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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.

IFU
   The Instructions For Use are limited to customers outside of the United States

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.

Using intra-operative TEE, leaflet capture is confirmed in real time and verified using the fiber optic display.

Restored Valve Function

Pre-Operative
Post-Operative

CLINICAL TRIALS

Randomized Trial of the NeoChord DS1000 System versus Open Surgical Repair

The objective of this study is to assess the safety and effectiveness of the NeoChord DS1000 System in subjects with degenerative mitral valve disease. The study is designed as a randomized controlled trial comparing use of the study device versus Open Surgical Repair.

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A post‐market effectiveness registry of the NeoChord Artificial Chordae Delivery System

The objective of this study is to further describe the performance of the NeoChord DS1000 System in a post-market setting. The study is a prospective, multi-center, non-randomized design including isolated NeoChord procedures and combination valve repair procedures using the NeoChord DS1000 System and other commercially available beating heart mitral valve repair technologies.

PUBLICATIONS

December 8th, 2020
August 1st, 2020
May 19th, 2020
March 9th, 2020
August 28th, 2019

NeoChord ConsultConnect and ConnectCARD is a medical consultation and service related to delivery of artificial chordae tendineae for treatment of mitral insufficiency.

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NeoChord is a privately held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation.

NeoChord ConsultConnect and ConnectCARD is a medical consultation and service related to delivery of artificial chordae tendineae for treatment of mitral insufficiency. The NeoChord Artificial Chordae Delivery System, Model DS1000, meets the essential requirements referred to in Article 3 of the MDD 93/42/EEC 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.

CONTACT

(952) 698-7800

info@neochord.com

NeoChord, Inc
5402 Parkdale Drive,
Suite 160 St. Louis Park,
MN 55416