Polypropylene KwiKnot™ Accessory to the NobleStitch™ EL, HeartStitch® MR, TA, Pilot, TCP and AP.
The KwiKnot™ is a polypropylene knot-delivery system which is an accessory to the NobleStitch™ EL and HeartStitch® line of suture based products that allows the physician to deliver a polypropylene knot to the suture site at a remote location, and includes and integrated suture cutter.
Maybe you mean: 'home-patient' or 'home-doctor-us' or 'home-doctor-eu-row' or 'NobleStitch-EL-video' or 'comingsoon'
US CLEARANCE AND EUROPEAN APPROVAL STATUS
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.
NobleStitch™ EL and accessories are CE marked in the European Union for Patent Foramen Ovale (PFO) Closure and Cardiovascular suturing.
Before use of the NobleStitch™ EL refer to the Instructions For Use.
HeartStitch® MR and TA sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The HeartStitch® MR and TA are not intended for blind vascular closure.
Covered by or for use under one or more of the following U.S. patents and their foreign counterparts: 6733509, 8197497, 8197510, 8372089, 8469975, 8709020, 8771296, 9131938, and 9642616.