Paladin Carotid PTA Balloon with Embolic Protection Filter Cleared by FDA
Contego Medical, out of Raleigh, North Carolina, won FDA clearance for its Paladin carotid PTA (Percutaneous Transluminal Angioplasty) balloon catheter. The device, used to open up narrow arteries and to post-dilation of self-expanding stents, has a built-in embolic protection filter that traps any debris that may become dislodged and forced to flow downstream of the treatment site.
The filter has pores only 40 micron in width, allowing it to grab onto pretty small pieces of plaque while letting whole blood flow through. The filter is connected directly to the balloon and the two are delivered and deployed at the same time. The filter is expanded using a hand controller and its cross sectional area can be custom set specifically to match each patient’s vessel size.
“Minor stroke continues to be the Achilles heel of carotid artery stenting, which occurs as a result of micro-embolization during the procedure,” in a statement said William Gray, M.D., System Chief of the Division of Cardiovascular Disease at Main Line Health in Wynnewood, Pennsylvania. “The Paladin System offers optimized micro-embolic protection during the most vulnerable aspects of the procedure, without additional device transitions or procedural time.”