Reflow Medical has started the DEEPER OUS clinical trial, which is designed to evaluate the Temporary Spur Stent System.
DEEPER OUS is a 100-patient prospective, non-randomised and multicentre trial that will assess the safety and efficacy of the Temporary Spur Stent System compared against meta-analysis of published data for percutaneous transluminal angioplasty (PTA) in treating patients with infrapopliteal disease.
New Zealand’s Auckland City Hospital interventional radiology director Dr Andrew Holden said: “delighted to perform the first three cases treating BTK PAD using the Temporary Spur Stent System.
“All three cases were technically successful and all patients were discharged home safely the following day, with an excellent clinical result. We look forward to gaining more experience with this new technology as the trial continues.”
Occlusive disease affecting below-the-knee (BTK) arteries is a common and serious event of peripheral artery disease (PAD).
Reflow’s Temporary Spur Stent System
Reflow’s Temporary Spur Stent System is a novel retrievable stent designed for the treatment of severely calcified infrapopliteal disease by improving the uptake of anti-restenotic drugs and. It also minimises vessel recoil without leaving anything behind.
According to the company, the Temporary Spur Stent System is an investigational device only and is not yet secured approval for commercial sale.
Reflow Medical research and development vice president Teo Jimenez said: “This milestone demonstrates our commitment to collecting verifiable clinical data in developing innovative technology like the Spur Stent System.
“Guided by real data, the team at Reflow Medical, along with our world-class physician partners, continues to address the unmet needs of patients with peripheral vascular disease.”
Reflow is planning to launch DEEPER OUS trial in European sites later this year, as well as additional studies of next-generation Spur technologies in the near future.
Reflow Medical is engaged in the designing and development of advanced and effective technologies for cardiovascular disease.
The company is currently developing a family of products for the treatment of cardiovascular disease. – NS Medical Devices