Description:
The MSM-stent is made of surgical stainless steel. A high-precision
laser system carves uniform structures out of the raw material.
Edges, ends and struts are rounded using a special finishing procedure
to protect the vascular wall and balloon from damage.
The additional product name "BMS" (= Bio Metal Surface)
designates the implantation of biometallic atoms (tantalum) into
the surface under conditions of high-level vacuum. This surface
treatment effects the best possible biological metallic surface.
No ions are released into the blood and corrosive currents are
lower than with conventional 316 L-stents. The product MSM-CIS
(Coronar Implant System) consists of a PTCA catheter with a premounted
MSM-Stent. All stents without additional designation consist of
surgical steel 316L material, stents with additional designation
HV are high vacuum refined, stents with additional designation
BMS (Bio Metal Surface) are tantalum refined.
History:
- October 1997 first clinical experience
- March 1998 CE-mark for MSM-Stent
- August 1998 CE for MSM-CIS (Coronar Implant System)
Figure 2: The crown of the MSM-BMS stent
Tips and tricks for delivery:
The MSM-BMS Stent is premounted on a rapid exchange system,
no stent-specific tips and tricks are required. The low balloon
profile with its conical, atraumatic and flexible tip makes it
easy to position the fairly visible stent which is positioned
centered between two X-ray markers. The MSM-BMS stent is compatible
with all commercially available 6 F guiding catheters.
Indications for use:
The indications for the MSM-BMS stent follow the general rules
for stent implantation according to vessel size and stent lenght.
Range of products:
- MSM-Stent in lenghts of 9, 16, 26 mm; expandable diameters
2.5-5.0 mm.
- MSM-Stent SV (small vessel) in lenghts 6, 9, 16 mm; expandable
diameters 2.0-2.5 mm.
- MSM-CIS (coronar implant system) with premounted MSM-Stent 9,
16, 26 on balloons of 2.5, 3.0, 3.5, 4.0 and 5.0 mm in diameter.
- MSM-CIS SV with premounted MSM-Stent SV 9 and 16 mm in length
on balloons of 2.0, 2.5, 3.0 and 3.5 mm in diameter.
Figure 3: Severe lesion of the circumflex artery before intervention
Why I like my stent:
- Surface reduces thrombin formation, platelet adhesion and
activation
- High long-term bio- and hemocompatibility due to a bio metal
surface
- Smooth surface with no internal flaring of the greater a curvature
- No release of chromium and nickel ions
- High radial strength and very low recoil
- Moderate degree of radio-opacity
- Excellent conformity to the vessel shape after deployment
- No significant shortening
- Easy tracking through tortous vessels
- Multiple lengths and diameters
- Easy and secure crimping on balloon
- Customized lengths in steps of 2.5 mm on request
On-going and planned trials:
The stent is currently under clinical investigation in a non
randomized observational study. A randomized clinical multicenter
study to compare the MSM-stent versus the MSM-BMS-stent is planned.
MSM-stent BMS delivery system:
| Mechanism of deployment: | Balloon expandable |
| Protective sheath: | No |
| Monorail system | Yes |
| Minimal internal diameter of guiding catheter: | 0.064 inch (1.6 mm), 6 F |
| Longitudinal flexibility: | High |
| Position of radio-opaque markers: | Proximal and distal to stent |
| Rated burst pressure of balloon: | 15 atm |
| Balloon material: | PAMAX™ |
| Balloon compliance: | Nominal at 6 atm |
MSM-BMS stent technical specifications:
| Material composition: | 316 LVM stainless steel, biometal surface (BMS) with tantalum |
| Degree of radio-opacitism (grade): | Moderate |
| Ferromagnetism: | Non-ferromagnetic (MRI safe) |
| Metallic surface area (metal: artery expanded): | 21% at 2.5 mm diameter 18% at 3.0 mm diameter 11% at 5.0 mm diameter |
| Stent design: | Slotted tube, 10 support and extension elements, 5 flexible length contraction compensation elements (LCCE) at the stent´s circumference |
| Strut dimensions: | ca. 0.0032 inch (0.08 mm) thick |
| Profile on the balloons: | ca. 0.9-1-1 mm |
| Longitudinal flexibility: | High |
| Percentage shortening on expansion: | < 3 % |
| Expansion range: | 2.5 - 5.0 mm (2.0 - 3.5) |
| Degree of recoil (shape memory): | < 3.3 % |
| Currently available diameters: | 2.0, 2.5, 3.0, 3.5, 4.0 and 5.0 mm |
| Currently available lengths | |
mounted: |
16 and 26 mm |
unmounted: |
6, 9, 16 and 26 mm |
| Recrossability of implanted stent: | Good |
| Other non-coronary types available: | None |