Reflow Medical has secured a groundbreaking green light from the FDA for its retrievable stent system, designed to boost blood flow through blockages in the lower limbs while leaving nothing behind.
The company’s Spur implant carries a series of small spikes that penetrate calcifications from within the peripheral blood vessel, to help reduce the effects of recoil once the stent is removed from the artery. The device is designed to help treat long lesions, and can be used up to four times.
The agency’s de novo clearance in infrapopliteal arterial disease followed a successful clinical trial of patients who received below-the-knee treatments for chronic, limb-threatening ischemia.
The company said that after undergoing balloon dilation, the Spur self-expanding, bare-metal system saw a 99.2% successful placement and opening rate. After 30 days, 97.0% of patients reported no major adverse limb events, such as amputations, or perioperative deaths.
“We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients,” Reflow Medical’s co-founder and CEO, Isa Rizk, said in a statement.
Earlier this year, Reflow Medical opened a European subsidiary in Germany, tasked with establishing direct sales channels and distribution partnerships on the continent. The company received a CE Mark approval for the Spur in January 2024.
The company has also been developing a drug-eluting version of the Spur designed for use in the heart’s coronary arteries.