XeltisThe journal "CardioVascular and Thoracic Surgery (ICVTS)" published the 1-year patency data of Xeltis' regenerative artificial blood vessel XABG for the treatment of coronary heart disease.The data disclosed this time are not the complete clinical study results of FIM but a patient case from the FIM study. The patient is a 70-year-old male with a history of severe coronary atherosclerotic heart disease in all three coronary arteries and no suitable autologous great saphenous vein available. Preoperative assessment: Left anteriorDescending Branch（LAD）The QFR of the proximal lesion is 0.66,Left Circumflex Artery (The QFR for the proximal lesion of LCX is 0.92.Right Coronary Artery (RCA)The QFR of the proximal lesion is 0.76.RCA shows a good diameter (2.2 mm) in the target anastomosis area. The anastomosis, combined with severe proximal lesions, can minimize the risk of occlusion. Therefore, the surgical plan is to bypass LAD and RCA. It was decided to use the XABG graft for RCA.The surgical method is the same as traditional coronary artery bypass grafting, performed through open-heart surgery. Postoperative evaluations of patency rates are conducted at 6 months and 1 year.- The patient was discharged on the 7th day after surgery and received aspirin 150mg daily and ticagrelor 90mg.iDDual antiplatelet therapy, starting from the first day after surgery and lasting for 12 months;
- Angiography at 1 month and 6 months postoperativelyImaging shows the artificial blood vessel is patent (TIMI flow grade three);
- Cardiac computed tomography at 12 months postoperatively showed a patent graft, without signs of lumen irregularity or stenosis.
- During this period, the patient had noArtificial Blood Vessels RelatedComplications.
XeltisXeltis is currently the fastest progressing company in the field of artificial blood vessels for the treatment of coronary heart disease. Its product has completed FIM clinical enrollment and obtained partial clinical data. The preliminary results demonstrate the safety and efficacy of the regenerative artificial blood vessel XABG in treating coronary heart disease.BesidesXeltisExternalHumacyte and Medical 21 are also advancing the progress of artificial blood vessels for coronary artery bypass grafting. Among them,Humacyte has prepared to submit a clinical trial application to the FDA. However, due toHumacyte's products belong to biological products, so in terms of market launch, they will be compared with XABG andMMedical 21 products will be later. In terms of efficacy, all three lack effective clinical research data, and it will take a few years to see which technical route is better.
XABGIt is a restorative artificial blood vessel used for coronary artery bypass surgery, synthesized throughNovel supramolecular polymers throughArtificial blood vessels prepared by electrospinning process (with embedded nickel-titanium alloy stents), which can eventually be replaced by the patient's own tissue, made of absorbable materials.Its diameter is 4 mm, wall thickness is 500 µm, and length is 12 cm.XABGUsing porousDesign, allowing instant blood cell penetration. After implantation, theXABGAct ImmediatelyFunctional blood flow channels, as time goes by,XABGProvides a mechanical and structural scaffold for cell ingrowth driven by the body's natural healing process.
XABGPreviouslyCompletion of preclinical animal trials, with sheep as the animal model for this trial,PersonManufactureBlood VesselXABGIt is 15 cm long and has an inner diameter of 4 mm.One-Year Animal StudyData ShowXABGAfter implantationWithUnprecedented patency.Results from animal experiments showXABGInChallenging AnimalsModelTypeChinaMaintain Patency, no bridge vessel stenosis occurred one year after the surgery.Occlusion。
XABGAfter implantation, the polymer will gradually be replaced by the animal's own tissue. Due to the homogeneous endothelialization process, the entire...XABGThe inner surface shows a smooth and confluent or fully endothelialized lining. That is, the entire vascular graft is endothelialized.EndothelializationIt is the final stage of vascular healing, effectively preventing thrombosis and other negative side effects.
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 blood dialysis 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.
