“PTB” is a growing global healthcare crisis and is the leading cause of infant death and morbidity within the first month of life. The 2010 “Premature Birth Report Card”, issued by the March of Dimes, reports that 12.3% of all pregnancies in the U.S. end in preterm delivery (birth prior to 37 weeks gestation).
As many as 1/2 of these preterm deliveries are problematic as a result of incompetent cervix and various other conditions, including: known cases of organ and / or tissue compromise; pregnancies involving multiple fetuses, and; a growing number of women having children both later and earlier in life. Existing treatment options for these conditions are limited, invasive and costly (many now being rejected by Payers, since none demonstrate proven efficacy).
In summary, each year, more than 550,000 infants are born preterm in the U.S. alone. The March of Dimes and World Healthcare Organization report that PTB costs Payers an average of $79,000 / child, and can sometimes top $1,000,000 in more extreme cases.
Beyond the immeasurable human tragedy, the global socioeconomic consequences of Preterm Birth are estimated to exceed $52 billion annually. In addition, conditions which may cause PTB can also contribute to Premature Rupture of Membranes “PROM”, as can other maternal illnesses, including Chorioamnionitis (an infection of the amniotic membranes) from a variety of organisms which weaken the membranes, and Polyhydramnios (too much amniotic fluid), which overtaxes the membranes’ properties such as to risk PROM.
When these membranes rupture (which also causes the expulsion of the sterile amniotic fluids), there is only about 24 hours in which to successfully treat the patient and / or complete the birthing event before the risk of serious infection becomes a concern.
Overall infant mortality from PROM is 5%, with infection being the most significant factor to the cause of death. Infant mortality from PROM for PTB infants is 30% (infants from 28 to 37 weeks gestation, whose mothers’ membranes ruptured before the onset of labor).
CSD is designed to treat all these conditions from the earliest indication and throughout the pregnancy, with a simple, cost effective device which Payers are sure to invite (as our collaboration with UnitedHealth Group strongly evidences); and which may also be used in the late stage support of cerclage, affording the attending physician the opportunity of preserving the cervix and further extending the delivery.