AngioDynamics Submits 510(k) Application to FDA for AlphaVac Mechanical Thrombectomy System
AngioDynamics (NASDAQ: ANGO) announced the submission of a 510(k) application to the FDA for its AlphaVac System on April 9, 2021. This innovative thrombectomy device aims to treat undesirable intravascular materials in the venous system and peripheral vasculature. The AlphaVac System combines a mechanical aspiration handle with a self-expanding funnel tip, enhancing control and minimizing blood loss during procedures. The company anticipates the release of AlphaVac in the latter half of 2021, pending FDA clearance, as part of its strategy to expand its thrombus management portfolio.
- Submission of 510(k) application for AlphaVac System enhances product portfolio.
- AlphaVac System aims to penetrate the growing thrombectomy market.
- Collaboration with leading physicians to improve treatment capabilities.
- FDA clearance is still pending, delaying potential market introduction.
AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology today announced that on April 9, 2021, it submitted a 510(k) application to the United States Food and Drug Administration (FDA) for the AlphaVac System, an off-circuit, multi-purpose mechanical aspiration thrombectomy device for the treatment of undesirable intravascular material in the venous system and peripheral vasculature.
The AlphaVac System combines two of AngioDynamics’ proprietary technologies: a new mechanical aspiration handle and the Company’s innovative self-expanding funnel tip and is designed to provide precise control in the removal of clot burden while minimizing patient blood loss. Undesirable intravascular material can include thrombus, embolus, and vegetation found in a patient’s venous system, including the peripheral vasculature.
“We are excited to announce this important milestone in the ongoing transformation of our portfolio,” said Jim Clemmer, President and Chief Executive Officer of AngioDynamics. “Our team developed AlphaVac in collaboration with leading physicians to enable treatment in more cases without the need for perfusion while providing control, power and versatility to drive positive patient outcomes. AlphaVac expands our thrombus management portfolio allowing us to serve a larger, fast-growing segment of the thrombectomy market and we’re confident it will become a go-to treatment option for physicians.”
AngioDynamics anticipates the release of the AlphaVac System in the second half of calendar year 2021, subject to FDA clearance.
About AngioDynamics, Inc.
AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, peripheral vascular disease, and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products. For more information, visit www.angiodynamics.com.
AngioDynamics and AlphaVac are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary.
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