FDA Clears Reflow Medical's Innovative Retrievable Stent System for Below-the-Knee Treatment

Reflow Medical has achieved a significant milestone with the FDA's de novo clearance of its novel retrievable stent system, designed to improve blood flow in blocked arteries below the knee while leaving no permanent implant behind. This groundbreaking device offers new hope for patients suffering from infrapopliteal arterial disease and chronic limb-threatening ischemia.

The Spur Stent System: A Breakthrough in Vascular Intervention

The Spur implant, developed by Reflow Medical, features a unique design with small spikes that penetrate calcifications within peripheral blood vessels. This innovative approach helps reduce the effects of recoil once the stent is removed from the artery, potentially improving long-term outcomes for patients with long lesions.

Key features of the Spur stent system include:

• Retrievability, allowing for multiple uses (up to four times) during a single procedure
• Self-expanding, bare-metal construction
• Ability to treat long lesions in below-the-knee arteries

Clinical Success and Patient Outcomes

The FDA's clearance follows a successful clinical trial focusing on patients receiving below-the-knee treatments for chronic, limb-threatening ischemia. The trial demonstrated impressive results:

• 99.2% successful placement and opening rate after balloon dilation
• 97.0% of patients reported no major adverse limb events (such as amputations) or perioperative deaths after 30 days

These outcomes highlight the potential of the Spur system to significantly improve patient care in the treatment of peripheral artery disease.

Global Expansion and Future Developments

Reflow Medical is poised for rapid deployment of its new technology. CEO Isa Rizk stated, "We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients."

The company has already made strides in the European market:

• Establishment of a European subsidiary in Germany for direct sales and distribution partnerships
• CE Mark approval for the Spur system obtained in January 2024

Additionally, Reflow Medical is developing a drug-eluting version of the Spur designed for use in coronary arteries, further expanding its potential applications in vascular intervention.