Reflow Medical, Inc. announced that the first patients have been enrolled in its DEEPER OUS clinical trial using the Temporary Spur Stent System.
DEEPER OUS is a 100-patient prospective, non-randomized, multicenter trial designed to assess the safety and efficacy of the Temporary Spur Stent System compared to a meta-analysis of published data for percutaneous transluminal angioplasty (PTA) in treating patients with infrapopliteal disease.
Andrew Holden, MD, Director of Interventional Radiology at Auckland City Hospital in New Zealand was “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 often serious consequence of peripheral artery disease (PAD).
The Temporary Spur Stent System is a novel retrievable stent designed to treat severely calcified infrapopliteal disease by enhancing the uptake of anti-restenotic drugs and minimize vessel recoil without leaving anything behind.
“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,” commented Teo Jimenez, VP of Research and Development for Reflow Medical.
Reflow anticipates opening DEEPER OUS in European sites later this year and additional studies of next-generation Spur technologies in the near future.