The U.S. Food and Drug Administration approved an expanded labeling for Haemonetics Corporation’s VASCADE MVP XL venous vascular closure system on March 30, 2026. The new approval allows the device to be used with 10‑14F inner‑diameter and up to 17F outer‑diameter procedural sheaths, a size range that is required for many pulsed field ablation (PFA) and left atrial appendage closure (LAAC) procedures.
The expanded indication removes a previous limitation that forced clinicians to downsize sheaths before closure, a step that can add time and complexity to procedures. By enabling same‑size sheath use, Haemonetics can capture a larger share of the growing PFA and LAAC markets, which are projected to reach $800 million in addressable revenue. The VASCADE MVP XL system already features a 25F disc and a resorbable collagen patch that promotes rapid hemostasis, and the new labeling positions it as one of the few extravascular venous closure devices clinically proven for 17F sheaths in electrophysiology procedures.
Haemonetics’ management highlighted the strategic importance of the approval. Ken Crowley, Vice President and General Manager of Interventional Technologies, said, "VASCADE MVP XL has become the device of choice in advanced vascular closure, delivering differentiated clinical benefits and economic advantages for healthcare providers. With label expansion approval for fast‑growing PFA and LAAC technologies, we are poised to accelerate our commercial strategy and momentum, with opportunities to support a greater number and broader range of procedures at hospitals and ambulatory surgical centers across the U.S." The approval supports the company’s broader strategy to shift from low‑margin blood collection equipment to high‑margin hospital technologies.
Financially, Haemonetics has been expanding its hospital segment. In the fourth quarter of fiscal 2025, the company reported revenue of $331 million, a 4% decline on a reported basis but a 4% increase year‑over‑year excluding divestitures. Adjusted earnings per share were $1.24, beating analyst expectations of $1.22. Adjusted gross margin rose to 60.2%, up 620 basis points year‑over‑year, driven by volume growth in the Hospital segment and pricing benefits. CEO Chris Simon noted, "Our industry‑leading NexSys, TEG and VASCADE technologies continue to propel our growth in attractive markets, and we are on track to deliver all of the goals of our four‑year long‑range plan in fiscal 2026."
The expanded labeling is expected to broaden Haemonetics’ commercial footprint in electrophysiology and structural heart procedures, potentially boosting sales of the VASCADE line and reinforcing the company’s focus on high‑margin hospital technologies. The approval aligns with Haemonetics’ recent acquisitions and product developments in the interventional technologies portfolio, positioning the company to capture a larger share of the fast‑growing PFA and LAAC markets.
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