First Patient Recruited for B. Braun SeQuent® Please NEO REVERSE Trial

First Patient Recruited for B. Braun SeQuent® Please NEO REVERSE Trial

Berlin, Sept., 2023 - B. Braun is proud to announce that a remarkable milestone has been achieved with the successful enrolment of the first patient in the REVERSE Trial (Randomised Trial of Drug-CoatEd Balloon Versus Drug-Eluting Stent foR Clinical OutcomeS in Patients with LargE Coronary Artery Disease).

The REVERSE trial aims to assess the safety and efficacy of SeQuent® Please NEO drug-coated balloon (DCB) treatment compared to the conventional approach that uses current-generation drug-eluting stenting (DES) for patients with large coronary artery disease. This trial is designed to determine whether the clinical outcomes of patients treated with DCB are non-inferior to those treated with permanent DES implants by reviewing the primary clinical endpoint of net adverse clinical event (NACE) within one year of the procedure of the trial subjects.

Founded in 1839, B. Braun has continually evolved into a global manufacturer and provider of innovative, high-quality healthcare products and services, setting industry standards. SeQuent® Please NEO, B. Braun developed for percutaneous coronary intervention (PCI) is coated with paclitaxel, a drug proven to inhibit the proliferation of smooth muscle cells, reducing the risk of restenosis. 

Professor Eun-Seok Shin, Ulsan University Hospital, South Korea, the Chief Principal Investigator for the REVERSE trial and leading the study research team, expressed her excitement, stating, “The REVERSE trial is a large, international, randomised, multicenter study which will help clinicians in understanding the effective treatment strategy for de novo large coronary vessel disease. Our goal is to enrol 1436 patients across 20 centres in South Korea, Malaysia, Singapore, and Taiwan over the next 2 years. The data collected from the trial will provide crucial clinical evidence that will help shape the medical practice in treating large coronary vessel disease.” 

“B. Braun’s SeQuent® Please NEO is the most extensively investigated drug-coated balloon, with over 110 publications substantiating its performance in different coronary artery treatments. I am thrilled that Professor Shin recruited the first patient in the study. I’m deeply appreciative of the unwavering commitment from everyone involved in executing this trial.” said Dr. Thilo Rubart, Senior Vice President Vascular Systems of B. Braun in Berlin.

The B. Braun Asia Pacific President, Mr Lam Chee Hong, commented, “B. Braun's dedication to advancing healthcare through innovative products extends worldwide, and we are proud to bring our products to patients around the globe. Our dedication to conducting the REVERSE Trial in the Asia Pacific region underscores our recognition of its unique patient diversity and the wealth of valuable data it provides. We believe this initiative will benefit patients in Asia Pacific and contribute to improving healthcare solutions worldwide.”

B. Braun remains steadfast in fostering constructive dialog and collaboration with clinical experts and partners to find evolving and progressive solutions for patients worldwide and to set guiding standards for the healthcare industry.

For more information about the REVERSE trial, please visit ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT05846893 .

 

About B. Braun

B. Braun is one of the world’s leading medical technology companies with over 65,000 employees in 64 countries. We aim to protect and improve the health of people around the world. Through Sharing Expertise and the power of technology we drive advancements in health care. As a true partner we develop smart solutions and set standards to improve health care.

Contact

Philip Steen, MD

Medical Officer

B. Braun, Berlin, Germany

Philip.steen@bbraun.com

Eng Hooi Sian, Ph.D, F(ACHI)

Study Manager

B. Braun, Asia Pacific, Malaysia

Hooi.eng@bbraun.com

Professor Eun-Seok Shin, the Chief Principal Investigator for the REVERSE trial, and her study team of Ulsan University Hospital, South Korea