| Stepty®P
hemostasis device |
| Purpose |
Effective
and comfortable hemostasis following transradial
puncture. However, this device was not designed for
prolonged 6F radial artery cannulation and is therefore
not (yet) officially approved for this purpose. |
| Description |
The
Stepty®P consists of a pad of non woven cloth of piled
cotton and rayon fiber and a layer of foam polyethylene.
This 15x27 mm pad (9mm thick) is covered by a plate and
an adhesive backing layer of 40x120 mm, consisting of
elastic polyurethane. Immediately after removal of the 6F sheath
from the radial artery, the Stepty®P is applied. By
stretching of the backing, compression by the pad is
increased. Following a minimal application time of 6 hrs,
the device is removed, followed by sterile dressing of
the puncture site.
|
|
| Investigator |
F.
Kiemeneij. ADIC-OLVG Amsterdam. The Netherlands |
| Results |
Following
21 transradial procedures, hemostasis was effectively
achieved in 18 pts (86%) with a single Stepty®P. In 17
pts the device was placed within ˝ to 1 minute (81%). In
3 pts additional dressing was required because of
misplacement by the doctor (n=2) and because no
hemostasis could be obtained (n=1). In all pts,
hemostasis was effectively established during the time of
application (6.6 hr). In 1 patient the Stepty®P was
inadequately repositioned because of discomfort, for
which an additional compression bandage was required.
Patients scored discomfort during application on 1.8
(scale 1-10) and after removal on 1.1. The comfort of
Stepty®P was judged by the patient on 8,2 (scale 1-10;
10 is best). |
| Company |
- Nichiban Corporation,
Ltd
|
| Ordernumber |
--- |
| Status |
NOT YET
COMMERCIALLY AVAILABLE FOR TRANSRADIAL CORONARY
PROCEDURES |
| Comments |
The Stepty®P
is easy to apply after 6F sheath removal from the radial
artery and saves labour of medical and nursing staff.
Hemostasis is effectively established. The device is well
tolerated and is positively judged by the patient. |
