Restorative Cardiovascular Devices
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With ETR, the patient’s natural healing system develops tissue that pervades Xeltis’ device, forming a new, natural and fully functional blood vessel or heart valve within it.
As ETR occurs, Xeltis implants are gradually absorbed by the body.
ETR is enabled by the porous structure of Xeltis’ devices, which are made of bioabsorbable polymers, based on Nobel-prize awarded science.
Heart Valve Replacement
Xeltis’ solution: Xeltis restorative heart valves may offer long-term durability and growth potential, as they enable the body to develop new heart valves with patients own tissue.
Patients: Hundreds of thousands of patients undertake heart valve intervention every year.1
Current standard of care: biological (animal-derived), mechanical heart valves or from human donors.
Current limitations: Patients with biological valves may endure repeated replacement procedures as most devices are short lived. Mechanical heart valves require life-long anticoagulation treatment, with potentially severe side effects. Human heart valves are in scarce supply and fully synthetic heart valves are currently not available.
[1] Benjamin EJ, et al. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492
Coronary Artery Bypass Graft (CABG)
Xeltis’ solution: Xeltis restorative CABG offers a true alternative to vein harvesting. It enables the body to develop a new blood vessel to potentially reduce complications and overall healthcare costs.
Patients: Around 1 million patients undergo CABG surgery each year.
Current standard of care: CABG surgery is the gold standard for coronary artery disease treatment caused by multiple blood vessel occlusion/narrowing.1,2,3,4,5,6
It is normally performed by harvesting patient’s own veins,7 an additional surgery that may lead to pain and infections.8,9 Synthetic grafts are currently not available.
Current limitations: On average, around 20 percent of veins occlude by the end of the first year after CABG surgery.6
[1] Benjamin EJ, et al. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492
[2] Benedetto U, et al. Coronary surgery is superior to drug eluting stents in multivessel disease. Systematic review and meta-analysis of contemporary randomized controlled trials. Int J Cardiol 2016;210:19–24.
[3] Mohr FW, et al. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013 Feb 23;381(9867):629-38
[4] Mäkikallio T, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting n treatment of unprotected left main stenosis (NOBLE), a prospective , randomised, open label, non inferiority trial. Lancet 2016, October 31. S0140-6736(16)32052-9
[5] Taggart DP, et al, A prospective study of external stenting of saphenous vein grafts to the right coronary artery: the VEST II study. European Journal of Cardio-Thoracic Surgery 0 (2017) 1–7
[6] Shavadia J. Symptomatic graft failure and impact on clinical outcome after coronary artery bypass grafting surgery: Results from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry. Am Heart J. 2015 Jun;169(6):833-40.
[7] Tabata M, et al. Prevalence and variability of internal mammary artery graft use in contemporary multivessel coronary artery bypass graft surgery: analysis of the society of thoracic surgeons national cardiac database. Circulation, 2009;120:935–40.
[8]. Crouch, J. D. et al. Open versus endoscopic saphenous vein harvesting: Wound complications and vein quality. in Annals of Thoracic Surgery (1999). doi:10.1016/S0003-4975(99)00947-9
[9]. Allen, K. B. et al. Influence of endoscopic versus traditional saphenectomy on event-free survival: five-year follow-up of a prospective randomized trial. Heart Surg Forum (2003). doi:10.1532/hsf.1020
Hemodialysis Vascular Access
Xeltis’ solution: Xeltis’ vascular access graft combines the best of both worlds – a potentially longer lasting and readily available vascular access of suitable dialysis size turned into a living, natural graft made of patient’s own tissue.
Patients: 3 million patients need hemodialysis each year for which they require vascular access to connect to the dialysis machine.
Current standard of care: an arteriovenous (AV) fistula: a patient vein gets enlarged through surgical connection to an artery, requiring weeks or months to mature to the right size; synthetic AV graft (AVG) connecting vein to the artery or temporary synthetic catheter.
Current Limitations: 60 percent of fistulas fail to mature within 6 months or take longer to heal. AVG have poor performance, as the fail early and need repeated interventions, which drive morbidity, costs and low quality of life.
