BOSTON, March 30, 2026
In a significant advancement for interventional cardiology and electrophysiology procedures, Haemonetics Corporation announced that the U.S. Food and Drug Administration (FDA) has granted approval for expanded labeling of its VASCADE MVP® XL venous vascular closure system, enabling its use with larger sheath sizes. This milestone strengthens the company’s position in the rapidly evolving vascular closure market and supports broader adoption across advanced cardiac procedures.
Expanded Indication Unlocks Advanced Cardiac Procedures
The updated labeling now allows the VASCADE MVP XL system to be used with 10–14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths, a crucial enhancement for next-generation treatments such as pulsed field ablation (PFA) and left atrial appendage closure (LAAC). These procedures are increasingly utilized in managing atrial fibrillation, one of the most prevalent cardiac rhythm disorders globally.
This expansion eliminates the need for physicians to downsize sheaths prior to closure, a step that traditionally added complexity and time to procedures. By enabling direct closure of larger access sites, the device significantly improves procedural efficiency, reduces intervention time, and enhances workflow in both hospitals and ambulatory surgical centers. The system’s innovative design supports consistent hemostasis while maintaining safety across high-demand clinical settings, making it a valuable tool for clinicians managing complex cardiovascular interventions.
Clinical Evidence Demonstrates Strong Safety Outcomes
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The FDA’s approval was backed by robust clinical data from the AMBULATE EXPAND trial, a prospective, multicenter, single-arm pivotal study evaluating safety and effectiveness in procedures involving large-bore sheaths. The study enrolled 77 patients across eight U.S. centers, delivering compelling results that underscore the system’s clinical reliability.
Notably, the trial reported 0% major and 0% minor access site closure-related complications, highlighting the device’s exceptional safety profile. Additionally, the median time to ambulation (TTA) was just 2.4 hours, demonstrating faster patient recovery and supporting same-day discharge protocols. These findings were presented at a leading cardiology conference and published in a peer-reviewed journal, reinforcing their scientific credibility.
Such outcomes are critical in modern healthcare environments where reducing complications, improving patient throughput, and enhancing overall care efficiency are top priorities. The evidence positions the VASCADE MVP XL system as a clinically validated solution capable of meeting the demands of advanced electrophysiology procedures.
Innovative Technology Driving Market Leadership
The VASCADE MVP XL system incorporates a 25F collapsible disc technology combined with a resorbable thrombogenic collagen patch, designed to achieve rapid and reliable vascular closure. This extravascular approach minimizes risks associated with intravascular devices while promoting natural healing.
With this expanded indication, the system becomes the only extravascular venous closure solution clinically proven for use in electrophysiology procedures involving up to 17F OD sheaths, setting a new benchmark in the category. The broader VASCADE portfolio also includes solutions tailored for small-bore and mid-bore closures, enabling Haemonetics to address a wide spectrum of clinical needs.
Company leadership emphasized that the expanded approval aligns with growing demand for advanced cardiac procedures and positions Haemonetics to accelerate its commercial strategy. As healthcare providers increasingly adopt technologies like PFA and LAAC, the need for reliable, efficient vascular closure systems is expected to rise significantly.
By combining clinical validation, procedural efficiency, and innovative design, Haemonetics is reinforcing its role as a key player in the global MedTech landscape. The latest FDA approval not only enhances the clinical utility of its flagship product but also supports improved patient outcomes, reduced hospital stays, and optimized healthcare delivery.
Source: Haemonetics press release
