Reflow Medical has received De Novo clearance from the US Food and Drug Administration (FDA) for its Spur Peripheral Retrievable Stent System.
The system is designed to treat de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease.
The Spur Stent System is distinct as it is the only retrievable stent system that includes a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system.
It utilises a series of radially expandable spikes for controlled lesion penetration and treatment, a method known as Retrievable Scaffold Therapy (RST).
These spikes aim to increase the acute luminal diameter and modify lesion morphology, thereby altering vessel compliance and reducing vessel recoil effect, said the company.
The DEEPER REVEAL clinical trial, registered under NCT05358353, evaluated the Spur Stent System for below-the-knee (BTK) treatment of chronic limb-threatening ischemia (CLTI). Conducted across 49 centres in the US, the trial enrolled 130 patients.
Results indicated a 99.2% technical success rate and a 97.0% freedom from Major Adverse Limb Events (MALE) and Perioperative Death (POD) at 30 days post-procedure.
St. Joseph Heart and Vascular Center clinical trials and research centre director Mahmood Razavi said: “Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur Stent System.
“This novel device will be a valuable and innovative expansion of our treatment toolbox as a unique device for the treatment of complex BTK disease.”
Bradenton Cardiology/Manatee Memorial Hospital Cath Lab director S Jay Mathews said: “It’s exciting to see the clinical success of the DEEPER REVEAL trial enabling the De Novo clearance of the Spur Stent System.
“This first-of-its-kind technology offers a truly novel approach to treating patients with BTK CLTI disease.
“As an adjunct to standard balloon angioplasty, Spur RST enables us to address this complex disease in a more effective way, achieving these outcomes that go beyond what PTA alone can deliver.”
Dr Mathews and Dr Razavi served as lead principal investigators for the study.
In March this year, Reflow Medical announced the establishment of its European subsidiary in Landsberg am Lech, Germany. The expansion aims to bolster the company’s ability to serve markets beyond the US.
