East End Medical Gets 510(k) Clearance for Cardiac Balloon Introducer System
Miami, Fla.-based East End Medical has received the FDA’s 510(k) clearance for its SafeCross transseptal radiofrequency puncture and steerable balloon introducer system for cardiac procedures.
The system can be used for a variety of procedures, including left atrial appendage closure, transcatheter mitral valve repair and atrial fibrillation ablation, the company said.
The three-in-one system includes a steerable introducer sheath, a positioning balloon and a radiofrequency dilator. The contrast-filled positioning balloon, which is ultra-visible under echocardiography and x-ray, enables accurate positioning during surgery.