What is the story about?
What's Happening?
Amplitude Vascular Systems (AVS), a medical device company specializing in treating severely calcified arterial disease, has announced the opening of its new global headquarters in Waltham, Massachusetts. The facility spans over 37,000 square feet and is designed to support innovation, operations, and commercialization efforts. This expansion is part of AVS's strategic growth as it prepares for the U.S. commercial launch of its novel device, the PULSE IVL System, which is aimed at treating peripheral and coronary artery disease. The new headquarters will facilitate the company's ongoing development and regulatory approval processes, including the POWER PAD II U.S. pivotal study for the use of pulsatile intravascular lithotripsy in femoropopliteal arteries.
Why It's Important?
The establishment of AVS's new headquarters in Waltham marks a significant milestone in the company's growth trajectory, enhancing its capacity to innovate and commercialize its medical devices. This expansion is crucial for AVS as it seeks regulatory approval and prepares to introduce its intravascular lithotripsy therapy to the U.S. market. The move is expected to create job opportunities and contribute to the vibrant life sciences ecosystem in the Greater Boston area. By advancing its research and development capabilities, AVS is positioned to make a substantial impact on the treatment of calcified arterial disease, potentially improving patient outcomes and expanding its market presence.
What's Next?
AVS is focused on completing the POWER PAD II Study, with primary endpoints to be presented at the VIVA Conference in November 2025. The company is also preparing for the commercialization of its first platform in mid-2026. As AVS continues to expand its operations, it will likely engage with regulatory bodies to secure necessary approvals and collaborate with industry partners to enhance its product offerings. The success of these initiatives could lead to further growth and innovation within the medical device sector.
AI Generated Content
Do you find this article useful?