Device to detect internal bleeding wins De Novo clearance
- Houston-based Saranas announced Tuesday its device to detect and monitor internal bleeding during endovascular procedures has gained FDA clearance under the De Novo premarket review pathway.
- Invented at the Texas Heart Institute, the device includes a vascular access sheath with embedded sensors designed to catch and track bleeding from vessel injury that may occur during complex percutaneous procedures such as transcatheter aortic valve replacement (TAVR), the privately held medical device maker said.
- The Early Bird Bleed Monitoring System will be the first and only device on the market for real-time bleed detection, Saranas President Zaffer Syed, formerly of St. Jude Medical and Boston Scientific, said in the company's press release.
Saranas said its Early Bird system is intended to fill an unmet need by detecting and monitoring bleeding from vessel injury that may occur during endovascular procedures such as TAVR, large bore hemodynamic support device placement or other complex cardiovascular interventions where the femoral artery or vein is used for vascular access.
It's just the third De Novo clearance granted by FDA so far in 2019, according to an agency database.
A 2017 study in JAMA Cardiology that analyzed 17,672 patients in the National Inpatient Sample database of the Healthcare Cost and Utilization Project found bleeding complications occurred in 17.7% of patients who underwent TAVR, endovascular aneurysm repair or a percutaneous left ventricular assist device implant. Bleeding was associated with a statistically significant increase in mortality, length of hospital stay, and cost. The company notes that approximately one million U.S. vascular access procedure patients undergo similar experiences each year.
However, bleeding risk has been reduced for some percutaneous interventions due to the introduction of smaller catheter diameters and adoption of transradial artery vascular access, a commentary in NEJM Journal Watch notes.
The device detected internal bleeding with 100% sensitivity and 100% specificity in an animal study to support FDA review of its effectiveness, the company said. Saranas said it plans to commercially launch the device in select U.S. centers. It is currently being piloted in multiple centers to assess its ability to increase patient safety with improved monitoring during and after endovascular access procedures.
"Bleeding remains an Achilles' heel of advancing minimally invasive, catheter-based procedures," Dimitrios Karmpaliotis, director of chronic total occlusions, complex and high risk angioplasty at Columbia University Medical Center, said in a press release. "The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time."
- Business Wire FDA Grants Saranas De Novo Designation for the Early BirdTM Bleed Monitoring System
- JAMA Cardiology Mortality, Length of Stay, and Cost Implications of Procedural Bleeding After Percutaneous Interventions Using Large-Bore Catheters
- NEJM Journal Watch Large-Bore Catheters, Large Bleeding Risks