Next day cervical ripening
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Dilapan-S
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What is Dilapan-S?

Dilapan-S is an FDA-cleared, non-pharmacologic, mechanical cervical dilator designed for predictable, safe, and effective cervical ripening during induction of labor.1-4

Dilapan-S is composed of Aquacryl®, a firm, synthetic, patented hydrogel that expands to several times its original diameter through the absorption of moisture from the cervix.2

Use indicators to see Dilapan-S absorption.

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Dilapan-S at insertion

Why Dilapan-S?

Clinical studies demonstrate Dilapan-S to be:

An effective, predictable ripening agent3,4

  • Successful first-round cervical ripening in up to 93% of patients
  • Vaginal delivery rates as high 81%
  • Average Bishop Score increases of 3.6 points

A safe, versatile first-choice ripening agent1,3-6

  • No pharmacologically active substances
  • No uterine tachysystole
  • No additional fetal monitoring required
  • No reported serious adverse events. Of 444 women treated with Dilapan-S during induction of labor:
    • <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

High in Patient Comfort3,7,8

  • Up to 80% of women were able to sleep with Dilapan-S in place
  • Insertion comfort reported as "fully acceptable" in 93% of patients
  • Freedom to resume activities of daily living

Safe and Effective Across Patient Types3,4,6

NULLIPAROUS MULTIPAROUS OBESITY DIABETES TOLAC PREECLAMPSIA POST-DATES (>41 WEEKS) OLIGOHYDRAMNIOS

How does Dilapan-S work?

After insertion, Dilapan-S initiates a cascade of biophysical, mechanical and physiological changes in the cervical tissue that continue until rod removal.2,9

Biophysical

Dehydration of cervical tissue
  • Dilapan-S rods are inserted into the cervical canal, where they absorb moisture from the cervix
  • Cervical tissue softens as it dehydrates

Mechanical

Radial pressure caused by rod expansion
  • The Dilapan-S rods expand, exerting controlled radial pressure on the cervical canal, which dilates the cervix

Physiological

Prostaglandin release and collagen reorganization
  • Stretching of the cervical tissue promotes the release of local endogenous prostaglandins
  • Local prostaglandins initiate collagen degradation and cervical softening and ripening

Using Dilapan-S

Watch the Insertion and Removal Video

Dilapan-S rods are smooth and slightly rigid for ease of insertion.
Typically, 3-5 Dilapan-S rods are used. Dilapan-S should not be left in place more than 24 hours.1,4,5

DOWNLOAD COMPLETE
INSTRUCTIONS FOR USE

Ordering information

Please contact a distributor to set up an account

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Product Info

3 mm x 55 mm NDC: 23170310010
UOM: 10 each / box
4 mm x 55 mm NDC: 23170312410
UOM: 25 each / box
4 mm x 65 mm NDC: 23170314810
UOM: 25 each / box

Ordering

Online Portal Registration:
https://medicem.pharmarxorder.com

Phone: 844-985-1368
Fax: 614-652-9760
Email: GMB-SPS-Medicem@cardinalhealth.com

HPSRX Logo

Product Info

3 mm x 55 mm NDC: 23170310010
UOM: 10 each / box
4 mm x 55 mm NDC: 23170312410
UOM: 25 each / box
4 mm x 65 mm NDC: 23170314810
UOM: 25 each / box

Ordering

Online:
https://www.hpsrx.com

Phone: 800-850-1657
Fax: 800-361-6984
Email: customerservice@hpsrx.com

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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). The device should not be left in place more than 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.

Please click here to download the full Instructions for Use.

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).

To contact Medicem directly, please email: usinfo@medicem.com.

References:

  1. DILAPAN-S® Instructions for Use. DSPlenus-Rev018/2020-04
  2. Dilapan-S® Issuance of Substantial Equivalence Determination. US Food and Drug Administration. 2015. 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 multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018;229:70-75.
  5. 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.
  6. 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.
  7. 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. June29-July3, 2014. Nice, France.
  8. Hruban L, Janků O, Šimetka 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.
  9. 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.