Cardionovum GmbH has announced that it 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 highly promising and significant first clinical evidence for APERTO.
Regardless of whether it is created as an arterio-venous fistula (AVF) or as a shunt graft, hemodialysis shunt patency is threatened by restenosis, which is the number-one cause of hemodialysis shunt failure and a dreaded 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. 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 hemodialysis shunt patency.
Hemodialysis shunt stenosis treatment with Cardionovum's novel APERTO paclitaxel-releasing, high-pressure balloon dilatation catheter adds an unparalleled 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 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, MD, Principal Study Investigator at the National Vascular Hospital, Belfast, Ireland.
The drug paclitaxel, along with the highly effective novel "INTENSE" drug release composition on the APERTO balloon surface, cannot be compared with any of the conventional DCB drug coatings that are marketed, for example, for treating peripheral artery lesions. APERTO's "INTENSE" drug coating is designed for the treatment of the complex restenotic and scarred hemodialysis 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 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 APERTO DCB have shown that the negative cycle of repeated, purely mechanical shunt treatments are reduced significantly by the pro-healing effect of APERTO DCB.
"Cardionovum is focused on developments of truly innovative cardiovascular medical devices: specifically, next-generation, drug-releasing balloon and stent technologies. APERTO follows our commercialization of peripheral and coronary DCB devices LEGFLOW® and RESTORE®, which represent another novel third-generation DCB technology, SAFEPAX," said Michael Orlowski, MD, CEO.
About APERTO®
APERTO® is the first paclitaxel-releasing, high-pressure shunt balloon dilatation catheter for the treatment of stenosis and prolonged prevention of stenosis in hemodialysis shunts.