Less Invasive Vascular and Cardiovascular Sutures
NobleStitch™ EL and accessories are FDA cleared for use in vascular and cardiovascular procedures in the United States.
The device is not indicated for blind vascular closure. The NobleStitch™ EL is not indicated for use in blind settings where visualization techniques (optical, ultrasound, fluoroscopy,endoscopy etc.) are generally contraindicated or not feasible. The NobleStitch™ EL is not indicated for use in sites where the tissue will not accommodate an adequate “bite” for suturing.
Before use of the NobleStitch™ EL refer to the Instructions For Use for cautions, warnings and contraindications.
Warning: The safety and effectiveness of this device in percutaneous cardiac procedures such as closure of septal defects (patent foramen ovale, atrial septal defects and ventricular septal defects), closure of the left atrial appendage, and heart valve repair has not been established.
Covered by or for use under one or more of the following U.S. patents and thier foreign counterparts: 6733509, 7803167, 8197497, 8197510, 8246636, 8372089, 8469975, 8496676, 8709020, 9131938, and 9642616.