Reflow Medical Earns De Novo OK for Spur Peripheral Retrievable Stent

Reflow Medical has received De Novo clearance from the U.S. Food and Drug Administration (FDA) for its Spur peripheral retrievable stent system.

Spur is used to treat de novo or restenotic lesions after predilatation in patients with infrapopliteal arterial disease. According to the company, it’s the first, only retrievable stent with an integrated dilatation balloon catheter on an over-the-wire system.

The strent system was designed for controlled lesion penetration and treatment via a series of radially expandable spikes. The treatment is referred to as retrievable scaffold therapy (RST), in which the spikes on the Spur stent penetrate the lesion to increase acute luminal diameter and modify lesion morphology to change vessel compliance and minimize vessel recoil effect.

The recently finished DEEPER REVEAL trial evaluating Spur for below-the-knee (BTK) treatment of chronic limb-threatening ischemia (CLTI) showed that after predilatation, the Spur stent system had a 99.2% technical success rate and 97% freedom from major adverse limb events and perioperative death at 30 days.

“Extensive research and development, which laid the groundwork for the DEEPER REVEAL trial, enabled the creation and clinical validation of the Spur Stent System, an innovative mechanical endovascular device engineered to enhance lesion penetration and optimize the treatment of BTK peripheral arterial disease,” said Reflow Medical’s senior VP of R&D Teo Jimenez.

The study was conducted at 49 U.S. centers, enrolling 130 patients.

“The FDA’s De Novo clearance, following positive clinical trial results in patients with CLTI, enables us to provide physicians with an effective therapeutic option for this growing patient population,” said Reflow Medical co-founder and CEO Isa Rizk. “We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients.”

In March, the company opened a European subsidiary in Landsberg am Lech, Germany.