Medistim announces partnership with ROMA-Women Trial

Posted on
June 5, 2023
by Medistim

Monday, June 5th, Medistim announces partnership with groundbreaking cardiac surgery trial exclusively dedicated to women.

Medistim is pleased to announce its partnership with ROMA-Women, a groundbreaking cardiac surgery trial that is specifically focused on women. Historically, cardiovascular research and treatment protocols have primarily focused on men, leaving women underrepresented in clinical studies and potentially receiving suboptimal care. Recognizing this disparity, Medistim has joined forces with the trial to champion gender-specific healthcare advancements.

The multicenter randomized clinical trial, ROMA-Women, will enroll about 2,000 women, studying the use of single versus multiple arterial grafts in coronary artery bypass (CABG) surgery. The trial is spearheaded by renowned experts in the field of cardiac surgery, including principal investigators Mario Gaudino, Professor at Weill Cornell Medicine, USA, and Stephen Fremes, Professor at Sunnybrook Health Sciences, Canada. More than 100 centers across the world are expected to participate. The trial is an extension of the ongoing ROMA trial and has already enrolled about 700 women.

ROMA-Women aims to address the unique cardiovascular needs and challenges faced by women. Compared to men, women are referred for CABG at an older age and have more frequently diabetes, hypertension, and dyslipidemia. From a surgical perspective, the CABG operation is generally more complex in women because of smaller and more spastic coronary arteries than men. Hence, it is believed that graft assessment may be even more important in women, and in this trial, graft patency will be assessed with Medistim’s Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) technologies.

“We are thrilled to collaborate with this pioneering cardiac surgery trial exclusively dedicated to women,” says Kari E. Krogstad, President and CEO at Medistim. “In this trial, we will contribute with our expertise, resources, and innovative technologies. At Medistim, we are passionate about advancing patient care and empowering women in all parts of the patient care value chain. This partnership not only aligns with our company culture but also embodies our commitment to driving innovation and addressing the unmet needs of diverse patient populations.”

“We are very grateful to Medistim for the partnership and support. ROMA-Women will not only improve women’s health and outcomes after bypass surgery, but also has the potential to revolutionize the approach to generating evidence in women and patients who have traditionally not been adequately represented in clinical trials. This is an enormous and ambitious effort, and we need all the help possible – Medistim stepping in and being at our side is instrumental in the success of the trial,” says lead investigator Mario Gaudino.

Read more about the ROMA-Women Trial