Ep. 81 Endovascular Innovations: The Ellipsys story with Dr. Jeff Hull

Surgical arteriovenous fistula (AVF) creation has been a mainstay of dialysis care for multiple decades. What does it take to break into such an established space with a new endovascular medical device? In this episode of the BackTable Podcast, Dr. Jeffrey Hull discusses the challenging journey of developing the Ellipsys system for endovascular AVF creation. --- SYNPOSIS We trace Dr. Hull’s path from the device's initial conception in 2006, through the first-in-human cases in 2013, to regulatory approval and acquisition by Medtronic in 2020. Dr. Hull highlights the roles of key business mentors, the importance of multidisciplinary collaboration with vascular surgery and nephrology, and the impact of investment. He also shares valuable insights on the benefits of having competitors and selecting a well-thought-out exit strategy. Additionally, we explore deep vein arterialization (DVA) as another application of endovascular AVF creation in the context of peripheral arterial disease. --- TIMESTAMPS 00:00 - Introduction 03:05 - The Birth of the Percutaneous AV Fistula Creation 15:04 - First-in-Human Cases 17:58 - Navigating the Startup Journey 21:52 - Identifying Mentors and Investors 27:33 - Competition and Criticism 36:43 - Regulatory Hurdles 44:45 - Acquisition by Medtronic 49:14 - Deep Vein Arterialization for Peripheral Arterial Disease 54:40 - Final Thoughts and Advice --- RESOURCES Avenu Medical: https://avenumedical.com/ Gracz KC et al. Proximal forearm fistula for maintenance hemodialysis (1977): https://pubmed.ncbi.nlm.nih.gov/839655/ Hull JE et al. The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access (2018): https://pubmed.ncbi.nlm.nih.gov/29275056/ Endovascular Today- Update on Percutaneous AV Fistula Creation (2015): https://evtoday.com/articles/2015-june/update-on-percutaneous-av-fistula-creation Mallios A, Jennings WC. Percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System-the state of the art (2020): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8353338/