Reflow Medical today announced it received FDA de novo clearance for its Spur Peripheral Retrievable Stent System for infrapopliteal arterial disease.
The system is cleared for use in de novo or restenotic lesions following predilatation in below-the-knee (BTK) vessels. It combines a self-expanding stent with an integrated balloon catheter on an over-the-wire delivery system and features radially expandable spikes that penetrate the lesion to increase luminal diameter and reduce vessel recoil. The company refers to the approach as Retrievable Scaffold Therapy (RST).
“Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur Stent System,” said Dr. Mahmood Razavi, director of clinical trials at St. Joseph Heart and Vascular Center and a lead investigator in the Deeper Reveal study. “This novel device will be a valuable and innovative expansion of our treatment toolbox as a unique device for the treatment of complex BTK disease.”
According to Reflow Medical, the 130-patient Deeper Reveal trial, conducted at 49 U.S. centers, demonstrated 99.2% technical success and 97.0% freedom from major adverse limb events (MALE) and perioperative death (POD) at 30 days.
“It’s exciting to see the clinical success of the Deeper Reveal trial enabling the De Novo clearance of the Spur Stent System,” said Dr. S. Jay Mathews, cath lab director at Bradenton Cardiology/Manatee Memorial Hospital. “This first-of-its-kind technology offers a truly novel approach to treating patients with BTK CLTI disease. As an adjunct to standard balloon angioplasty, Spur RST enables us to address this complex disease in a more effective way, achieving these outcomes that go beyond what PTA alone can deliver.”
Reflow Medical said it is preparing for commercial launch through its dedicated sales force.
