Kalios, an adjustable ring to repair the mitral valve
Kalios is the first mitral annuloplasty device that can be percutaneously adjusted to optimize valve repair at any time after implant, repeatedly, and while the heart is beating, thus avoiding the need for further surgery.
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Results among patients with implants are excellent. In our centre, we have successfully adjusted Kalios for a patient who had a functional mitral insufficiency relapse 11 months after their surgery. Thanks to the trans-catheter procedure, we avoided further cardiac surgery.
Professor Alberto Albertini, Head of the Cardiovascular Surgery Chief Service at the Maria Cecilia de Cotignola Hospital in Italy.
This product is under clinical investigation.
Configuration at implants
Includes a connection line (thin tube) that remains implanted with its distal orifice placed in subcutaneous position for easy access to the setting (like a pacemaker).
With the three-balloon catheter inserted with connectors.
Mitral regurgitation occurs when blood partially back-flows from the left ventricle to the left atrium during systole, due to improper closure of the mitral leaflets.
Kalios can be implanted as a conventional “Carpentier” ring to perform a standard annuloplasty. If recurrent mitral regurgitation occurs months or years after the initial surgery and when the implant is stabilized, it can still be adjusted to improve coaptation.
Therapy
During implantation, the connection line's distal end is routed to a subclavian position.
If residual regurgitation occurs, the spacing mandrel is retrieved from the hollow structure of the ring via the connection line.
A three-balloon catheter is inserted and inflated in three predefined zones (P1, P2, P3) to bring the valve leaflets closer, under echography guidance, to eliminate residual regurgitation.
Maximum valve orifice reduction is limited to around 15% to prevent stenosis, with full adjustment in all three zones.
The connection line is retrieved, the mandrel removed, and the three-balloon catheter reinserted for further adjustments, which can be repeated multiple times post-operatively.
Affluent Medical is currently developing investigational medical devices not yet available commercially.
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