Saranas, Inc. today announced completion of the first U.S. commercial case using the Early Bird® Bleed Monitoring System for real-time detection and monitoring of endovascular bleed complications. Dr. Robert Kipperman, co-director of the Structural Heart Disease Program at Morristown Medical Center, and Dr. Bledi Zaku, cardiothoracic surgeon, successfully used the Early Bird 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.

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

“We are excited to witness the success of the first commercial case of this breakthrough technology,” said Saranas President and CEO Zaffer Syed. “The U.S. market anticipation of Early Bird has been overwhelmingly positive, and we are poised to initiate broader U.S. distribution of the Early Bird in the coming months, offering physicians and their patients a dedicated solution to enhance safety in endovascular procedures.”

The Early Bird addresses a large and growing unmet need. One in five patients experience a bleeding complication during large-bore endovascular procedures, such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR) and percutaneous hemodynamic support. Further, a 2017 report in the Journal of the American Medical Association (JAMA) reported a three times increase in mortality, two times increase in length of stay and 60 percent increase in healthcare costs due to these type bleeding complications.

“The Early Bird is a transformative technology that provides physicians with the ability, for the first time, to effectively monitor the bleed status of the patient during and post endovascular procedures, receive timely notifications of actual bleeds, and potentially reduce the severity of bleeding complications,” stated Dr. Philippe Généreux, Chief Medical Officer at Saranas. “Compared to the current paradigm of waiting for symptoms, which could take hours to develop, the Early Bird allows physicians to detect bleeding in real-time and take the necessary actions quickly to protect the outcomes of the procedure and aid recovery for the patient.”

Saranas was granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird in March of this year. The company presented first-in-human results in May 2019 at the Society for Cardiovascular Angiography Interventions (SCAI), 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.

Source: Company Press Release