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
SavvyWire® and VASCADE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SavvyWire® - FDA Regulatory Timeline and 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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VASCADE - FDA Regulatory Timeline and 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:
- 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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