MILTONIA
Bi-Leaflet Mechanical Heart Valve
The MILTONIA Mechanical Heart valve is a Bi-Leaflet Heart Valve made up of highly durable Pyrolytic Carbon on a Graphite substrate. The Pyrolytic Carbon is Silicon (Si) alloyed and contains around 3 to 8 % of Silicon(Si) and around 12% Tungsten(W) for radiopacity.
The Polished Silicon alloyed varieties of Pyrolytic Carbon exhibit an excellent degree of thromboresistance while improving resistance to wear, offering excellent and durable results.
An open pivot design provides a Passive Washing mechanism of pivot which minimizes thrombolytic events. The Orifice ring consists entirely of Pyrolytic Carbon. In the full open position, the plane of each leaflet forms a nominal angle of 85° relative to the plane of the orifice ring.
The valve Sewing cuff is made up of Double Velour Polyester fabric and is mounted on the orifice using a Titanium(Ti) Stiffening ring and secured with two Titanium(Ti) Lock rings and a Lock wire. This method of Sewing cuff attachment to the orifice allows for rotation of the carbon orifice in situ during implantation. Three markers are located in the aortic Sewing ring and four markers are located in the mitral sewing ring to assist in the uniform placement of sutures around the valve annulus.
Benefits
Bileaflet design with 85 degree opening - Pyrolytic carbon coating over graphite substrate, Tungsten(W) impregnated leaflets for radio-opacity
SEWING RING (multiple variants available) - Made of double velour polyester that encourages endothelialisation, gives ease in suturing and avoids suture looping and suture knots
OPEN PIVOT DESIGN - Convex hinge the mechanism which protrudes slightly from the inside of the valve orifice on which the leaflets rest
CARBON RIM with rotation mechanism - Carbon rim made of pyrolytic carbon.
The sewing ring is mounted with the help of a Titanium(Ti) stiffening ring and secured with Titanium(Ti) lock ring and lock wire. This allows for the creation of a track for rotation of the carbon rim
Advantages
Durability
- The leaflets of the MILTONIA valves are made of Pyrolytic Carbon over Graphite substrate and Tungsten(W) impregnation. The presence of Tungsten(W) provides better radiopacity allowing a non invasive diagnostic observation of the leaflet motion through fluoroscopy or similar methodologies.
- The Pyrolytic Carbon consists of 3-8% Silicon(Si) and this adds to the strength of the Pyrolytic Carbon.
- The Orifice ring consists entirely of Pyrolytic Carbon with a Titanium(Ti) Stiffening ring. The Titanium(Ti) Stiffening ring increases the strength multiple times and thus minimizes the risk of deformation of the Carbon rim.
- The method of Sewing cuff attachment to the Orifice allows for rotation of the sewing ring in-situ, during surgical placement.
Hemodynamics
- The opening angle of leaflets are 85 degree which ensures large EOA (effective orifice area) with lower pressure gradient and provides better haemodynamics.
Thromboresistance
- An open pivot design ensures space between the leaflet and the hinge area leading to proper passive washing of the pivot area.
- This prevents blood stasis and lowers the chances of thrombus formation.
- A Smooth Blood contact surface and a laminar flow ensures less turbulence and hence chances of eliciting platelet activation is low.
Implantability
- The Miltonia bileaflet valve is a low profile heart valve with minimal vertical leaflet exposure as well as an adequate posterior wall clearance.
- This minimizes the chances of coronary ostia blockage in the aortic position and the chances of subvalvular impingement in the mitral position are also reduced.
- There are two cuff variants in Aortic (compact) and Mitral (flared) for easier implantation. Valve comes with an inbuilt rotation mechanism.
MILTONIA Open Heart Surgery for Heart Valve Replacement
MILTONIATM Mechanical Bi-Leaflet Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves
Product Specifications
Specification |
Sewing Ring Diameter (mm) | Tissue Annulus Diameter (mm) | Orifice Outer Diameter (mm) | Orifice Inner Diameter (mm) | Geometric Orifice Area (cm²) | Overall Height (mm) | Opening Angle (⁰) | |
---|---|---|---|---|---|---|---|---|
Catalog No. | ||||||||
Standard | ||||||||
MLT19A | 19.8±2 | 19±2 | 16.2±1 | 14.8±1 | 1.55±1 | 8.7±1 | 85±5 | |
MLT21A | 21.8±2 | 21±2 | 18.2±1 | 16.8±1 | 2.02±1 | 9.7±1 | 85±5 | |
MLT23A | 23.8±2 | 23±2 | 20.2±1 | 18.8±1 | 2.56±2 | 10.9±1 | 85±5 | |
MLT25A | 25.8±2 | 25±2 | 22.2±1 | 20.8±1 | 3.17±2 | 12.1±1 | 85±5 | |
Aortic Valve | MLT27A | 27.8±2 | 27±2 | 24.2±1 | 22.8±1 | 3.84±2 | 13.1±1 | 85±5 |
Advanced Performance (AP) | ||||||||
MLT16AP | 19.8±2 | 16.2±2 | 16.2±1 | 14.8±1 | 1.55±1 | 8.7±1 | 85±5 | |
MLT18AP | 21.8±2 | 18.2±2 | 18.2±1 | 16.8±1 | 2.02±1 | 9.7±1 | 85±5 | |
MLT20AP | 23.8±2 | 20.2±2 | 20.2±1 | 18.8±1 | 2.56±1 | 10.9±1 | 85±5 | |
MLT23M | 31±2 | 23.8±2 | 20.2±1 | 18.8±1 | 2.56±2 | 11.5±2 | 85±5 | |
MLT25M | 33±2 | 25.8±2 | 22.2±1 | 20.8±1 | 3.17±2 | 12.5±2 | 85±5 | |
MLT27M | 35±2 | 27.8±2 | 24.2±1 | 22.8±1 | 3.84±2 | 13.5±2 | 85±5 | |
Mitral Valve | MLT29M | 37±2 | 29.8±2 | 26.2±1 | 24.8±1 | 4.59±2 | 14.4±2 | 85±5 |
MLT31M | 39±2 | 30.8±2 | 26.2±1 | 26.8±1 | 5.37±2 | 14.4±3 | 85±5 | |
MLT33M | 41±2 | 33.8±2 | 28.2±1 | 28.8±1 | 5.37±2 | 14.4±3 | 85±5 |
Size Chart
Product Code | Material Description | Pack Size | |
Standard | |||
MLT19A | MILTONIA, Bi Leaflet Mechanical Valve, 19mm Aortic | Single | |
MLT21A | MILTONIA, Bi Leaflet Mechanical Valve, 21mm Aortic | Single | |
MLT23A | MILTONIA, Bi Leaflet Mechanical Valve, 23mm Aortic | Single | |
MLT25A | MILTONIA, Bi Leaflet Mechanical Valve, 25mm Aortic | Single | |
Aortic Valve | MLT27A | MILTONIA, Bi Leaflet Mechanical Valve, 27mm Aortic | Single |
Advanced Performance (AP) | |||
MLT16AP | MILTONIA, Bi Leaflet Mechanical Valve, 16mm Aortic | Single | |
MLT18AP | MILTONIA, Bi Leaflet Mechanical Valve, 18mm Aortic | Single | |
MLT20AP | MILTONIA, Bi Leaflet Mechanical Valve, 20mm Aortic | Single | |
MLT23M | MILTONIA, Bi Leaflet Mechanical Valve, 23mm Mitral | Single | |
MLT25M | MILTONIA, Bi Leaflet Mechanical Valve, 25mm Mitral | Single | |
MLT27M | MILTONIA, Bi Leaflet Mechanical Valve, 27mm Mitral | Single | |
Mitral Valve | MLT29M | MILTONIA, Bi Leaflet Mechanical Valve, 29mm Mitral | Single |
MLT31M | MILTONIA, Bi Leaflet Mechanical Valve, 31mm Mitral | Single | |
MLT33M | MILTONIA, Bi Leaflet Mechanical Valve, 33mm Mitral | Single |
Clinical Data
Product IFU
Note: IFU will be displayed after MDR Certification