What's Happening?
Amplitude Vascular Systems (AVS), a medical device company based in Waltham, Massachusetts, has announced its participation in the upcoming Transcatheter Cardiovascular Therapeutics (TCT) and Vascular InterVentional
Advances (VIVA) meetings. The company will showcase its Pulse Peripheral Intravascular Lithotripsy (IVL) System, which is currently an investigational device not yet cleared for commercial distribution. AVS will host several events, including symposia and presentations, to discuss the results of the POWER PAD II U.S. pivotal trial. This trial evaluates the safety and efficacy of the Pulse IVL System for treating patients with moderate to severely calcified peripheral arterial disease. Key presentations will be made by Dr. Jon C. George and Dr. Chris Metzger, highlighting the technology and trial results.
Why It's Important?
The participation of AVS in these significant medical conferences underscores the potential impact of their Pulse IVL System on the treatment of calcified arterial disease. The results of the POWER PAD II trial are crucial as they could lead to FDA 510(k) clearance, allowing the device to enter the commercial market. This development is significant for the medical community as it offers a new therapeutic option for patients with peripheral arterial disease, potentially improving patient outcomes and expanding treatment options. The involvement of global investors and the focus on innovative medical technology highlight the growing interest and investment in advanced medical devices.
What's Next?
Following the presentations at TCT and VIVA, AVS aims to secure FDA clearance for its Pulse IVL System. The company will likely continue to engage with the medical community to demonstrate the efficacy and safety of its technology. Successful clearance could lead to broader adoption in clinical settings, impacting treatment protocols for arterial disease. Stakeholders, including healthcare providers and patients, will be closely monitoring the outcomes of these meetings and the subsequent regulatory decisions.
