THE NEOCHORD PROCEDURE, WORLDWIDE EXPERIENCE AND STATE OF THE ART

Giovanni Speziali, M.D.

The Neochord Operation

Beating heart procedure

provides real-time

confirmation of repair

Off pump avoids complications

due to bypass and cross-clamp

Real-time visual feedback

(TEE) permits dynamic

adjustment of chords versus

static adjustment in standard

surgery

Leaflet Capture and Verification SystemFiber Optic Confirmation

Four white lights on monitor correspond to

leaflet coverage over the four fiber optic lights

in the jaws of the device

Needle Placement

Placement of NeoChords

Retrieval and Re-Positioning of NeochordsEchocardiographic Confirmation

Confirmation of proper

placement prior to knot by

echocardiography (gently pull

down to assess leaflet motion)

Placed neochord can be

removed prior to placing knot

if the position does not appear

satisfactory

Preserves Future Treatment Options

Surgical mitral valve repair

Interventional annular treatment

Interventional leaflet repair

NeoChord Case Presentation54 Year Old Male Patient with P2 Prolapse and Severe MRCourtesy of Diana Zakarkaite, M.D.Vilnius University Hospital Santaros Klinikos

Pre-op echoes show P2 prolapse with single anterior-directed jet and severe MR

Capturing prolapsing P2 segment with device jaws

Tensioning NeoChord to pull prolapsing P2 segment down and re-establish coaptation

Post-op echoes following placement of 4 NeoChords achieving 4-5 mm of coaptation

Assessment of post-procedural MRKey concept: over-tensioning

NO! YES!

As presented by Giovanni Speziali, M.D. at PCR London Valves, September 2017

Not Only P2:

Also for Anterior leaflet

prolapse/flail

Patient Selection by Mitral Valve Morphology

Preoperative TEEMV Anatomical type definition

TYPE A

Preoperative TEEMV Anatomical type definition

TYPE B

Preoperative TEEMV Anatomical type definition

TYPE C

NeoChord Five-Year Durability Data on Initial Patients (Leipzig Heart Center)

Good Five-Year Durability of Transapical Beating Heart Off-Pump Mitral

Valve Repair With Neochordae1

“In select patients MV repair using the NeoChord system results in

very good long term results without recurrent prolapse, MR, or annular dilatation.”1

1Kiefer P, Meier S, Noack T, Borger MA, Ender J, Hoyer A, Mohr FW, Seeburger J, Good Five-Year Durability of Transapical Beating Heart

Off-Pump Mitral Valve Repair With Neochordae, The Annals of Thoracic Surgery (2018), doi: 10.1016/j.athoracsur.2018.01.092.

• Mitral annular dilatation was moderate at the time of surgery and did not

show further increase over time

Patient 1 Patient 2 Patient 3

FOLLOW-UP

NYHA pre-op II-III II-III II-III

NYHA 5Y-FU I-II I I

MR grade pre-op severe severe severe

MR grade 5Y-FU trace mild-

moderate

mild

AP Diameter (mm)

End Systolic pre-op

27 32 39

AP Diameter (mm)

End Systolic 5Y-FU

27 30 37

Kiefer P, Meier S, Noack T, Borger MA, Ender J, Hoyer A, Mohr FW, Seeburger J, Good Five-Year Durability of Transapical Beating Heart Off-

Pump Mitral Valve Repair With Neochordae, The Annals of Thoracic Surgery (2018), doi: 10.1016/j.athoracsur.2018.01.092.

NeoChord Five-Year Durability Data on Initial Patients (Leipzig Heart Center)

Seven Centers Enrolled 213 Patients, 2013-2016

Eur J Cardiothorac Surg 2018; doi:10.1093/ejcts/ezy064

Secondary Analysis of Results by Anatomical Group Was Performed

Patient Demographics and Preoperative Echocardiographic Characteristics

Procedural and 30-Day Outcomes

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In the U.S: Ongoing FDA Pivotal TrialProspective Randomized Multicenter

• Study Arm:

• 220 Patients with P2 or A2 prolapse (or flail) and “Ideal Anatomy”

• NeoChord procedure

• Control Arm:

• 220 Patients with P2 or A2 prolapse (or flail) and “Ideal Anatomy”

• Open repair on CPB (any technique, any access)

Nested High-Risk Registry (not randomized): Up to

75 Patients with prolapse or flail,even if not Ideal Anatomy,

but not suitable or too high-risk for conventional surgery

Subject has an indication for isolated surgical mitral valve repair per ACC/AHA and ESC/EACTS

guidelines.

Subject has Severe (degenerative) mitral valve regurgitation per Echo Core Lab assessment.

Subjects ≥ twenty-one (21) years of age.

Subject is a candidate for mitral valve surgery with cardiopulmonary bypass.

Subject with history of Coronary Artery Disease amenable to PCI should have completed the PCI

procedure at least three (3) months prior to index procedure.

Subject may have a history of previous Coronary Artery Bypass Graft(s)

Anatomical considerations:

Isolated segmental prolapse of the P2 or A2 segment.

Anterior leaflet covers at least 65% of the anterior-posterior annular length.

Anatomic suitability as determined by Subject Screening Committee

Subject has provided written informed consent and authorization for release of personal health

information prior to index procedure.

FDA Pivotal Trial Inclusion Criteria

Primary Effectiveness Endpoint

Freedom from moderate/ severe mitral

valve regurgitation at one (1) year and;

Freedom from mitral valve replacement or

mitral valve re-intervention at one (1) year.

Core Lab: Paul Grayburn, Baylor University, Dallas TX

NeoChord Generation 2

Note: The NeoChord Gen 2 is a future device that is not approved in any market.

• Dedicated sheath

• Ergonomic design

• Simplified procedure

• 360° jaw rotation

• Guide wire compatible

Procedure replicates current

approach:

Leaflet capture

Needle actuation

Girth hitch knot

Separate anchoring system in LV

Tensioning and release

NeoChord Transcatheter / Transseptal

Note: This is a future device that is not approved in any market.

THANK YOU