New Data Validates the Efficacy of the CerviLenz Device for Cervical Length Screening
New published study on the CerviLenz device.
- (1888PressRelease) July 26, 2013 - A study to evaluate the CerviLenz device was conducted at the University of Perugia, in Italy. Published in the June issue of Minerva Ginecologica, Effectiveness of a New Cervicometer in Evaluating the Risk of Preterm Delivery,1 provides additional support for the clinical utility of the CerviLenz device as a screening tool for preterm birth risk assessment. The authors conclude that, "The cervicometer proved to be a reliable and easy to use device to detect a normal or short cervix, with contained healthcare costs."
Originally presented at the 2013 Society for Maternal-Fetal Medicine Annual Meeting, the study compared CerviLenz and transvaginal ultrasound measurements of cervical length in asymptomatic, singleton pregnancies mid-pregnancy. The results "showed 100% concordance and a correlation between the two techniques of 0.94."
Dr. Gian Carlo Di Renzo, Professor and Chairman Dept. of Ob/Gyn, Director Centre for Perinatal and Reproductive Medicine, The University of Perugia, Italy and the senior author of the study, commented on the results saying, "Preterm birth is a global health issue. I travel the world lecturing on critical issues in obstetrics, and the CerviLenz device holds great promise across all types of healthcare systems. This device is a simple, low cost solution for screening all pregnancies for short cervix to help reduce the rate of preterm birth."
The CerviLenz device is used by healthcare professionals to measure the length of a woman's cervix while she is pregnant. A short cervix during pregnancy is known to be the best predictor of preterm birth risk and a key factor in determining whether intervention is necessary. The CerviLenz device, invented by an obstetrician, can be used in any healthcare setting, by a trained physician, midwife, or nurse.
1Porcaro G, Clerici G, Romanelli M, et al. Effectiveness of a new cervicometer in evaluating the risk of preterm delivery. Minerva Ginecol 2013 June;65(3):327-330.
About Cervilenz Inc.
Cervilenz Inc. manufactures and markets the CerviLenz® device- an innovative medical device that measures vaginal cervical length to help physicians identify and manage pregnant women at high risk for preterm birth. Founded in 2008, Cervilenz Inc. is dedicated to making a difference in the world of prematurity. The company headquarters is in Chagrin Falls, a suburb of Cleveland, Ohio. CERVILENZ is a registered trademark of the Company in the U.S. The trademark CERVILENZ is also registered via a community trademark application in the European Union. The CerviLenz device is classified under 21 CFR 884.4530(2)(a.) as a 510(k) exempt device and has its CE Mark and ISO 13485 Certification for international distribution. For more information, visit www.cervilenz.com or contact Melanie Sweeney, Vice President of Marketing (440.337.4253 or melanie ( @ ) cervilenz dot com) dot
About Preterm Birth
Preterm birth is a worldwide public health epidemic and the leading cause of infant death. Nearly 15 million babies are born preterm every year. In the United States, preterm birth affects 12% of pregnancies and its annual economic toll is $26.2 billion in health care and related costs.
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