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OUR PRODUCTS

KwiKnot

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.

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CLEARANCE STATUS

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 U.S. and international patents including U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8197510, 8246636, 8348962, 8372089, 8469975, 8496676, 8709020, and 9131938.