Texas Heart Institute Invention Receives FDA Clearance
A new device invented by Texas Heart Institute (THI) became the first and only device to be cleared by the FDA for early bleed detection. The device will provide real-time monitoring and detection of bleed complications during catheter-based surgeries and will alert doctors immediately when vessels are accidentally torn or injured.
The innovative technology called the Early Bird Bleed Monitoring System was conceived and developed by Dr. Mehdi Razavi, cardiologist and Director of Clinical Electrophysiology Research & Innovations at THI.
“Our system includes a vascular access sheath with embedded bioimpedance sensors that are designed to detect and monitor bleeding from vessel injury that may occur during endovascular procedures where doctors use the artery or vein in the leg to implant the device,” said Dr. Razavi. “These types of procedures include transcatheter aortic valve replacement (TAVR) and placement of a left ventricular assist device.”
In a preclinical 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. “In medicine, tests that are highly sensitive and highly specific mean they rarely fail to detect the complication they are designed to find and rarely mistake the complication for another. A sensitivity and specificity value above 90% is a respectable threshold and values above 99% are very rare,” added Dr. Razavi.