This multi-center, prospective, randomized, clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of the SelfWrap, a bioabsorbable perivascular wrap, for supporting surgically-created AVFs and using them for dialysis.

This study will involve approximately 200 participants. Half of the subjects in this trial will receive AVFs supported by the SelfWrap, while the other half will receive a traditional AVF alone. Participants will be followed for a duration of 36 months.

This research study is a prospective registry trial designed to evaluate the efficacy and safety of a novel decellularized human femoral artery allograft (Nexeon AVX) in the creation of vascular access for hemodialysis in patients with end stage renal disease (ESRD). Data from clinic visits will be collected for up to 2 years after treatment begins.

This research study is a prospective registry trial designed to evaluate the efficacy and safety of a novel decellularized human femoral artery allograft (Nexeon AVX) in the creation of vascular access for hemodialysis in patients with end stage renal disease (ESRD). Data from clinic visits will be collected for up to 2 years after treatment begins.

The InnAVasc Arteriovenous Graft is made from the same materials as standard care grafts, but with added medically safe materials that may make the graft easier to identify, safer to stick for dialysis, more durable, and less likely to bleed after your dialysis session when compared to standard care grafts. The InnAVasc Arteriovenous Graft is an investigational product, which means that this is not yet approved by government agencies like the U.S. Food and Drug Administration (FDA), but preliminary tests in the laboratory and in animals have proven safe enough to be allowed to be used in human clinical studies such as this.

Approximately 105 subjects will take part in this research at approximately 30 different medical facilities/hospitals in the United States. This will be the third time (3rd study) the InnAVasc Arteriovenous Graft will be used in human subjects.

The InnAVasc Arteriovenous Graft is made from the same materials as standard care grafts, but with added medically safe materials that may make the graft easier to identify, safer to stick for dialysis, more durable, and less likely to bleed after your dialysis session when compared to standard care grafts. The InnAVasc Arteriovenous Graft is an investigational product, which means that this is not yet approved by government agencies like the U.S. Food and Drug Administration (FDA), but preliminary tests in the laboratory and in animals have proven safe enough to be allowed to be used in human clinical studies such as this.

Approximately 105 subjects will take part in this research at approximately 30 different medical facilities/hospitals in the United States. This will be the third time (3rd study) the InnAVasc Arteriovenous Graft will be used in human subjects.

This is a prospective, multi-center, two-arm, randomized clinical trial for Stage 5 Chronic Kidney Disease (CKD5) or End Stage Renal Disease (ESRD) patients who are undergoing fistula creation for hemodialysis in order to evaluate the safety and effectiveness of the EchoMark® ultrasound marker and the EchoSure® AVF Diagnostic System for assessing fistula maturation and reducing time to Clinical Maturation when used under a biweekly protocol as compared to the standard of care follow-up.

The EchoMark is a small device that is implanted in the soft tissue near the site where the fistula is created and can measure the fistula blood flow, diameter, and depth. The device can be easily seen by EchoSure, the ultrasound equipment which can provide measurements and information about blood flow and vessel diameter and depth.

This study will involve approximately 304 participants. Half of the subjects in this trial will receive the EchoMark implant, while the other half will receive traditional fistula creation. Participants will be followed for a duration of 12 months.

Patients with End Stage Renal Disease (ESRD) need hemodialysis at least three times a week, with each session lasting up to four hours. This frequent access can cause complications like infiltration, vessel wall weakening, and vein failure. The VenaSure aims to improve this by implanting a device that reduces the need for many punctures and protects the vessel walls, extending the life of the access vein. This helps patients continue their daily lives with fewer disruptions while receiving dialysis. About 100 participants will be enrolled study-wide, with 20 at MUSC Orangeburg. Participants will be followed for 36 months.

This is a multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon. The alternative option is called an arterio-venous graft (AVG), where the doctor implants a synthetic/artificial tube under the patient's skin, where one end of the tube connects to a vein and the other to an artery. This tube is then used as the ‘access site' during hemodialysis. Participants with ESRD in need of vascular access, and who agree to be in this study, and also meet all the eligibility criteria for participation, will receive the Xeltis aXess graft, a type of AVG as previously described.