Mechanical 'ROSCARDIKS' heart valves
In order to offer a wide range of devices for cardiosurgeons, a new design of bileaflet heart valve 'MIKS-ROSCARDIKS' has been developed as well as the conduits and annuloplastic rings.
The mechanical bileaflet heart valves 'MIKS-ROSCARDIKS' are produced according to Russian State Standards ÃÎÑÒ 26997 and Technical Specifications ÒÓ 9444–002–18103798–2002.
The design of the new 'MIKS-ROSCARDIKS' valves is in mass production and broadly implanting in clinics now. It was patented in the USA — US 6,569,197 B2 May 27, 2003.
The main advantages of 'MIKS-ROSCARDIKS' valves in comparison with well known foreign brands are the following:
- Haemodynamic effectiveness;
- Total wash of the valve elements with blood.
RK — MIKS-ROSCARDIX, CM — Carbomedics, SJM — St. Jude Medical
The high quality and reliability of heart valves manufacture and technology based on the Certificate of Safety and the License issued to ’Roskardioinvest’ after a wide range of testing.
Since the 'MIKS-ROSCARDIKS' valves are in use there were no failures because of its mechanical dysfunction neither during implantation nor after it.
'Roscardics' heart valve specifications
The technical characteristics of 'MIKS-ROSCARDIKS' valve are as good as characteristics of foreign one, and by some parameters are even better. Reasonable price of such valves is also a prime advantage.
'MIKS-ROSCARDIKS' heart valve characteristics:
The valve design has been optimized to provide patients with all advantages in haemodynamics with minimal weight.
Height of the open valve — 8.6 — 13.6 mm
Mass — not more than 5.5 g
Opening angle — 86°
Orifice area — 1.76 — 4.79 cm2
The valve design, producing technology and materials ensure the mechanical reliability and durability of it.
The valve housing ring is made of one-piece of special-purpose titanium either BT1-O or BT6 with surface deposited carbon layer.
The leaflets are made of high-strength carbon material UGLESITAL which was developed and made in Russia.
The cuff material is medical knitted fabric, polyester fabric and carbonized fabric VITLAN. The choice of material depends on the need. The cuff has ability to rotate around the housing ring of the valve.
The durability of the 'MIKS-ROSCARDIKS' valves is guaranteed for at least 20 years after the implantation day.
Each valve has been tested for its productivity and regurgitation volume. The test results are put down into Valve Certificate.
The average pressure drop on the valve in aortic position is about
The valve leaflets move easily inside the valve ring without any risk of blocking. That was confirmed by the tests of produced valves. The housing ring design provides effective wash-out of the hinge mechanism in the zones of leaflets fixing.
The increased thromboresistance of valves 'MIKS-ROSCARDIKS' is provided by many factors. Both the surface deposited carbon layer and carbonized fabric for knitted cuff are among them.