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Company intelligence / Profile preview
BlackSwan Vascular
Hayward, California, United States
- Ownership
- Private
- Development stage
- Other
01
Overview
The pivotal LAVA Study enrolled 113 patients at 20 centers and demonstrated that the Lava LES exceeded safety and efficacy performance goals. Safety was measured by freedom from major adverse events at day 30; effectiveness was defined as no bleeding from the target lesion after embolization with no need for emergency surgery or reintervention at day 30. FDA premarket approval was granted based on these results.
- Therapeutic areas
- OncologyCardiovascular
- Modalities
- DeviceLiquid embolic agent
- Industry
- Therapeutic Medical Devices
02
Partnerships
Sirtex MedicalGrand Pharmaceutical
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