New Independent Research on CerviLenz Presented at SMFM Annual Meeting
Cervilenz Inc. is pleased to announce presentation of new data from an independent study at the Society for Maternal-Fetal Medicine (SMFM) Annual Meeting in San Francisco on February 15th.
- (1888PressRelease) February 13, 2013 - The study - "CerviLenz and ultrasound evaluation of cervimetry: a comparative study" 1 - adds to the body of evidence validating the efficacy of the CerviLenz® device as a first line screen for generalists to identify patients who may benefit from referral for transvaginal ultrasound (TVU).
The independent research was conducted in the clinical departments of Dr. Gian Carlo Di Renzo at the University of Perugia and Dr. Fabio Facchinetti at the University of Modena and Reggio Emilia in Italy.
"The results of this study show that CerviLenz and TVU measurements of cervical length were highly correlated with high sensitivity, specificity, and negative predictive value in both asymptomatic and symptomatic patients,"said Dr. Francesca Ferrari, the lead author.
The conclusion of the abstract is: "Given cost and turnaround time with TVU evaluation, CerviLenz represents a first-line clinical tool to screen women not requiring further investigation with TVU."1
Pregnant women with a prematurely short cervix are at high risk for preterm birth. There is compelling evidence that vaginal progesterone reduces preterm birth and improves infant outcomes for patients with a mid-pregnancy short cervix. In May 2012, SMFM published a Clinical Guideline2 recommending this intervention. The American College of Obstetricians and Gynecologists (ACOG) published a Practice Bulletin3 in October with parallel recommendations.
Both of these publications recognize universal cervical length screening for routine singletons as a reasonable strategy to help prevent preterm birth by identifying patients for vaginal progesterone treatment.
Dean Koch, President and CEO of Cervilenz Inc., commented, "Obstetricians are looking for an efficient way to add cervical length screening to routine prenatal care in their busy practices. In an independent survey of obstetricians, 95% see a role for CerviLenz in supporting adoption of universal cervical length screening, 80% in their own practice. Compared to the significant barriers of cost and time for TVU screening, CerviLenz is viewed as allowing selective and appropriate use of TVU in the patients most likely to benefit. "
The CerviLenz study is being presented during Poster Session III, from 10 am to noon in the Grand Ballroom at the Hilton San Francisco Union Square. Cervilenz Inc. is also exhibiting at the meeting at Booth #103.
1Ferrari F, Facchinetti F, Porcaro, G et al. CerviLenz and ultrasound evaluation of cervimetry: a comparative study. Am J Obstet Gynecol 2013;January Supplement:S209. Poster presented at 33rd Annual Meeting, Society for Maternal-Fetal Medicine.
2Society for Maternal-Fetal Medicine Publications Committee with the assistance of Vincenzo Berghella, MD. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol 2012;206:376-386.
3American College of Obstetricians and Gynecologists (ACOG). ACOG practice bulletin no.130: prediction and prevention of preterm birth. Obstet Gynecol 2012 Oct;120(4):964-73.
About Cervilenz Inc.
Cervilenz Inc. manufactures and markets the CerviLenz® device- an innovative medical device that measures cervical length to help physicians identify and manage pregnant women at high risk for preterm birth. Dedicated to making a difference in the world of prematurity, Cervilenz Inc. donates a portion of revenue to charitable organizations that advance maternal and fetal health globally. Founded in 2008, the company headquarters is in Chagrin Falls, a suburb of Cleveland, Ohio. The CerviLenz device is cleared for sale in the U.S. 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 13 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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