KEPHALIOS
Optimised structural-heart technologies

Kephalios has created the first mitral repair device* that can be adjusted percutaneously at any time after the implant.
It restores leaflets coaptation so to treat both residual and recurrent Mitral Regurgitation without re-operating the patient.

* This device is not available in any market (it is not CE marked nor FDA approved)

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Why

Mitral Regurgitation ?

Mitral Regurgitation affects about 1% of the whole population, but
8-9% of the over-65’s

Out of 4,000,000 patients (in North America, the widest Europe and the Far East) suffering from severe Mitral Regurgitation who could benefit from cardiac surgery only
150,000 (3.7 %) undergo a mitral intervention every year

Mitral regurgitation patients suffer from serious deterioration of their Quality of Life and have a poor prognosis, including heart failure and early death. Mitral regurgitation can be surgically repaired by ring annuloplasty, but results are often poor and not durable:
up to 30% of patients
leave the Operating Room with some residual mitral regurgitation and up to 20% recidivate in two years. Besides mitral valve repair surgery carries high mortality and morbidity risks.

MITRAL VALVE REGURGITATION

A life-threatening condition

Mitral Regurgitation, which is also known as mitral insufficiency, is a common heart valve disorder, but also a life-threatening condition.
The mitral valve regulates the flow of blood between the left atrium and the left ventricle of the heart.
When the valve’s two leaflets fail to close completely, the blood regurgitates back into the left atrium (hence the Mitral Regurgitation condition’s name), causing the Mitral Regurgitation.
As a result, the blood flow to the body tissues and organs decreases. To compensate, the heart pumps harder, an action that may eventually lead to heart failure.

Vision

Thinking the personalised medicine of the future

Newer medical therapies tend to be more and more personalised. Kephalios participates to this movement with its mitral repair technology, that can be easily regulated both at implant and long after. This technology allows to optimise the surgical repair results, with respect to either the patient individual needs or the evolution of the disease.

We believe in new organizational models in hospitals, where interventions are done in hybrid rooms and a multidisciplinary Heart-Team identifies the best “patient journey”, well beyond the single treatment. Kephalios’ technology favours this collaborative approach, as it is conceived for a conventional surgical implant but also for a percutaneous adjustment over time.

Kephalios’ technology promotes continuity of patient care with a device that has the ability of providing both an immediate and long-term treatment.

The Quality-of-Life of patients is the focal point of our vision. The Kephalios mitral repair technology may improve both short and long-term patient outcome and, most of all, prevent the need for a second operation, a situation often met by patients with a very low compliance.

Our innovation is meant to be simple, easy to use, safe, smart and effective. It does not upset the practice of surgeons, it adds a precious tool to the toolbox of surgeons and cardiologists alike, can saves lifes and significantly improve their quality.

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Technology
and science

The technology of Kephalios consists of a mitral annuloplasty ring, that can be adjusted repeatedly and progressively after implantation for treating both residual and recurrent Mitral Regurgitation.

The Kephalios device configuration before adjustment of the P1, P2 and P3 areas. Textile cover, posterior eyelets and anterior green-line for suturing along the inner edge of the ring.

The Kephalios device configuration after adjustment with full deployment of the P1, P2 and P3 areas, with local reduction of the antero-posteriors distances of the mitral annulus.

The Kephalios device* is to be implanted by open surgery with a technique very similar to that of a classical « Carpentier » ring. However, unlike a conventional ring it remains always accessible, after implantation (in peri-op or post-op), by means of a balloon-catheter actuator, that allows to perform an adjustment of the ring shape so to reduce the antero-posterior distance of the annulus in either P1 and / or P2 and / or P3.

The local reduction of the annulus antero-posterior distance entails an increase of the leaflets coaptation length that is also localised only where needed.

With a proper adjustment, then, the coaptation can be improved in an optimal way at the minimum expense of the total valve orifice area.

 

*This device is not available in any market (it is not CE marked nor FDA approved)


Team

Expertise, passion, reputation

MANAGEMENT AND ADVISORY TEAM

Operational team

About

Kephalios is a medical device company, founded in 2011 for developing and taking to the market an innovative mitral repair technology.


Kephalios is incorporated in the form of a SAS (Société par Actions Simplifiée) under the French law.

Kephalios operating facility is located in Aix-en-Provence, in the South of France, while its headquarter in located in Paris.


Contact

contact@kephalios.eu

320 av. Archimède – Les Pléiades III – Bât. B
13100 Aix-en-Provence
France