What's Happening?
Amplitude Vascular Systems (AVS), a medical device company based in Boston, MA, announced it will present 30-day results from its POWER PAD II U.S. pivotal trial for Pulsatile Intravascular Lithotripsy (PIVL) therapy at the Vascular InterVentional Advances (VIVA) meeting in November. The trial evaluates the safety and efficacy of AVS's Pulse IVL System in treating patients with moderate to severely calcified peripheral arterial disease. The study is led by Chris Metzger, M.D., Interventional Cardiologist at Ballad Health in Kingsport, Tenn. The trial marks a significant milestone for AVS as it approaches FDA clearance and market availability for the Pulse IVL System.
Why It's Important?
The presentation of the POWER PAD II trial results is a critical step towards FDA clearance and commercial availability of the Pulse IVL System, which offers a new treatment option for calcified arterial disease. This innovative technology could significantly impact patient outcomes by providing a safer and more effective treatment method. The trial's success could pave the way for advancements in the treatment of peripheral arterial disease, potentially improving the quality of life for many patients. The development of new medical devices like the Pulse IVL System highlights the ongoing innovation in the healthcare industry, aiming to address complex medical conditions with advanced solutions.
What's Next?
Following the presentation at the VIVA conference, AVS will continue to seek FDA 510k clearance for the Pulse IVL System, aiming for commercial distribution. The company will likely focus on further clinical trials and studies to support the efficacy and safety of the device, while also preparing for market entry. Stakeholders, including healthcare providers and patients, will be closely monitoring the outcomes and potential availability of this new treatment option.
