Features & Benefits
Clinical/Product Information
Literature
Accessories
Features & Benefits
Miltex has a
newly expanded line of disposable endometrial sampling and biopsy
products to meet the Clinician’s needs for evaluating both pre- and
post-menopausal female patients with conditions of abnormal uterine
bleeding, infertility, potential endometrial cancer, hormonally
induced changes to the uterine lining, or to follow-up on the
presence of endometrial cells on Pap smears. These exciting new
products provide the Clinician with a safe, efficient, and
cost-effective means for collecting and evaluating samples of the
uterine endometrial lining in an outpatient setting with minimal
discomfort to the patient.
Historically,
endometrial biopsy and sampling was commonly performed using
stainless steel instrumentation such as the Novak or Randall
endometrial suction biopsy curettes. However, researchers have
found that the use of softer and more flexible plastic sampling
devices minimizes cramping and pain to the patient and yield
equivalently sufficient tissue samples for histology. Miltex offers
the following portfolio of (3) disposable endometrial sampling
devices to accommodate the standard and more routine procedures, to
the more difficult scenarios of collecting atrophied endometrium
samples or dealing with post-menopausal women where stenosis of the
cervix is a concern.
The Miltex
Endometrial Biopsy Cannula are offered in either a SoftFlex™
or
FirmFlex™
style for
easy one-step sampling. The SoftFlex™
is
ideal for standard or routine patient sampling applications where a
more flexible cannula is desired by the clinician. The
FirmFlex™
is a
slightly more rigid cannula ideal for more controlled insertion and
sampling in patient cases where atrophic endometrium or
post-menopausal patients with stenosis of the cervix is a concern.
Both
the SoftFlex™
and
FirmFlex™
patterns
are sterilized via ETO, packaged individually for single-use
applications, and provided in convenient quantities of 25 per box.
The cannula are made of a clear, latex-free and flexible
polypropylene outer sleeve with inner plunger. The cannula sleeve,
with plunger in closed position, is inserted through the cervix and
into the uterine cavity. Once properly positioned, the plunger is
withdrawn and the design generates sufficient vacuum for maximum
endometrial sample yield to be captured within the cannula sleeve
without the need for external suction devices. Detailed “directions
for use” are packaged with cannula and should be reviewed thoroughly
and carefully prior to each use or demonstration.
The Miltex
Endometrial Sampling Set is the third product solution to assist
Clinicians with the collection of clearly differentiated endometrial
tissue. The Endometrial Sampling Set is a disposable plastic
curette and syringe system which is very similar in function and
appearance to the stainless steel Randall endometrial suction biopsy
curette pattern. However, as mentioned previously, the more
flexible plastic design reduces physical discomfort to the patient.
Each Miltex
Endometrial Sampling Set includes a Disposable Curette and a 10
ml Twist-and-Lock Syringe. The curette is made of clear, latex-free
polypropylene and has a Semi-Rigid design with a slightly curved and
tapered Randall-type cutting edge tip which optimizes access to the
uterine contours and efficient sample collection. The semi-rigid
design of the curette allows for controlled insertion in female
patients with stenosis of the cervix, and the syringe system creates
21” Hg of negative pressure for optimized suction and sample capture
in situations where the endometrium is atrophic and more difficult
to capture sufficient sample yield.
Each set
is sterilized
via ETO, packaged individually for single-use applications, and
provided in convenient quantities of 10 per box. The curette is
attached to the syringe with the plunger in a closed position and
then inserted through the cervix and into the uterine cavity. Once
properly positioned, the syringe plunger should be withdrawn in a
smooth and steady motion until the piston reaches the safety end
stop of the syringe. Turn the plunger ¼ turn clockwise to lock it
into position so that sufficient vacuum for maximum endometrial
sample yield is captured in the curette sleeve. Detailed
“directions for use” are packaged with curette and syringe sampling
set and should be reviewed thoroughly and carefully prior to each
use or demonstration.
When selling the
disposable endometrial cannula and curette/syringe sets, always keep
in mind that other instrumentation is used during the procedure such
as: vaginal specula (Pederson and Graves), tenaculum
(Schroeder-Braun), uterine sounds (Sims or Simpson), and Os dilators
for gently coaxing open stenotic cervix conditions. Always try and
sell the complete disposable and stainless steel instrument
package.
|
Features |
Benefits |
|
·
3 mm O.D |
·
Appropriate size for ease of insertion without dilation in
most cases. |
|
·
3 cm –
10 cm graduated markings & tapered tip |
·
Aids
proper insertion and placement of the cannula during
specimen collection and reduces risk of uterine perforation. |
|
·
Latex-Free |
·
Eliminates potential for clinician or patient allergic
reaction to latex. |
|
·
Sterile,
disposable, and packaged 25 per box |
·
Convenient, ready to use and cost effective. Eliminates
instrument processing costs. |
|
SoftFlex™
& FirmFlex™ (PN’s 30-3010 and 30-3012) |
|
·
9-1/4”
(23.5 cm) length |
·
Allows
for insertion depth to accommodate a range of patients |
|
·
Soft &
Flexible plastic sampling device |
·
Alternative to traditional stainless steel patterns.
Minimizes cramping and pain to the patient and yields
equivalently sufficient tissue samples for histology. |
|
·
Soft &
Firm flexibility choices |
·
Optimizes formation to the natural uterine contour and
structure for obtaining specimens from the endometrial
cavity. |
|
·
SoftFlex™
Style available |
·
Ideal
for standard/routine sampling or when a more flexible
cannula is desired. |
|
·
FirmFlex™
Style available |
·
Ideal
for sampling post menopausal patients where stenosis of the
cervix exists, atrophic endometrium is a concern or a more
rigid cannula is needed for controlled insertion. |
|
·
Cannula
and inner sleeve design |
·
Offers
one-step sampling and generates sufficient vacuum for
maximum sample yield without the need for external suction. |
|
Endometrial Sampling Set (PN 30-3015) |
|
·
8-1/8”
(20.64 cm) length |
·
Allows
for insertion depth to accommodate a range of patients |
|
·
Slight
curve on Curette |
·
Optimizes access to the natural uterine contour and
structure for obtaining specimens from the endometrial
cavity. |
|
·
Semi-Rigid Curette with Tapered Tip |
·
Ideal
for controlled insertion in patients where stenosis or
atropic endometrium is a concern. |
|
·
Randall-Type sharp cutting edge |
·
Efficient sample collection. |
|
·
Packaged
as a set |
·
Convenient and ready to use. Comes equipped with a Curette
and Twist-and-Lock Syringe. |
|
·
10 ml
standard Twist-and-Lock Syringe with plunger stop and twist
lock. |
·
Creates
21” Hg continuous negative pressure for optimized suction
and sample capture and prevents the plunger from pulling out
of the syringe sheath. Twist lock feature prevents
accidental pressurization into the uterus. |
|
·
Luer
Lock fitting with winged flanges |
·
Better
grip and ease of attachment of curette to the syringe |
Clinical/Product Information
|
Part Number |
Description |
|
30-3010 |
SoftFlex™ Endometrial Biopsy Cannula, Sterile, Single-Use,
Box of 25 |
|
30-3012 |
FirmFlex™ Endometrial Biopsy Cannula, Sterile, Single-Use,
Box of 25 |
|
30-3015 |
Endometrial Sampling Set (includes Disposable Curette w/a
Twist-and-Lock Syringe), Sterile, Single-Use, Box of 10 |
Literature
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