United States commercial case using the company's Early Bird bleed monitoring system for real-time detection and monitoring of endovascular bleed complications.

Robert Kipperman, MD, Codirector of the Structural Heart Disease Program at Morristown Medical Center, and Bledi Zaku, MD, cardiothoracic surgeon, used the Early Bird device to monitor for bleed complications during a transcatheter aortic valve replacement (TAVR) procedure conducted at the Gagnon Cardiovascular Institute, Morristown Medical Center in Morristown, New Jersey.

Dr. Kipperman commented in the company’s announcement, “We are excited to be the first program worldwide to incorporate the use of the Early Bird into our endovascular cases. The Early Bird device was easily integrated into our standard workflow and provides meaningful information to secure and optimize patient outcomes.”

According to Saranas, the Early Bird addresses bleeding complications during large-bore endovascular procedures, such as TAVR, endovascular aneurysm repair (EVAR), and percutaneous hemodynamic support. The system includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath. The device is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures where the femoral artery or vein is used to obtain vascular access. Visual and audible indicators on the Early Bird device notify the clinician of the onset and progression of bleeding events.

In March 2019, Saranas announced that de novo classification was granted by the FDA for the Early Bird. In May, the company announced first-in-human results demonstrating that the Early Bird bleed monitoring system is safe, easily incorporated into standard workflows, and able to detect bleeding before progression to a more severe or symptomatic phase. The findings were presented at SCAI 2019, the Society for Cardiovascular Angiography Interventions annual scientific sessions held May 19–22 in Las Vegas, Nevada.

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November 6, 2019

Edwards' Sapien 3 TAVR System Approved in Europe for Low-Risk Patients

November 6, 2019

Edwards' Sapien 3 TAVR System Approved in Europe for Low-Risk Patients