This section highlights FDA-related milestones and regulatory updates for drugs developed by Haemonetics (HAE).
Over the past two years, Haemonetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VASCADE, VASCADE, NexSys, and SavvyWire®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
VASCADE MVP® XL FDA Regulatory Events
VASCADE MVP® XL is a drug developed by Haemonetics for the following indication: Large-Bore Venous Access Closure Procedures.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VASCADE MVP® XL
- Announced Date:
- April 24, 2026
- Indication:
- Large-Bore Venous Access Closure Procedures
Announcement
Haemonetics Corporation announced the publication of a new study comparing its VASCADE MVP® XL vascular closure system with the VASCADE MVP® venous vascular closure system in the context of large‐bore venous access closure procedures.
AI Summary
Haemonetics Corporation announced the publication of a new study that directly compares its VASCADE MVP® XL vascular closure system with the VASCADE MVP® venous vascular closure system for large‑bore venous access closure procedures. The study examines how the two devices perform in closing large venous access sites, focusing on clinical outcomes and procedural performance relevant to clinicians who manage patients requiring large‑bore access.
Clinical data related to the VASCADE MVP XL will be presented and discussed at HRS 2026 during a Haemonetics‑sponsored Rhythm Theater session titled "Efficient Workflows for AF Ablation: New Technologies and Sites of Service," scheduled for Saturday, April 25, 2026, at 10:30 a.m. CT. Haemonetics also included a standard cautionary statement regarding forward‑looking information in its announcement.
Read Announcement
VASCADE FDA Regulatory Events
VASCADE is a drug developed by Haemonetics for the following indication: Vascular closure.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VASCADE
- Announced Date:
- March 30, 2026
- Indication:
- Vascular closure
Announcement
Haemonetics Corporation announced U.S. Food and Drug Administration (FDA) approval to expand the labeling for the VASCADE MVP® XL venous vascular closure system to include procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths.
AI Summary
Haemonetics Corporation announced U.S. Food and Drug Administration approval to expand the labeling for the VASCADE MVP® XL venous vascular closure system. The updated labeling covers use with procedural sheaths that have a 10–14F inner diameter (ID) and up to a 17F outer diameter (OD). The VASCADE MVP XL is designed to close venous access sites after catheter-based procedures.
This change lets clinicians use the VASCADE MVP XL with larger-bore sheaths commonly employed in market-leading pulsed field ablation (PFA) and left atrial appendage closure (LAAC) procedures. Expanding compatibility to these sizes can make the device an option for a wider range of structural and electrophysiology interventions that require larger sheath diameters.
By aligning closure-device labeling with evolving catheter sizes, the approval may help simplify device choice and procedural planning, supporting teams that manage hemostasis and post-procedure care in large-bore venous access cases.
Read Announcement- Drug:
- VASCADE
- Announced Date:
- August 15, 2024
- Indication:
- Vascular closure
Announcement
Haemonetics Corporation announced the full market release of its VASCADE MVP® XL mid-bore venous closure system.
AI Summary
Haemonetics Corporation announced the full market release of its innovative VASCADE MVP® XL mid-bore venous closure system. This advanced system is now available to U.S. hospitals and is designed for procedures using larger sheaths, such as cryoablation, Pulsed Field Ablation, and Left Atrial Appendage Closure. The system features an innovative collapsible disc technology and a proprietary resorbable collagen patch to promote rapid hemostasis. It uses 58% more collagen and a larger disc than the previous VASCADE MVP® system, providing a stronger closure solution for procedures requiring 10-12F sheaths, with an outer diameter of up to 15F. Previously released on a limited basis in June 2024, the positive feedback from around 80 physicians across more than 30 hospitals has paved the way for its full market launch. This release reinforces Haemonetics’ commitment to enhancing vascular closure solutions and improving patient outcomes.
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NexSys PCS FDA Regulatory Events
NexSys PCS is a drug developed by Haemonetics for the following indication: Designed to improve the key performance indicators that matter to you: Productivity, Quality & Compliance, Yield, and Donor Satisfaction.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NexSys PCS
- Announced Date:
- February 23, 2026
- Indication:
- Designed to improve the key performance indicators that matter to you: Productivity, Quality & Compliance, Yield, and Donor Satisfaction.
Announcement
Haemonetics Corporation announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the NexSys PCS® Plasma Collection System with Persona® PLUS technology.
AI Summary
Haemonetics announced U.S. Food and Drug Administration 510(k) clearance for the NexSys PCS Plasma Collection System with Persona PLUS technology. NexSys PCS is an advanced, fully integrated system designed to streamline plasma collections and reduce cost-per-liter by improving yield, productivity, safety, quality, compliance, and donor satisfaction.
The clearance was supported by clinical data from a prospective, randomized, controlled, multicenter pivotal trial that included more than 30,000 plasma donations from nearly 3,000 donors. The study demonstrated the system’s safety and effectiveness and found that Persona PLUS delivered, on average, a mid–single-digit percent increase in plasma collected per donation compared with the prior Persona technology.
Haemonetics says Persona PLUS can help plasma collectors meet rising demand for plasma-derived therapies by increasing yields and lowering cost-per-liter while maintaining safety and a positive donor experience. Even a small percentage gain per donation can translate into meaningful additional volume across large collection programs.
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SavvyWire® FDA Regulatory Events
SavvyWire® is a drug developed by Haemonetics for the following indication: Pre-Shaped Pressure Guidewire.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SavvyWire®
- Announced Date:
- July 30, 2024
- Indication:
- Pre-Shaped Pressure Guidewire
Announcement
Haemonetics Corporation y announced CE Mark certification and the first commercial European procedures for the SavvyWire® Pre-Shaped Pressure Guidewire.
AI Summary
Haemonetics Corporation announced that its SavvyWire® Pre-Shaped Pressure Guidewire has received CE Mark certification, allowing the company to begin introducing this innovative guidewire into European and other international markets that recognize the CE mark. This sensor-guided, 3-in-1 solution is designed for Transcatheter Aortic Valve Implantation (TAVI) procedures and offers predictable performance, hemodynamic measurement, and left-ventricular pacing capabilities.
The first commercial European procedures using the SavvyWire guidewire were recently performed in France at Hôpital Haut-Lévêque, Centre Hospitalier Universitaire de Bordeaux, and in The Netherlands at Catharina Ziekenhuis Eindhoven. These early procedures demonstrate the device’s potential to simplify TAVI by reducing device exchanges and providing continuous monitoring, which may lead to improved procedural efficiency and patient outcomes.
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