FDA Greenlights Reflow Medical's Innovative Retrievable Stent System for Below-the-Knee Treatments

In a significant development for the treatment of peripheral artery disease, Reflow Medical has secured FDA clearance for its novel retrievable stent system designed to improve blood flow in the lower limbs. The Spur implant, a self-expanding bare-metal stent featuring small spikes to penetrate calcifications within blood vessels, represents a breakthrough in addressing infrapopliteal arterial disease without leaving behind permanent implants.

Groundbreaking Technology and Clinical Success

The Spur stent system's unique design allows it to be used up to four times in a single procedure, making it particularly suitable for treating long lesions. Its innovative approach involves temporarily expanding blocked arteries while reducing the effects of recoil once removed. This method has shown promising results in clinical trials, with a 99.2% successful placement and opening rate following balloon dilation.

Clinical data supporting the FDA's de novo clearance demonstrated impressive short-term outcomes. After 30 days, 97.0% of patients treated with the Spur system reported no major adverse limb events, including amputations or perioperative deaths. These results highlight the potential of this technology to significantly improve outcomes for patients with chronic, limb-threatening ischemia.

Global Expansion and Future Developments

Reflow Medical's CEO, Isa Rizk, expressed readiness to launch the technology through their dedicated sales force, emphasizing the company's commitment to promptly delivering this innovative solution to physicians and patients. The FDA clearance follows the device's CE Mark approval in January 2024, signaling Reflow Medical's expanding global presence.

To further solidify its European market position, the company recently established a subsidiary in Germany. This strategic move aims to develop direct sales channels and distribution partnerships across the continent, potentially accelerating the adoption of the Spur system in European healthcare settings.

Expanding Applications and Ongoing Research

While the current FDA clearance focuses on below-the-knee applications, Reflow Medical is not resting on its laurels. The company is actively developing a drug-eluting version of the Spur designed for use in coronary arteries. This ongoing research underscores the potential for this technology to address a broader range of vascular conditions and further revolutionize minimally invasive treatments for arterial disease.