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.

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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.

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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

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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/