B Braun Interventional Systems has announced a collaboration with Infraredx to accelerate the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial for the 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 US 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, the companies said in a press release. The two organisations will pool clinical expertise and financial resources to execute the US 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 US entities will accelerate how quickly U.S. Interventionalists will be able to access the SeQuent Please ReX technology for US clinical trials.”
“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 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 US marketplace through the US IDE process is a logical next step to address an important unmet clinical need.” 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 organisation.
The SeQuent Please drug-coated balloons for the treatment of coronary artery disease is supported by significant clinical data.