Cook Medical said today that it’s Evolution RL and Evolution Shortie RL cardiac lead extraction devices are back on the U.S. market after a 2-month suspension prompted by an FDA warning issued last April.
The FDA had accused the Bloomington, Ind.-based medical device company of selling an unapproved device in the U.S., saying changes made to the Evolution devices required Cook Vascular to file a new clearance application with the federal watchdog agency.
The FDA said a review of Cook’s website and a promotional brochure for the Evolution Shortie RL, an iteration of the Evolution RL device that won 510(k) clearance in 2006, "provides evidence that the device has undergone design changes including what appears to be an extension to the Evolution line and material changes to the sheath since the device was cleared."
"As described in the promotional materials on your firm’s website and in a product brochure, these changes represent major changes or modifications to the intended use of your firm’s device," according to the April 25 warning letter, which was released May 5 – neatly coinciding with The FDA warning letter coincides with Cook Medical’s celebration of the 25th anniversary of the invention of cardiac lead extraction technology.
"For a quarter century, Cook has been at the forefront of cardiac lead extraction technology. Our latest devices in the Evolution RL line offer physicians the ability to control either uni-directional or bi-directional operation for mechanical extraction of problematic pacemaker and ICD leads and indwelling catheters," Cook Medical lead extraction head Louis Goode said in prepared remarks. "We’re very pleased to be able to again provide these devices to U.S. physicians."