What is the story about?
What's Happening?
Amplitude Vascular Systems (AVS), a Boston-based medical device company, is set to present 30-day results from its POWER PAD II U.S. pivotal trial at the Vascular InterVentional Advances (VIVA) meeting. The trial evaluates the safety and efficacy of AVS's Pulse IVL System for treating patients with severely calcified peripheral arterial disease. The study is the first Above-The-Knee Intravascular Lithotripsy pivotal IDE study conducted in the U.S. AVS aims to achieve FDA clearance and market availability for its Pulse IVL System, which is designed for easy delivery across complex calcified lesions.
Why It's Important?
The presentation of the POWER PAD II trial results is a significant milestone for AVS, as it could lead to FDA clearance and commercial availability of its Pulse IVL System. This innovative treatment for calcified arterial disease has the potential to improve patient outcomes and procedural efficiency, offering a new option in the evolving field of intravascular lithotripsy. The trial's success could pave the way for advancements in treating peripheral arterial disease, impacting patient care and expanding treatment options in the U.S. healthcare system.
What's Next?
Following the presentation at the VIVA conference, AVS will continue to seek FDA 510k clearance for its Pulse IVL System. Positive trial results could accelerate the system's market entry, providing healthcare providers with a new tool for treating calcified arterial disease. The company will focus on expanding its clinical and commercial operations, potentially influencing future developments in vascular treatment technologies.
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