Treating severely calcified arterial disease

Amplitude Vascular Systems has developed an innovative medical device known as Pulse IVL™ (Intravascular Lithotripsy), designed to address the challenges posed by calcified arterial disease. This technology employs a unique mechanism of action that converts pressurized CO2 into high-frequency pulsatile energy waves, which are delivered at a rate of 15 pulses per second. These energy waves effectively fracture arterial calcium while simultaneously expanding the vessel, allowing for improved blood flow. The system's design enhances deliverability and usability, making it a valuable tool for healthcare providers treating patients with severe calcified arterial conditions.

Clinical evidence supports the efficacy of Pulse IVL™ in both pre-clinical and first-in-human studies, demonstrating its ability to achieve luminal expansion and produce full-thickness calcium fractures in diseased arteries. The device has shown promising results in treating both concentric and eccentric lesions, which broadens the range of patients who can benefit from this technology. With ongoing clinical trials, including the pivotal POWER PAD II study, Amplitude Vascular Systems aims to further validate the safety and effectiveness of Pulse IVL™ in treating peripheral arterial disease, ultimately improving patient outcomes and quality of life.

United States

AVS is an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease. It was founded in 2018 by Hitinder Gurm, M.D., Interventional Cardiologist and Chief Clinical Officer at University of Michigan, and Robert Chisena, Ph.D., Chief Technical Officer at AVS. We are redefining interventional therapy for severely calcified lesions with our Pulse IVL System, which uses a novel pulsatile mechanism of action to shatter calcium and expand narrowed vessels, all with a single device. To learn more about pulsatile intravascular lithotripsy, visit www.avspulse.com.

Amplitude Vascular Systems

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