Saranas said today that the first clinical cases using its Early Bird endovascular bleed monitoring system were performed at Atlantic Health System’s Morristown Medical Center in Morristown, N.J.
The Early Bird device 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 in which the femoral artery or vein is used to obtain vascular access. The technology was invented at the Texas Heart Institute.
The first cases varied across multiple interventions including TAVR, hemodynamic support and standard percutaneous coronary interventions, the Houston, Texas-based company said in a statement.
“The Early Bird bleed monitoring system is designed to protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible, and life-threatening consequences occur,” said Saranas chief medical officer Dr. Philippe Généreux in the statement. “The initial clinical cases have successfully demonstrated the versatility and potential benefit of the Early Bird across a wide variety of case types.”
“Our goal in the development of the Early Bird bleed monitoring system is to provide doctors with a groundbreaking tool to reduce bleeding complications and to improve clinical outcomes in patients undergoing endovascular procedures,” said Saranas president & CEO Zaffer Syed. “As we expand our clinical pilot to multiple U.S. centers in the coming weeks, we look forward to gaining more insight and experience on the utility of bleed monitoring.”
Saranas will showcase the first-in-human experience with the Early Bird at the Transcatheter Cardiovascular Therapeutics (TCT) meeting Sept. 21-25, in San Diego, Calif.
In April, the company applied to the FDA for de novo classification for Early Bird. In June 2017, Saranas said it raised $4 million in a Series B round of financing to support the device.