Saranas said today that FDA has granted its Early Bird endovascular bleed monitoring system de novo designation.
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.
A recent study of more than 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database revealed that one in five patients experienced a bleed complication, according to the Houston, Texas-based company. A 2017 article in the Journal of the American Medical Association (JAMA) reported a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs of procedural bleeding after percutaneous interventions using large-bore catheters, it added.
“Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications,” said company president and CEO Zaffer Syed in a prepared statement. “As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”
In an animal study to support FDA review of the device’s effectiveness, the Early Bird was able to detect internal bleeds with 100% sensitivity and 100% specificity, according to the company.
“Bleeding remains an Achilles’ heel of advancing minimally-invasive, catheter-based procedures,” said Dimitrios Karmpaliotis, M.D., director of chronic total occlusions, complex and high-risk angioplasty at Columbia University Medical Center, in the statement. “The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time.”
“Peri-procedural bleeding associated with endovascular procedures has a significant impact on patient safety and adds incremental costs to the healthcare system with longer hospital stays and additional interventional treatment,” added Saranas chief medical officer Philippe Généreux, M.D. “I firmly believe the Early Bird bleed monitoring system will help 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.”
The Early Bird is currently being piloted in multiple centers to assess its ability to potentially increase patient safety with improved bleed status monitoring during and after endovascular access procedures. Saranas plans a limited commercial launch of the device in the U.S.