Cardionovum Begins Clinical Study of Aperto Drug Coated Balloon

Cardionovum GmbH has begun a 150-patient clinical study of its paclitaxel-releasing, high-pressure shunt balloon dilatation catheter, Aperto. The study aims to sustain the first clinical evidence for the product.

Regardless of whether it is created as an arterio-venous fistula or as a shunt graft, hemodialysis shunt patency is threatened by restenosis — the number-one cause of hemodialysis shunt failure and a complication in the treatment of hemodialysis-dependent, end-stage renal disease patients. Short-cutting the arterial and venous vascular system to create a hemodialysis shunt results in hemodynamic pressure and blood flow gradients that are crucial to enable hemodialysis but which induce as a downside the formation of neo-intimal hyperplasia and stenosis. Experts believe the suppression of neo-intimal hyperplasia is a logical way to lower the frequency of necessary shunt interventions and prolong overall hemodialysis shunt patency.

Hemodialysis shunt stenosis treatment with Cardionovum’s novel 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 hemodialysis vessel stenosis, the company claims in a news release.

“The application of Aperto promises a substantial reduction of hemodialysis shunt restenosis for a prolonged dialysis access survival. This means less shunt re-interventions for a better patient life quality,” said William Loan, M.D., principal study investigator at the National Vascular Hospital in Belfast, Ireland.

Aperto’s drug coating is designed to treat the complex restenotic and scarred hemodialysis shunt tissue. Cardionovum bigwigs believe it has the potential to replace the conventional, purely mechanical angioplasty procedure, whose mode of action catalyzes 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 the Aperto drug-coated balloon (DCB) have shown that the negative cycle of repeated, purely mechanical shunt treatments are reduced significantly.

“Aperto follows our commercialization of peripheral and coronary DCB devices Legflow and Restor, which represent third-generation DCB technology, Safepax,” said Michael Orlowski, M.D., Cardionovum’s CEO.