Cervical Ripening

CVX-Ripe® is a soft silicone, dual-balloon transcervical ripening catheter intended to provide gentle mechanical pressure to improve the favorability of the cervix of pregnant patients at term gestation, where induction of labor is medically indicated.

PRODUCT DESCRIPTION

CVX-Ripe® is a silicone, dual-balloon, transcervical ripening catheter with stylet.

FEATURES

• Conical shaped balloons, designed with no gap in between, form an hourglass shape when placed in the patient.
• Soft silicone "nose" and catheter body combined with a pliable stylet to balance safety with ease of insertion.
• Catheter is packaged with a 20 mL syringe for clinician convenience.
• Luer-activated inflation ports for easy inflation.
• Catheter tubing is 18 French.
• Not manufactured with Latex, DEHP or BPA.
• 5 year shelf life.

INDICATIONS

CVX-Ripe® is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

CONTRAINDICATIONS

• Patients with any contraindication to spontaneous or induced labor.
• Patients who may simultaneously receive prostaglandin administration.
• Any fetal presentation, position or orientation that contraindicates vaginal delivery.
• Any abnormal placental or umbilical cord features that contraindicate vaginal delivery, including, but not limited to, placenta previa, placenta percreta and/or vasa previa.
• Any prior uterine incision(s) that contraindicates spontaneous or induced labor and/or vaginal delivery.
• Ruptured amniotic membranes.
• Patients with an active genital tract infection such as genital herpes.
• Cervical cancer.
• Abnormal fetal heart rate tracing.
• Multiple gestational pregnancy.