Initial Clinical Cases Performed With Saranas Early Bird Bleed Monitoring System

September 18, 2018—Saranas Inc. announced that the first clinical cases with its Early Bird bleed monitoring system were performed at Atlantic Health System’s Morristown Medical Center in Morristown, New Jersey. In the coming weeks, the company will expand its clinical pilot to multiple centers in the United States to gain more insight and experience on the utility of bleed monitoring.

According to Saranas, the cases varied across multiple interventions including transcatheter aortic valve replacement (TAVR), hemodynamic support, and standard percutaneous coronary interventions. The company noted that the variety of procedures demonstrate the versatility of the Early Bird system to potentially improve patient safety with improved bleed status monitoring during and after endovascular access procedures, stated the company.

The Early Bird bleed monitoring system includes a vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as TAVR;large-bore hemodynamic support device placement; or other complex cardiovascular interventions where the femoral artery or vein is used for vascular access. The technology was invented at the Texas Heart Institute in Houston, Texas. The Early Bird bleed monitoring system is not yet approved by the FDA and is currently available for investigational use only, advised the company.

Findings from the first-in-human experience with Early Bird will be presented by Saranas' Chief Medical Officer Philippe Généreux, MD, at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics meeting held September 21–25 in San Diego, California.