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 advancements in treating severely calcified arterial disease. At TCT, held at the Moscone Center in San Francisco, AVS will exhibit from October 26 to 28 and host a symposium on October 27. The symposium will cover technology overviews and results from the POWER PAD II clinical trial. At VIVA, taking place at the Wynn Las Vegas, AVS will exhibit on November 3 and 4. Dr. Jon C George will present on Pulse IVL technology, and Dr. Chris Metzger will reveal primary safety and efficacy results from the POWER PAD II trial. This trial evaluates the Pulse IVL System for treating calcified peripheral arterial disease in the U.S.
Why It's Important?
The events at TCT and VIVA are significant as they provide a platform for AVS to present pivotal clinical trial results that could influence the future of intravascular lithotripsy (IVL) therapy. The POWER PAD II trial's outcomes are crucial for AVS's pursuit of FDA 510(k) clearance, which would allow commercial distribution of their Pulse IVL System. This development could offer a new treatment alternative for patients with calcified arterial disease, potentially improving patient outcomes and expanding treatment options in the U.S. healthcare market. Successful trial results and subsequent regulatory approval could position AVS as a key player in the medical device industry, impacting stakeholders including healthcare providers, patients, and investors.
What's Next?
Following the presentations at TCT and VIVA, AVS aims to leverage the trial results to secure FDA clearance for their Pulse IVL System. If successful, this could lead to the commercial availability of the device, offering a new therapeutic option for peripheral arterial disease. The company will likely engage with regulatory bodies, healthcare professionals, and potential investors to facilitate the system's market entry. The outcomes of these meetings could also influence future research directions and collaborations within the medical device sector.
