Reflow Medical, Inc. announced that it has received FDA commercial clearance for its coraCatheters™, a complete line of state-of-the-art microcatheters engineered to access and cross complex and challenging lesions in percutaneous coronary interventions.
The coraCatheters family of novel devices is the latest in the Reflow portfolio, which includes the Wingman™ and Spex™ Catheters. As the company makes its mark in the coronary space, they are expanding their sales team to support both current and future innovations.
The coraCatheters line includes the coraFlex™ microcatheter with an integrated flexible polymer tip for precise navigation of tortuous anatomies, plus optimal guidewire movement and support. The coraForce™ is the first microcatheter for treating coronary disease to feature a metallic tip, which maximizes tip force with minimal tip fatigue and provides extra pushability and support, while maintaining a low profile throughout. The coraCross™ Crossing device employs Reflow’s patented bevel-extension technology, adapted specifically for penetrating heavily calcified caps. Featuring three to four times the tip force of other polymer catheters, the device can be activated and advanced to achieve excellent penetration and trackability.
“It’s exciting to see a company do the work it takes to produce innovative devices in the coronary space,” said 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. “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 said.
Dr. Lombardi provided clinical experience for developing the new catheters, along with Medical Center colleagues Lorenzo Azzalini, MD, PhD, MSc, FACC, FSCAI, Director of Interventional Cardiology Research and Associate Professor of Medicine, and Interventional Cardiologist Kathleen Kearney, MD, FSCAI.
“We’ve experienced outstanding bilateral torque control with coraCatheters,” said Dr. Azzalini. “It can be a game changer for successfully treating severely calcified lesions.”
Reflow developed a specific new technology called coraTech™ to produce the innovative catheters, which feature the lowest profile available. A robust, multilayer body design that accommodates different tips, coraTech promotes superior lumen integrity and kink resistance, with extreme support while tracking through tortuous anatomies. The absence of an inner liner also promotes superior torque response.