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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 SoftFlexor FirmFlex style for easy one-step sampling.  The SoftFlexis ideal for standard or routine patient sampling applications where a more flexible cannula is desired by the clinician.  The FirmFlexis 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 SoftFlexand 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  Once properly positioned, the plunger is withdrawn and the design generates sufficient vacuum for maximum endometrial sample yield to be captured within the cannula sleeve without the need for external suction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

 

 

SURG-ENDCAN-HI

Endometrial Biopsy Cannula Hi-Light

 

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30-3010 and 30-3012

30-3015