Cervilenz Inc. Reduces Premature Birth Risk with Simple Test

Since its commercial debut in 2011, the CerviLenz device, which is designed to help healthcare practitioners identify and manage pregnant women at high risk for premature birth has been shown to be nearly 100 percent effective in two recent clinical studies.

Manufactured and marketed by Chagrin Falls, Ohio-based Cervilenz, Inc., the device measures the vaginal cervical length and quickly identifies women at high risk for premature birth. Premature birth is the leading cause of death for newborns in the United States, and cervical length is considered the single best indicator for premature birth risk. To date, measurements have been made with transvaginal ultrasound (TVU).

The CerviLenz device’s advantage is that it can be used by any healthcare practitioner trained to perform a speculum exam in any healthcare setting. The disposable, single-use device is cost-effective and allows the physician or midwife to begin treatment more quickly.

Both clinical studies were presented as part of the “Prevention of Prematurity and Care of the Premature” scientific session at the 10th World Congress of Maternal and Neonatal Health in Rome in December 2011.

Premature birth, which affects 13 million babies globally each year, has been named a public health epidemic and was the sole topic of the session. In this session, Gian Carlo Di Renzo, MD, PhD and president of the Congress, addressed the condition’s risk factors and introduced the CerviLenz device as a cost-effective innovation with potential to improve maternity care worldwide.

Dr. Di Renzo declared that the device shows “great promise to identify patients at risk for preterm delivery as well as those in real preterm labor” and shared data from his recent clinical evaluation. At each of the 50 patients’ mid-gestation pre-natal visits, cervical length was checked with the traditional transvaginal ultrasound (TVU) and the CerviLenz device. Each test was performed by two different examiners blinded to the other result.

“Our data show 100 percent agreement,” Dr. Di Renzo, said in a press release. “Both TVU and CerviLenz measurements identified all of the patients with a cervical length of less than 30 millimeters (3 centimeters) and the correlation coefficient was excellent. I am very pleased with the performance of this new device to identify high risk patients so they can be treated appropriately with progesterone therapy to prevent preterm delivery.”

Another study presented at the Congress comes from Justin Lavin, MD and professor emeritus of obstetrics and gynecology at Northeast Ohio Medical University, evaluated pregnant women with regular contractions between 22 and 34 weeks gestation.

This study, which took place at Akron General Medical Center in Akron, Ohio, followed 144 pregnant women presenting with regular contractions in the late second and early third trimesters. The CerviLenz device was used to measure cervical length and if a patient measured 25 millimeters (2.5 cm) or more ruled out delivery within seven days with 100 percent accuracy and delivery before 34 weeks with 97 percent accuracy.

“These data show similar results to published data with transvaginal ultrasound assessment of cervical length to rule out suspected premature labor,” Dr. Lavin said in a press release. “The CerviLenz device holds great promise as a tool to help physicians make decisions in this challenging clinical situation.”

Cervilenz, Inc. presented its products and technologies at OneMedForum SF 2012.

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