Reflow Medical’s Spur Stent System Receives FDA De Novo Clearance for Below-the-Knee Arterial Disease

Reflow Medical, Inc., a company specialising in innovative medical technologies for complex cardiovascular conditions, has received De Novo clearance from the U.S. Food and Drug Administration for its Spur Peripheral Retrievable Stent System. 

The system is intended for the treatment of de novo or restenotic lesions in patients with infrapopliteal arterial disease, following vessel preparation through predilatation.

It features a self-expanding stent combined with a balloon catheter on an over-the-wire platform. The system is designed to penetrate lesions using expandable spikes, increasing vessel diameter and improving compliance. 

This technology, known as Retrievable Scaffold Therapy (RST), also helps reduce the chance of the vessel narrowing again (recoil).
Clinical results from the DEEPER REVEAL study (NCT05358353), which evaluated the system for treating chronic limb-threatening ischaemia (CLTI) in below-the-knee (BTK) arteries, showed promising outcomes. 

The study was carried out across 49 medical centres in the United States and included 130 patients. Experienced investigators led it in vascular and interventional cardiology.

Reflow Medical highlighted the role of long-term research and development efforts in the creation of this novel device. 

The technology was developed specifically to enhance lesion penetration and improve outcomes in patients with BTK peripheral arterial disease.

With FDA clearance now granted, the company plans to make the Spur Stent System available through its dedicated sales team to support healthcare providers in treating patients with CLTI.