Reflow Medical’s Spur Peripheral Retrievable Stent System Receives the US FDA’s De Novo Clearance for BTK-CLTI Treatment

Shots:

• FDA has granted De Novo clearance to the Spur Stent System for treating de novo or restenotic lesions post-predilatation in pts with infrapopliteal arterial disease
• In recently concluded DEEPER REVEAL trial (n=130), the system achieved 99.2% technical success rate & 97% freedom from MALE & POD at 30 days post-predilatation for below-the-knee (BTK) treatment in pts with chronic limb-threatening ischemia (CTLI)
• Spur Stent System is an over-the-wire, self-expanding stent system with an integrated balloon catheter, designed to treat lesions using retrievable scaffold therapy that penetrates the lesion to enlarge luminal diameter, modify morphology, improve vessel compliance, & reduce recoil effect

Ref:  Businesswire| Image:  Reflow Medical| Press Release

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