Today Saranas Inc. announced that it has submitted to the U.S. Food and Drug Administration (FDA) an application requesting Agency review and de novo classification of the Early Bird Bleed Monitoring System.
President and CEO Zaffer Syed commented, “This is an important milestone for Saranas as it illustrates the ability of our team to execute on our development and regulatory strategies.” Syed adds, “This submission, which incorporates recommendations provided by the FDA during pre-submission communications, is the culmination of the collective effort and success of our team in completing important biocompatibility, design verification testing, and preclinical animal studies. We look forward to continuing our preparation to bring this innovative technology to the market upon FDA clearance.”
The company describes 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 a transcatheter aortic valve replacement (TAVR), large bore hemodynamic support device placement, or other complex cardiovascular interventions, where the femoral artery or vein is used to obtain vascular access. The technology was invented at the Texas Heart Institute.
“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. “With this FDA submission, we are one step closer to providing a solution that has the potential to significantly reduce bleeding complications and improve clinical outcomes in patients undergoing endovascular procedures.”