Reflow Medical’s coraCatheters Line Gains FDA Nod

Reflow Medical has earned U.S. Food and Drug Administration (FDA) clearance for its coraCatheters line of microcatheters to access and cross complex, challenging lesions in percutaneous coronary interventions.
 
The coraCatheters line include the coraFlex microcatheter with integrated flexible polymer tip to precisely navigate tortuous anatomies, as well as optimal guidewire movement and support. According to Reflow, coraForce is the first microcatheter for treating coronary disease to feature a metallic tip—which minimize tip force with minimal tip fatigue and offers extra pushability and support—while maintaining a low profile.
 
The coraCross crossing device uses Reflow’s bevel-extension tech adapted specifically for penetrating heavily calcified caps. It features three to four times the tip force of other polymer catheters and can be activated and advanced to achieve penetration and trackability.
 
“It’s exciting to see a company do the work it takes to produce innovative devices in the coronary space,” William Lombardi, MD, FACC, FSCAI, who is a Clinical Professor and Director of Complex Coronary Artery Disease Therapies at the University of Washington Medical Center, and a globally recognized specialist in complex coronary PCI, told the press. “After Reflow came to us, there was no stopping until we got it right.”
 
Jay Mathews, MD, MS, FACC, Cath Lab Director at Manatee Memorial Hospital in Bradenton, Florida, was involved in every stage of clinical development. “The coraCatheters devices are the next generation in PCI care. They can also be effectively used to treat critical limb ischemia,” he added.
 
The company produced a new technology called coraTech to produce the catheters. A robust, multilayer body design that accommodates different tips, coraTech promotes better lumen integrity and kink resistance, with extreme support while tracking through tortuous anatomies. The absence of an inner liner also promotes better torque response, according to Reflow.