The first peripheral arterial disease (PAD) patient with disease in the superficial femoral and popliteal arteries has been successfully enrolled in the FORTEZ study. The single centre, single-arm non-randomised, prospective study will investigate the treatment of atherosclerotic lesions in the superficial femoral and/or popliteal arteries using the FLEX dynamic scoring catheter (VentureMed Group) plus drug-coated balloon (DCB).
The FORTEZ study is being conducted at the St Joseph Hospital in Fort Wayne, USA. The objective of the study is to assess safety and efficacy of the FLEX catheter in patients with atherosclerotic peripheral artery disease in the superficial femoral and popliteal arteries.
The FLEX catheter creates long parallel linear micro incisions in all plaque morphologies to prepare the vessel environment to facilitate angioplasty. Its dynamic technique safely scores difficult, diseased vessels, providing vessel compliance and acute lumen gain, a press release states.
“There are an increasing number of cases where vessel preparation before drug-coated balloon angioplasty is necessary to deliver the best outcomes. The FLEX catheter is showing potential to change the current practices,” says Lou Lopez, director Cardiac Catheterization Lab, Allen County Cardiology, St Joseph Hospital. Lopez adds, “We are excited to be part of the FORTEZ study and look forward to validating the many possible benefits of this potential clinical advancement.”