Clinical Innovations Helps Labor And Delivery Specialists Accurately Detect Premature Membrane Ruptures Using ROM Plus

SALT LAKE CITY--(BUSINESS WIRE)--Clinical Innovations is the largest medical device company exclusively focused on labor and delivery, including the ROM Plus®, a rupture of membranes (ROM) diagnostic test, which provides immediate results to help minimize potential risks to expectant mothers and their babies. The device’s accuracy and ease of use provides a less invasive and more efficient alternative to traditional ROM detection methods used for more than 60 years, according to two new peer-reviewed clinical research papers recently published in Clinical Medicine Insights: Reproductive Health and Medical Devices: Evidence and Research.

“Rupture of membranes is one of the most common diagnostic dilemmas in obstetrics, affecting up to 10 percent of pregnancies. By helping labor and delivery providers accurately detect ruptured membranes, ROM Plus® can help identify or minimize potential complications.”

Membrane rupture “can occur at any gestational age and presents a particularly serious clinical problem if it occurs prior to 37 weeks’ gestation, where it is responsible for [up to 40 percent] of preterm births,” according to new research from Clinical Medicine Insights: Reproductive Health. The ROM Plus’ point-of-care test uses a noninvasive approach to detect proteins found in significant concentrations in amniotic fluid. The research shows that ROM Plus® outperforms more traditional testing in terms of sensitivity, specificity, and accuracy, allowing for more timely diagnosis and gestational age-specific intervention.

Traditionally, other ROM tests can be invasive, requiring a speculum and microscope, which often produces inaccurate results and can expose mothers and babies to added risk. With 99 percent sensitivity, ROM Plus® is a quick, painless, and effective solution. The test’s rapid results support better “clinical decision making, improved patient care, and greater patient satisfaction, all of which lead to better clinical outcomes,” according to a new paper in Medical Devices: Evidence and Research, describing the usage, procedures and clinical characterization of the device.

“Our mission at Clinical Innovations is to develop safe, reliable and innovative solutions to improve the lives of mothers and their babies,” said Dr. Ross McQuivey, chief medical officer for Clinical Innovations. “Rupture of membranes is one of the most common diagnostic dilemmas in obstetrics, affecting up to 10 percent of pregnancies. By helping labor and delivery providers accurately detect ruptured membranes, ROM Plus® can help identify or minimize potential complications.”

As a market leader in medical devices for labor and delivery, Clinical Innovations helps mothers and babies in more than 75 countries around the world. ROM Plus® is a critical part of Clinical Innovations’ growing product portfolio, including the Koala® Intrauterine Pressure Catheter, Kiwi® Vacuum-Assisted Delivery System and other industry-changing specialty devices.

Clinical Innovations is a member of Pritzker Group Private Capital’s family of companies.

About Clinical Innovations

Clinical Innovations is the largest medical device company exclusively focused on labor and delivery. Already a market leader in several categories with products such as the Koala® Intrauterine Pressure Catheter; Kiwi® Vacuum-Assisted Delivery System; ROM Plus® Rupture of Membranes Test; traxi^® Panniculus Retractor and ClearView Uterine Manipulator. Clinical Innovations is expanding its global presence while directly researching and developing state-of-the-art technologies and innovative medical devices that fulfill its mission of improving the lives of mothers and their babies throughout the world. Clinical Innovations is a Pritzker Group company. For more information, visit clinicalinnovations.com.

About Pritzker Group

Pritzker Group, led by Tony and J.B. Pritzker, has three principal investment teams: Private Capital, which acquires and operates leading North America-based companies; Venture Capital, which provides early-stage and growth venture funding to technology companies throughout the United States; and Asset Management, which partners with top-performing investment managers across global public markets.

Pritzker Group Private Capital acquires North America-based middle-market companies with leading positions in the manufactured products, services and healthcare sectors. The firm’s permanent, proprietary capital base allows for efficient decision making, broad flexibility with transaction structure and investment horizon, and alignment with management teams focused on creating long-term value. Pritzker Group brings significant resources, expertise and credibility in building businesses and is an ideal partner for entrepreneur- and family-owned companies. For more information, visit pritzkergroup.com.