Haemonetics (NYSE:HAE) announced new clinical data demonstrating superior safety for its vascular closure technology, just weeks after receiving expanded U.S. regulatory clearance to address a wider range of complex cardiac procedures.
The Boston-based medical technology company published results from a 574-patient single-center comparative study focusing on its VASCADE MVP XL mid-bore venous closure system.
The study found that the device achieved higher procedural success than alternative methods and, notably, reported 0% bleeding complications during large-bore venous access closure for electrophysiology procedures.
The clinical validation arrives at a pivotal moment for the company's interventional technologies segment.
In March 2026, the U.S. Food and Drug Administration (FDA) expanded the labeling for VASCADE MVP XL.
The updated clearance now covers sheaths with an inner diameter (ID) of 10–14F and up to a 17F outer diameter (OD), significantly broadening the device's utility in high-volume procedures such as atrial fibrillation ablations and left atrial appendage closures.
The FDA’s decision was underpinned by the AMBULATE EXPAND pivotal trial, a multicenter study designed to test the device’s efficacy in larger sheaths.
Additionally, a 31-patient ultrasound sub-study provided early vascular imaging results that supported the device’s safety profile, showing no significant structural abnormalities at the access site post-procedure.