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BEATING HEART REPAIR | NeoChord Artificial Chordae Delivery System
What is degenerative mitral valve disease?
Degenerative mitral valve disease is the third most common cardiovascular disease in both Europe and the United States. If left untreated, 35% of patients die from complications associated with increased morbidity.
The NeoChord DS1000 System
The NeoChord procedure is a beating heart, echo-guided treatment option for patients with mitral valve regurgitation and is proven to resolve and restore normal mitral valve function. The NeoChord DS1000 System is intended for use when the native chordae tendinae have become elongated or ruptured. It is indicated for use in patients with moderate to severe degenerative mitral valve regurgitation.
The Instructions For Use are limited to customers outside of the United States. Included languages are as follows: English, Croation, Czech, Dutch, French, German, Greek, Italian, Latvian, Lithuanian, Norwegian, Polish, Portuguese, Spanish and Turkish
Click here for archived versions. Historical Use Only.
PROCEDURE | Echo Guided Procedure
The NeoChord procedure is performed via a thoracotomy. Using 2D and 3D echo guidance, the system is introduced into the left ventricle and navigated to the mitral annular plane. The prolapsing segment of the mitral valve leaflet is grasped in the expandable jaws of the NeoChord system. Typically, three to four artificial chordae are placed along the free edge of the mitral valve leaflet to re-suspend the prolapsed segment.
Using TEE, the level of mitral valve regurgitation is reduced by adjusting the length of the artificial chordae. Once regurgitation has been reduced to the desired level, the artificial chordae are secured to a pledget on the epicardium of the heart.
CLINICAL TRIALS
NeoChord is a privately held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation.
The NeoChord Artificial Chordae Delivery System, Model DS1000, meets the General Safety and Performance Requirements (GSPR) listed in Annex I of Medical Device Regulation (MDR) 2017/745 of the European Parliament of 5 April 2017 and is labeled with the CE marking of conformity.
NEOCHORD, DS1000, RECHORD, NEOCHORD CONSULTCONNECT, CONNECTCARD, ACCHORD, ULTRACHORD, the stylized logos, and Transforming Mitral Valve Repair are registered trademarks or service marks of NeoChord, Inc.
CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use.