Clinical News

Xeltis starts pivotal clinical trial of “first-ever” restorative synthetic haemodialysis access graft

Xeltis announced today the initiation of a pivotal trial with the “first-ever” restorative synthetic haemodialysis access graft, dubbed ‘Axess’.

The first two patients have been successfully implanted as part of the AXESS European pivotal trial at AZ Sint-Jan Brugge-Oostende AV (Bruges, Belgium) by vascular surgeon Jan de Letter, and discharged from hospital.

The AXESS EU pivotal trial is a prospective, single-arm study to evaluate the safety and performance of Axess in patients with end-stage kidney disease who need haemodialysis. The study will enrol 110 patients at up to 25 centres in Europe and will follow them for five years.

The Axess graft has been previously successfully implanted in 20 patients, as part of the AXESS first-in-human (FIH) trial, which completed enrolment in September 2022. AXESS FIH full cohort data are expected in 2023.

“A device that enables immediate use, as seen with the existing synthetic ePTFE [expanded polytetrafluoroethylene] grafts, and turns into a living blood vessel that recovers promptly after puncturing from each dialysis session may become the safer and longer-lasting solution that patients on haemodialysis need,” explained De Letter, who also has previous experience with Axess, having implanted it during the FIH trial.

“We are encouraged by the promising preliminary experience with this device from the FIH trial, and confirmation in a larger trial involving more patients and implanting sites is an important next step.”

The Axess graft is a restorative, synthetic, electrospun blood vessel for arteriovenous haemodialysis access. Once implanted, its porous microstructure gets colonised by the patient’s own tissue cells through the body’s natural healing process, turning into a living vessel made of their own tissue over time.

“Life for patients on haemodialysis means multiple hospital visits each week, involving puncturing, bleeding, waiting, healing and risk of infections from all of the above, in addition to poor renal function,” added An de Vriese, head of Nephrology and Infectious Diseases at AZ Sint-Jan Brugge-Oostende AV, and one of the co-ordinating investigators of the AXESS EU pivotal trial. “If a novel device can spare part of this burden through reduced bleeding, prompt coagulation and healing, lower infection risks and longer durability, it would be a life-changing experience for most patients.”

ReCor Medical announces consistent reduction of blood pressure in pooled analysis of three clinical trials

ReCor Medical and its parent company, Otsuka Medical Devices, announced consistent and significant blood pressure-lowering results across a range of patients with uncontrolled hypertension, including across differences in age, sex, baseline blood pressure, medication level and ethnicity. The results come from analysis of the pooled data from ReCor’s RADIANCE global clinical trial programme: three prospectively powered, randomised and sham-controlled clinical trials which evaluated the endovascular Paradise ultrasound renal denervation (uRDN) system in patients with uncontrolled hypertension.

The RADIANCE pooled analysis includes data from more than 500 patients randomised in the three studies from ReCor’s RADIANCE global programme: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-to-moderate hypertension. The combined dataset showed an overall reduction in daytime ambulatory systolic blood pressure in the uRDN group of -8.5mmHg (p<0.0001) with a difference between treatment and sham at two months of -5.9mmHg (p<0.0001), favouring uRDN. Blood pressure results were similarly positive in the 24-hour, nighttime, home, and office measures. A favourable safety profile was consistently observed following uRDN treatment across the studies.

“Pooling the data from the RADIANCE programme demonstrates that treatment with the Paradise uRDN System results in a consistent reduction in blood pressure across differing severities of hypertension.

The consistent and clinically meaningful blood pressure reduction across multiple patient groups increases our interest in the use of uRDN as a potential therapeutic option, when added to lifestyle modification and medications for our patients with uncontrolled blood pressure,” said Ajay Kirtane (Columbia University Irving Medical Center, New York USA), study co-principal investigator.