Cardionovum has initiated a 150-patient clinical study of its novel paclitaxel-releasing, high-pressure shunt balloon dilatation catheter, Aperto. The study aims to sustain the first clinical evidence for Aperto.
Regardless of whether it is created as an arterio-venous fistula or as a shunt graft, haemodialysis shunt patency is threatened by restenosis, which is the number-one cause of haemodialysis shunt failure and a complication in the treatment of haemodialysis-dependent, end-stage renal disease patients. Short-cutting the arterial and venous vascular system to create a haemodialysis shunt results in haemodynamic pressure and blood flow gradients that are crucial to enable haemodialysis but which induce as a downside the formation of neo-intimal hyperplasia and stenosis. As the patency of the shunt is essential for the survival of the patients, the suppression of neo-intimal hyperplasia is the logical way to lower the frequency of the necessary shunt interventions and prolong overall haemodialysis shunt patency.
According to a company press release, haemodialysis shunt stenosis treatment with Cardionovum’s Aperto paclitaxel-releasing, high-pressure balloon dilatation catheter adds an anti-inflammatory and anti-proliferative therapeutic effect to the conventional, purely mechanical angioplasty procedure, which — despite being ineffective in restenosis prevention — is currently widely used to treat haemodialysis vessel stenosis.
“The application of Aperto promises a substantial reduction of haemodialysis shunt restenosis for a prolonged dialysis access survival. This means less shunt re-interventions for a better patient life quality,” says William Loan, principal study investigator at the National Vascular Hospital, Belfast, UK.
Aperto’s “INTENSE” drug coating is designed for the treatment of the complex restenotic and scarred haemodialysis shunt tissue and prolongs significantly the interval until the unavoidable re-intervention. It has the potential to fully replace the conventional, purely mechanical angioplasty procedure, whose mode of action catalyses excessive mechanical stress with consecutive disruption of the vessel intima and media, as well as tension on the adventitia. The purely mechanical, and traumatic, treatment triggers the migration and proliferation of fibroblasts, myofibroblasts, smooth muscle cells and further contributes to the development of consecutive neo-intimal hyperplasia.
Early clinical data with Aperto have shown that the negative cycle of repeated, purely mechanical shunt treatments are reduced significantly by the pro-healing effect of the drug-coated balloon.