The versatile, non-pharmacologic choice for cervical ripening1,2

DILAPAN-S TODAY

for planned inductions tomorrow

Gentle enough for her to sleep through, predictable enough for you to schedule around3

HOW DILAPAN S WORKS

-

DILAPAN-S IS A NON-PHARMACOLOGIC, MECHANICAL CERVICAL DILATOR

designed for gentle, safe, and predictable cervical ripening in the induction of labor1-4

It is composed of Aquacryl®, a firm, synthetic, patented hydrogel that increases in volume by absorbing fluids.2  

 

  • Each rod swells to several times its original diameter through absorption of moisture from the cervix.

  • Approximately 80% of rod swelling occurs within the first 4-6 hours after insertion. 

  • In a single procedure typically 3 to 5 rods are inserted, with the rods inserted one at a time.4,6

0 Hours

Dilapan-S

at insertion

2 Hours

4 Hours

8 Hours

12-24 Hours

Dilapan-S

at removal

Each 4mm rod can expand up to ~15mm in diameter1,2

Make Dilapan-S your first-choice cervical ripening agent

MULTIPLE MODES OF ACTION

After insertion, Dilapan-S initiates a cascade of biophysical, mechanical, and physiological changes in the cervical tissue that continue until removal of the rods.2,5

BIOPHYSICAL

  • Dilapan-S rods are inserted into the cervical canal, where they absorb moisture from the cervix

  • Cervical tissue softens as it dehydrates

MECHANICAL

  • Dilapan-S rods expand, exerting controlled radial pressure on the cervical canal, which dilates the cervix

PHYSIOLOGICAL

  • Stretching of the cervical tissue promotes the release of local endogenous prostaglandins 

  • Local prostaglandins initiate collagen degradation and cervical softening and ripening

With Dilapan-S the cervix gradually and predictably softens and dilates,  preparing the mother for the next step in induction of labor.2,5

CONSISTENT CLINICAL EFFICACY

DILAPAN-S® ACHIEVES RELIABLE CERVICAL RIPENING SUCCESS

In 2 clinical studies, the majority of women who used Dilapan-S did not require additional cervical ripening.3,4

93

%

%

87

(N=444)

Gupta 20184

(N=208)

Saad 20193

DILAPAN-S® PREPARES WOMEN FOR SUCCESSFUL VAGINAL DELIVERY

In 3 clinical studies, Dilapan-S achieved a vaginal delivery rate ranging from 70% to 81%.3,4,6*

Percentage

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

Overall vaginal delivery rate*

(310/444)

(169/208)

81

%

(46/61)

75

%

Gupta 20184*

Saad 20193

Vik 20146

*Includes ventouse/vacuum and/or forcep assisted delivery.
 

70

%

DILAPAN-S® PREPARES WOMEN FOR SUCCESSFUL VAGINAL DELIVERY

In 4 clinical studies, Dilapan-S achieved a vaginal delivery rate ranging from 52% to 75% among vaginal birth after cesarean (VBAC) populations.4,6,8,9**

Percentage

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

VBAC delivery rate**

Gupta 20184

Vik 20146

Maier 20158

Maier 20189

**Includes women with a history of previous cesarean delivery.

52

%

65

%

75

%

55

%

STRONG SAFETY PROFILE

NO PHARMACOLOGICALLY ACTIVE SUBSTANCES
Dilapan-S® is free from agents and attributes associated with other cervical ripening methods.1,2,5

NO UTERINE TACHYSYSTOLE
In 2 large studies representing a total of 640 women (including VBAC patients) using Dilapan-S,
there were no cases of uterine tachysystole related to Dilapan-S use during cervical ripening.
2,6

LOW RATE OF ADVERSE EVENTS
Of 444 women treated with Dilapan-S during induction of labor4:

  • <1% reported cramping or pain

  • 2.7% experienced bleeding during Dilapan-S insertion or removal

  • No maternal infections (including chorioamnionitis, urinary tract infections, endometritis, and wound infections) were attributed to use of Dilapan-S by the investigating physicians

  • No serious adverse neonatal outcomes were attributed to use of Dilapan-S

SAFE FOR MULTIPLE PATIENT TYPES3,4,9

NULLIPAROUS
 


MULTIPAROUS
 


PREECLAMPSIA

TOLAC

 

DIABETES

 

 

OBESITY

​POST-DATES PREGNANCIES (>41 WEEKS)

OLIGOHYDRAMNIOS

 

 

PRE-LABOR RUPTURE

OF MEMBRANES

HIGH PATIENT COMFORT

%

OVER 

80 

of patients were

able to sleep during

 cervical ripening6

WITH DILAPAN-S®, YOUR PATIENTS ARE FREE TO3,6:

  • Ambulate without uncomfortable tubing

  • Shower, use the toilet, and perform other normal daily activities*

  • Sleep while their cervix ripens gently and gradually

*Patients should be advised to avoid bathing, douching, and sexual intercourse while Dilapan-S is in place.

%

OVER 

93 

of patients described

the comfort of insertion

 as fully acceptable6

SIGNIFICANTLY HIGHER PATIENT SATISFACTION WITH DILAPAN-S®3

In a head-to-head trial with 419 pregnant women, patients were more satisfied with
Dilapan-S compared with Foley balloon in 3 domains (P<0.05).


Patients who received Dilapan-S reported:
            •     Better sleep (P=0.01)
            •     More relaxing time (P=0.001)
            •     Ability to perform daily activities (P=0.001)

IMPORTANT INFORMATION

SAFETY INFORMATION 

INDICATIONS FOR USE: Dilapan-S is for use by healthcare professionals trained in OB-GYN and is for use whenever cervical softening and dilation is desired such as, cervical ripening during term labor induction or gynecological procedures that require cervical preparation.


IMPORTANT SAFETY INFORMATION


Contraindication: Dilapan-S is contraindicated in the presence of clinically apparent genital tract infection. 


Warnings & Precautions: Dilapan-S is intended for single use only. Do not re-use, re-sterilize, reprocess, or use if primary packaging has been opened or damaged. Discard after use. Careful placement of the device is essential to avoid traumatic injury to the cervix or uterus (see Instructions for Use—Insertion). Do not leave in place >24 hours. 


Instruct patients to: Report any excessive bleeding, pain, or temperature elevation, and to avoid bathing, douching, and intercourse. Patients should return to the physician for removal of Dilapan-S at the indicated time, and should be instructed to not attempt self-removal under any circumstances. Potential Complications/Risks: Twisting of device during removal may cause the device to break (see Instructions for Use—Removal). Complications may include: device entrapment and/or fragmentation, expulsion, or retraction; patient discomfort or bleeding; spontaneous rupture of membranes; spontaneous onset of labor; cervical laceration.


Storage & Handling: Store between +15 °C and +30°C and keep away from direct sunlight and high humidity.

Adverse events: You may report a product complaint or adverse event related to the use of Dilapan-S by calling 1 (888) 257-9676

(United States Only). 

Please see accompanying Instructions for Use.

REFERENCES

1. DILAPAN-S® Instructions for Use. DSPIenus-Rev018/2020-04.

2. Dilapan-S® Issuance of Substantial Equivalence Determination. US Food and Drug Administration. 2015. https://www. accessdata.fda.gov/cdrh_docs/pdf13/K133898.pdf. Accessed February 24, 2020.

3. Saad AF, Villarreal J, Eid J, et al. A randomized controlled trial of Dilapan-S® vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019;220(3):275.e1-275.e9.

4. Gupta J, Chodankar R, Baev O, et al. Synthetic osmotic dilators in the induction of labour. An international multicenter observational study. Eur J Obstet Gynecol Reprod Biol. 2018;229:70-75.  

5. Drunecký T, Reidingerová M, Plisová M, et al. Experimental comparison of properties of natural and synthetic osmotic dilators. Arch Gynecol Obstet. 2015;292(2):349-354.

6. Vlk R, Hruban L, Janků P, et al. Efficacy and safety of the osmotic dilator Dilapan-S® for cervical ripening in women with/without Caesarean section. Poster presented at the 13th World Congress in Fetal Medicine, The Fetal Medicine Foundation. June 29–July 3, 2014. Nice, France.

7. Data on File. Medicem, Inc. 2020.

8. Maier JT, Schalinski E, Gauger U, Hellmeyer L. Cervical ripening with an osmotic dilator (Dilapan-S) in term pregnancies – An observational study. J Gynecol Neonatal Biol. 2015;1(3):1-6.

9. Maier JT, Metz M, Watermann N, et al. Induction of labor in patients with an unfavorable cervix after a cesarean using an osmotic dilator versus vaginal prostaglandin. J Perinat Med. 2018;46(3):299-307.

10. Hruban L, Janku O, Simetka I, et al. Effectiveness and safety of the osmotic dilator Dilapan-S® for cervical ripening in females with/ without C. section in medical history. Poster presented at XXIV European Congress of Perinatal Medicine. June 4–7, 2014. Florence, Italy.

11. Záhumenský J, Hruban L, Janků, et al. The impact of the number of pieces of osmotic dilator Dilapan-S® used for cervical ripening on the course and outcome of labor. Poster presented at the 13th World Congress in Fetal Medicine, The Fetal Medicine Foundation. June 29–July 3, 2014. Nice, France.

Watch the Insertion and Removal Video

Toll-Free Phone: (800) 850-1657

Local Phone: (540) 375-9380

Fax: (800) 361-6984

1640 Roanoke Blvd

Salem, VA 24153

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