Xeltis Makes Strides with FDA Breakthrough Device Designation

Xeltis Achieves FDA Breakthrough Device Designation for aXess

Xeltis, a pioneering company in the field of medical technology, has received the prestigious Breakthrough Device Designation from the Food and Drug Administration (FDA) for its innovative product, aXess. This significant accolade signifies that aXess has the potential to provide a more effective vascular access option for patients undergoing dialysis. By improving the quality of care for renal disease patients, this development is set to make a remarkable impact in the medical community.

Understanding aXess and Its Implications

aXess is designed as a vascular access conduit that allows the creation of a permanent living vessel essential for hemodialysis procedures. This revolutionary system promises to bridge the gap between current vascular access methods and improved patient outcomes. A major advantage of the aXess system is its potential to reduce the frequency of reinterventions and the risk of infections, common complications faced by dialysis patients.

First Patient Treated in Pivotal Trial

Recently, Xeltis marked an important milestone by successfully treating the first patient in the staged pivotal trial for aXess in the United States. This event took place at the Flow Vascular Institute, with the procedure performed by esteemed vascular surgeon Dr. Karl Illig. The successful enrollment of the first patient heralds a new phase in the development and clinical validation of this innovative device.

Leadership Insights on aXess

Eliane Schutte, the Chief Executive Officer of Xeltis, shared her excitement regarding this designation, emphasizing that it acknowledges the groundbreaking potential of their technology. Schutte expressed pride in advancing toward commercialization, marking a transformative period for the company.

Dr. Karl Illig remarked on the groundbreaking nature of aXess, suggesting it could revolutionize the vascular access landscape. He highlighted the importance of reducing complications such as infections and repeated interventions—common hurdles of existing treatments.

Significance of the FDA Breakthrough Device Designation

The FDA’s Breakthrough Devices Program is designed to expedite the development and approval processes of medical devices that demonstrate the promise to significantly improve treatment for patients facing life-threatening or disabling conditions. The designation for aXess allows Xeltis to engage more frequently with the FDA, receive prioritized reviews, and potentially benefit from specialized reimbursement considerations. This strong support from regulatory authorities enhances Xeltis' pathway to market entry and speeds up the provision of this innovative solution to patients.

Upcoming Presentations and Clinical Trials

Exciting presentations regarding aXess will be featured at the upcoming VEITH Symposium, where doctors will discuss the promising clinical data supporting the device. Dr. John Lucas III will update audiences on the ongoing US IDE pivotal study, while Prof. Frans Moll will present the full two-year results from the initial study conducted in Europe.

This upcoming data not only showcases the efficacy of aXess but also solidifies Xeltis’ commitment to transforming patient care. The outcome of these trials is keenly awaited by both clinicians and patients as it represents a significant advancement in the field of vascular access.

About Xeltis

Xeltis is a visionary medtech company focused on developing transformative medical implants that harness the body's own regenerative capabilities. The company is committed to addressing the significant healthcare challenges faced by patients in need of hemodialysis access grafts and cardiovascular replacements. Through its proprietary endogenous tissue restoration (ETR) platform, which uses an advanced polymer implant, Xeltis aims to regenerate patients' own tissue, gradually replacing the implant with living, durable vessels.

With its headquarters in both The Netherlands and the USA, Xeltis continues to attract investments from various sources, ensuring its growth and innovative endeavors. The journey of Xeltis and its flagship product aXess demonstrates the potential of technology to reshape medical practices and enhance patient quality of life.

Frequently Asked Questions

What is aXess?

aXess is a vascular access conduit developed by Xeltis designed to create a permanent living vessel for patients undergoing hemodialysis.

What is the significance of the FDA Breakthrough Device Designation?

This designation accelerates the approval process and facilitates increased interactions with the FDA, benefiting the development of innovative medical devices.

Who performed the first patient treatment in the US trial?

The first patient treatment in the aXess US clinical trial was performed by Dr. Karl Illig at the Flow Vascular Institute.

What are the advantages of aXess over existing treatments?

aXess aims to reduce the frequency of reinterventions and the risk of infections compared to traditional dialysis access solutions.

Where are Xeltis' headquarters located?

Xeltis is headquartered in The Netherlands and the USA, supporting its global ambitions in medical technology innovation.

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