FDA Approves RelayPro Thoracic Stent Graft System for Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers Treatment
The United States Food and Drug Administration (FDA) on March 7, 2023 approved the RelayPro Thoracic Stent Graft System, a new medical device for the treatment of thoracic aortic aneurysms and penetrating atherosclerotic ulcers. Manufactured by Bolton Medical, a Vascutek Terumo Company, the RelayPro system is designed to provide a less invasive alternative to traditional surgical procedures for these conditions.
The Devise
The RelayPro system consists of a series of thin, flexible tubes made of a biocompatible polymer material, which are inserted into the damaged portion of the aorta through a small incision in the groin. Once in place, the tubes are expanded to create a new, reinforced pathway for blood flow, helping to prevent further damage to the aorta.
Clinical Trials
The FDA’s approval of the RelayPro system was based on the results of two clinical studies involving over 50 patients each. These studies demonstrated that the system was effective in treating thoracic aortic aneurysms and penetrating atherosclerotic ulcers, with a low rate of serious adverse events.
The RelayPro system is expected to be a valuable new tool for healthcare providers treating patients with these conditions, offering a less invasive and more efficient alternative to traditional surgical procedures. However, as with any medical treatment, patients and healthcare providers should carefully consider the risks and benefits of the therapy before deciding to use it.
Conclusion
Overall, the FDA’s approval of the RelayPro Thoracic Stent Graft System represents an important advance in the treatment of thoracic aortic aneurysms and penetrating atherosclerotic ulcers, and provides new hope for patients with these conditions.
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