Following Receipt of FDA Breakthrough Device Designation, Market Leading Global Organizations Strengthen their Cooperation to Navigate U.S. Regulatory Pathway
BETHLEHEM, Pa., March 31, 2021 /PRNewswire/ — B. Braun Interventional Systems Inc. (BIS) announced today that they will collaborate with Infraredx, a Nipro Company, to accelerate the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial for the B. Braun SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter, which received FDA Breakthrough Device Designation in late 2019. This announcement furthers the long-term global cooperation between the B. Braun Group of Companies and Japan-based Nipro Corporation to advance coronary artery disease management.
The companies are ideally positioned to leverage shared resources to accelerate the initiation of the U.S. clinical trial of the SeQuent Please ReX to study the treatment of coronary in-stent restenosis (ISR), which is defined as the gradual re-narrowing of a coronary artery following stent implantation. Despite a significant reduction in ISR when using a drug-eluting stent (DES), a recent study has shown that ISR represents approximately 10% of all percutaneous coronary interventions in the U.S.1
With a shared interest in the study, BIS and Infraredx will pool clinical expertise and financial resources to execute the U.S. study.
“B. Braun and Nipro have worked together over the last decade to arm vascular specialists in Europe and Asia with alternative therapies for coronary interventions,” said Nozomu Fujita, President & CEO of Infraredx, a Nipro Company. “Our decision to also align the resources of our U.S. entities will accelerate how quickly U.S. Interventionalists will be able to access the SeQuent Please ReX technology for U.S. clinical trials.”
Outside of the U.S., B. Braun has successfully sold more than one million SeQuent Please Drug Coated PTCA Balloon Catheters. The SeQuent Please ReX, a variation to the current SeQuent Please portfolio sold outside the United States, was developed exclusively for the U.S. market, and represents the most recent development in the B. Braun DCB portfolio.
“Over the last decade, together with Nipro, we have been able to develop the market for coronary drug-coated balloons by delivering high-quality clinical evidence and optimal physician and patient access,” said Dr. Philip Steen, Director of Medical, Scientific & Regulatory Affairs, B. Braun Melsungen AG Vascular Systems. “Aligning with Infraredx to work toward bringing the SeQuent Please Technology to the U.S. marketplace through the U.S. IDE process is a logical next step to address an important unmet clinical need.” Dr. Steen, an Interventional Cardiologist by training, had used the SeQuent Please portfolio to treat patients in Germany prior to joining B. Braun Melsungen AG Vascular Systems as a senior leader and strategic clinical advisor to the organization.
The SeQuent Please drug-coated balloons for the treatment of coronary artery disease is supported by significant clinical data. The clinical evidence is underlined in more than 19 randomized controlled trials.2
The B. Braun Group of Companies is the worldwide market leader in drug-coated PTCA technology. BIS received FDA Breakthrough Designation for the SeQuent Please ReX in 2019.
About B. Braun Interventional Systems
B. Braun Interventional Systems offers interventional solutions designed with the patient in mind. Many of the products offered have been developed in response to the needs of physicians, technicians, and nurses. The company is committed to delivering safety, precision and convenience to interventional procedures. B. Braun Interventional Systems Inc. is part of the B. Braun Group of Companies in the U.S., which is headquartered in Bethlehem, Pa., and includes B. Braun Medical Inc., Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Interventional Systems Inc., visit www.bisusa.org/about-us and connect with B. Braun Interventional Systems on LinkedIn.
About Infraredx, a Nipro Company
Infraredx, a Nipro company, is advancing the diagnosis and management of coronary artery disease by providing cardiologists with the most precise imaging tools required to predict and ultimately prevent heart attacks. Infraredx, a Nipro Company is dedicated to advancing this important field of research and conducting landmark clinical trials to transform how we view and treat heart disease. For more information about the Makoto™ Intravascular Imaging System or the OKAY® II Y-Connector please visit www.infraredx.com and connect with Infraredx on Twitter and LinkedIn.
[1] Moussa ID et al. JACC. 2020; 76(13): 1522-1531. [2] Scheller B et al. JACC. 2020 ; 75(9): 1017-1028.
SOURCE B. Braun Medical Inc.
