XeltisAnnounce its core productaXessCompleted the first clinical enrollment in the United States (aXess US).At that time, the product was granted the "Breakthrough Device" designation by the FDA.
PI Evaluation
"aXess has the potential to be a truly groundbreaking advancement in the field of vascular access, as it can create a new, permanent, living blood vessel. We hope it will help avoid frequent re-interventions and infections associated with current treatment options, which will have a significant impact on patients and their care."
---Karl Illig Flow Vascular Institute in Houston"The American aXess study is an important step in evaluating and validating the ability of this unique artificial blood vessel to change the field of vascular access. The 12-month data from the first human study in Europe is very promising, and I look forward to working on Xeltis' next clinical stage."
---John Lucas III Lucas Surgical Group
Executive Evaluation
"We are in a transformative period for Xeltis, and the FDA’s granting of 'Breakthrough Device' designation is strong recognition of the potential significance of our highly novel technology. We are also extremely proud to see that the first patient in our pivotal U.S. trial has now been treated, providing tremendous momentum as we advance towards commercialization."
---Eliane Schutte CEO of Xeltis
Last year,XeltisPublicationaXessA twelve-month clinical study in Europe demonstrated excellent clinical outcomes (secondary patency rate of 100%, primary assisted patency rate of 78%, and infection rate of 0).XeltisExcellent clinical outcomes provide substantial insights in the U.S. IDE study.In order to proceed more smoothlyXeltisMultiple products under its umbrella are in clinical trials.XeltisAppointed at the beginning of this monthLuc Verhees for clinical operationsVice President. Luc Verhees has over 30 years of cardiovascular experience and has worked at LivaNova (Sorin) and Medtronic., Boston Scientific, Spectranetics, Novoste, Corevalve, and Highlife (Edwards) etc.
aXessIs a used forRestorative synthetic electrospun blood vessels for arteriovenous hemodialysis access, over time, become autologous vessels identical to the patient's own blood vessels.aXessPrepared by electrospinning technology, it possesses a dense porous microstructure. Due to the presence of these porous microstructures, the patient's own tissue can quickly fill into them and eventually form a "living" blood vessel (identical to the patient's own blood vessels).aXessThe technology used is called: Endogenous Tissue Restoration (ETR). ETR is a new treatment method that enables the patient's own body to naturally regenerate new blood vessels or heart valves.ETR is throughXeltisThe porous structure of the products is achieved, which are made from bioabsorbable polymers and based on materials developed using Nobel Prize-winning technology.Application of ETR Technology,XeltisNot limited toaXess, currentlyXeltisIt has been extended to the pulmonary valve, aortic valve, and coronary artery bypass grafting (CABG).
XeltisXeltis AG is a clinical-stage medical device company developing the most advanced polymer-based cardiovascular therapeutic repair devices.XeltisThe repair devices include those used for coronary artery bypass grafting surgery and hemodialysis vascular access, heart valves, and small-diameter blood vessels.XeltisIt was formed by the merger of two enterprises incubated by Dutch/Swiss universities and currently operates in the Netherlands and the United States.
