- The preclinical results with the XABG restorative vascular graft in sheep have been submitted to and published in the Journal of the American College of Cardiology (JACC): Basic to Translational Science (
https://www.jacc.org/doi/10.1016/j.jacbts.2022.06.021(si apre in una nuova finestra))
- First 3 First-in-Human EU patients have received successful implantations, but encountered occluded grafts at 30 days follow-up
- A scientific and clinical expert panel of 20+ global experts was formed to help root cause analysis and mitigation strategy
- This expert panel identified the following multifactorial root cause:
o Screening: small targets with suboptimal run-off and competitive flow
o Implant: long grafts, sub-optimal geometries
o Post-op care: medication regimen
o Prolonged bleeding during implantation
- As as result of this, the panel provided the following recommendations:
o Intensified DAPT (Dual Anti-Platelet Therapy) with Clopidogrel (8/9 KOLs) | Most tested and excepted in CABG surgery (ACS patients)
o Careful monitoring of post-operative bleeding and patient individual adjustment of anticoagulation (i.e. dose, timing of Heparin & DAPT)
o DAPT recommended for a least 12 months
o Heparin & Protamine management equally important
o CT-Angio and POD 1 to confirm early patency
- Additionally, Xeltis developed the XABG-XS device to reduce implant length in an attempt to better control oversizing and trajectory, investigated an external sealant/hemostat to reduce time to hemostasis at time of implantation (commercially available Coseal was selected as a fast degrading hydrogel that provides immediate hemostasis), developed of a heparin coating to provide an antithrombotic surface as an alternative and conducted 4 different animal studies to test and confirm Coseal, heparin, new medication regime
- Xeltis subsequently executed these expert recommendations through protocol changes, medication improvement, significant product development efforts and additional animal studies. However, European sites remained hesitant to enrol out of caution until additional clinical evidence would confirm feasibility resuming enrolment.
- Consequently, Xeltis performed a 7-patient trial in Paraguay to demonstrate effectiveness of mitigation measures to provide EU sites with human proof-of-concept data post 3 months follow-up data and continue EU FIH trial
- In these additional clinical studies, the mitigation strategies identified have proven successful. Xeltis is now the first company in the world to show patent CABG conduit at 6-months of follow-up. In total, 9 out of the 15 First-in-Human patients have been enrolled.
- Excellent clinical data above have been received with great enthusiasm in European sites, with several new sites in process to be activated. Xeltis XABG remains the worlds most advanced solution as a suitable alternative to veins and targets to revolutionize the major CABG market with an restorative CABG Conduit
