Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon

Evaluation of the Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon Catheters in Peripheral Arteries

This is a 'first in man' study to demonstrate compliance with the general safety and performance requirements of Regulation (EU) 2017/745 on medical devices (MDR) Annex I as part of the clinical evaluation and for the application of CE-marking. The aim of the study is to evaluate the safety and tolerability of the application and the success rate of the InnoCath AB® hyper-compliant balloon catheter after PTA in peripheral arteries.

Inclusion Criteria:

• 18 years of age
• Patients with peripheral arterial occlusive disease and intended for endovascular therapy in the SFA and/or popliteal artery pars I/II
• Patients suitable for endovascular therapy in the SFA and/or popliteal artery pars I/II with a hyper-compliant balloon without further luminal widening
• Target vessels with a sufficient "runoff" to the foot with at least one vessel
• Rutherford classification 1-4 if physical and medicinal therapies have not been successful

Exclusion Criteria:

• Aneurysms at the site of inflation
• Application directly in the area of large vessel wall injuries with heavy bleeding
• Rutherford classification 5 and 6