New-look peripheral stent with expandable spikes receives FDA’s de novo classification
Reflow Medical, a California-based medtech company focused on cardiovascular disease treatments, has received the FDA’s de novo classification for its Spur Peripheral Retrievable Stent System.
De novo classification represents an alternative pathway to gaining FDA approval when no comparable devices are currently available. Once a medical device has been granted this classification, it can be marketed in the United States. It can also be used as a comparison in the future when other devices are being considered for approval.
The Spur Peripheral Retrievable Stent System was designed to treat de novo or restenotic lesions in the peripheral arteries following predilatation in patients with infrapopliteal arterial disease. According to Reflow Medical, this is the first retrievable stent system that includes a self-expandable stent in addition to an integrated dilatation balloon catheter on an over-the-wire system. It features a series of expandable spikes that penetrate the lesion in question to increase its acute luminal diameter and modify its morphology.
The DEEPER REVEAL clinical trial, funded by Reflow Medical, examined the Spur Stent System’s safety and effectiveness in 130 patients. Overall, below-the-knee (BTK) treatment of chronic limb-threatening ischemia (CLTI) with the device following predilatation was associated with a 99.2% technical success rate and freedom from major adverse limb events and perioperative death at 30 days in 97% of patients.
“Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur Stent System,” DEEPER REVEAL co-principal investigator Mahmood K. Razavi, MD, director of the Clinical Trials and Research Center at St. Joseph Heart and Vascular Center, said in a statement. “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.”
“It’s exciting to see the clinical success of the DEEPER REVEAL trial enabling the de novo clearance of the Spur Stent System,” added DEEPER REVEAL co-principal investigator S. Jay Mathews, MD, MS, the 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 Retrievable Scaffold Therapy enables us to address this complex disease in a more effective way, achieving these outcomes that go beyond what percutaneous transluminal angioplasty alone can deliver.”
Isa Rizk, Reflow Medical CEO and co-founder, celebrated the FDA’s decision in the same statement.
“We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients,” he said.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.