Transcatheter mitral valve technologies

Transcatheter mitral
valve technologies
by development stage
Innovation booklet
Source: cvPipeline, April 2016
EuroPCR - 17–20 May 2016 - Paris
Programs in the Clinic
Company
Product
Abbott (US)
Tendyne TMVI
CardiAQ (US)
CardiAQ-Edwards
Valve-TA and TF
Medtronic
Neovasc
(Canada)
Intrepid TMVR
Tiara
Features
– Features a left ventricular apical tether
– Leaflet indifferent, allowing it to be placed in a variety of
pathologies
– Fully retrievable and repositionable
– Transapical delivery system
– Self-positioning, self-anchoring, and self-conforming
– Preserves sub-valvular apparatus
– Minimal risk of LVOT obstruction
– Transapical and transseptal delivery systems
Status
CE Mark trial
planned, US
Feasibility study
underway
Abbott acquired
Tendyne 9/15
CE Mark
trial (RELIEF)
planned, US
Feasibility study
underway
Edwards acquired
CardiAQ 8/15
– Dual stent system
– Fixation and sealing is achieved by a “cork”effect
First-in-man
produced by variable stiffness along the height of the outer study underway
stent
in Poland
– Transapical delivery
– D-shaped trileaflet mitral valve to match the natural shape
of the mitral orifice
– Spares chordal structure
– Transapical delivery system
Notes
CE Mark trial
planned, US
Feasibility study
underway
Medtronic acquired
Twelve 10/15
35 mm valve used
initially; 40mm valve
now available for
clinical use, 45 mm
valve in development
Programs in the Clinic
Company
Product
Features
Notes
Braile
Biomedica
(Brazil)
Inovare Mitral
– Self-expandable valve for use in the native mitral valve
OUS First-in-man study
planned
Caisson (US)
Caisson TMVR
– Modular approach to treating MR
- Transfemoral delivery system
Founders associated with
Myocor; LivaNova has an
investment stake
Cephea (US)
Cephea TMVR
– Designed to recreate the annular plane, mimicking the surgical approach Abbott has an investment
– “Unique” folding mechanism enables transseptal delivery
stake and an option to
– Transseptal delivery system
acquire
Direct Flow
Medical
DFM TMVR
– Double-ring valve for optimal sealing
– Valve design accommodates D-shape of the mitral annulus
– Metal-free design/profile facilitates transseptal delivery
– Transapical delivery system
HighLife System
– Respects the mitral valve anatomy
– Porprietary Loop Placement Catheter (LPC)
– Self-centering and self-positioning upon release
– Procedure fully reversible to valve deployment
– Transapical or transatrial delivery
HighLife
(France)
Preclinicals completed;
LivaNova has an investment
stake
Programs in the Clinic
Company
Product
Features
Notes
HT Consultant
(Switzerland)
Saturn TMVR
– Annular structure to “embrace” the mitral valve
– Valved central element that is expanded inside the mitral orifice to fit the
annular structure
– Transapical delivery system
Inventor is Giovanni Righini
Lutter
(Germany)
Lutter valve
– Mitral valved stent
– Ventricular fixation system
– Transapical delivery system
Inventor is Georg Lutter
MitralHeal
(Israel)
MitralHeal
– Not sensitive to native mitral valve size or shape
– 1 size fits all
– Designed to eliminate any paravalvular leak
MitrAssist
(Israel)
MitrAssist Valve
– Fits into the existing mitral valve
– Delivered through a small-diameter catheter
– Treats all forms of mitral regurgitation
– Potential for repositioning
– Transfemoral delivery system
Founded by Israeli innovator
Gil Naor
Navigate (US)
Navigate TMVR
– Features a nitinol stent and dehydrated tissue
– Annular winglets around lower portion of the valve for secure anchoring
– Delivery options include a transseptal approach
Technology licensed from
Cleveland Clinic
Programs in the Clinic
Company
Product
Features
SINOMED
(China)
AccutFit
– Reverse leaflet and conventional leaflet versions designed to eliminate
central leakage
– Includes a sealing ring design (synthetic material) to minimize PVL and a
valve holder for optimal valve positioning
– Transapical delivery system
Transcatheter
Technologies
(Germany)
Tresillo
– Pre-mounted valved stent that is folded without the need of an outer
sheath
– Allows for multiple-shot repositioning and retrieval
– Transfemoral delivery system
Valtech (Israel)
CardioValve
– 5 degress of steerability
– Ventricular and atrial anchoring mechanism
– Transseptal and transapical delivery systems
Notes
Early Stage Programs
Company
Product
Features
Emory
University (US)
MitraCath
– Based on the use of a nesting design between 2 opposing selfexpanding stents
– Separates the impact of variability in a patient’s valve/annular geometry
from the bioprosthetic valve to be implanted
INVALV
(France)
INVALV Device
– OUS patent WO2013072498
Micro
Interventional
Devices (US)
Endovalve
– Foldable valve replacement system to treat mitral regurgitation
– Features use of Perm seal device to create operative window for
procedure
– Transapical delivery system
Mitralix (Israel)
MAESTRO
– Company has announced plans to develop a percutaneous mitral valve
replacement device
Mitraltech
(Israel)
Mitraltech TMVR
– IP describes a collapsible prosthetic valve designed for full or partial
replacement of the native mitral valve
MITRICARES
(France)
MITRICARES Device
– IP describes an anchoring device for implanting a prosthetic heart valve
at a valve annulus of a patient
Nakostech
(France)
Nakostech TMVR
– IP describes an expandable mitral valve replacement system with a
reliable locking system
Notes
Inventors are Drs. Sai
Muralidhar Padala and
Vinod Thourani
Original development
company acquired by Micro
Interventional Devices
One of the founders is Israeli
innovator Yossi Gross
Early Stage Programs
Company
Product
Features
ATLAS TMV
– Designed to preserve original anatomy
– Includes an optional sealing membrane to prevent paravalvular leakage
– Transapical delivery system
Transcatheter
Technologies
Tresillo
– Pre-mounted valved stent folded witout the need of an outer sheath,
enabling precise controlled positioning, repositionable
– “Platform” technology that will be utilized for several devices (including
TAVI systems)
Transmural
Systems
Transmural TMVR
– IP describes a valve prosthesis that includes a series of connected
loops that form a structure for placement in the annulus
St. George
(Bahamas)
Notes
Transcatheter mitral
valve technologies
by development stage
Innovation booklet
Source: cvPipeline, April 2016