In December 2020, B. Braun Vascular Systems produced and sold its one millionth drug coated balloon catheter.

“We would like to use this opportunity to thank everyone involved in this fantastic success for their great performance," said Jochen Becker, Senior Vice President Global Sales & Marketing at B. Braun Vascular Systems. "Together, we have created and developed this new market segment and achieved a remarkable market-leading position worldwide."

The drug coated coronary balloon catheter, SeQuent® Please, is produced at the B. Braun factory site in Berlin and has a global market share of approximately 70 percent today. It is a success story for B. Braun and also an outstanding example of Sharing Expertise. 

How did  this happen? In 2004, Professor Ulrich Speck from the Charité University Hospital in Berlin and Professor Bruno Scheller from Homburg/Saarland, were looking for an industrial partner to develop a novel medical product for coronary balloon catheters. Such products dilate narrowed coronary arteries, allowing restoration of a blood flow, sufficient oxygen supply to the heart and therefore the prevention or treatment of a heart attack.  

Initial experiments by the two physicians saw to coat balloon catheters with a drug to significantly reduce the risk of repeat vessel narrowing or occlusion. Through partnering with B. Braun, the physicians accessed the necessary expertise to turn this novel innovation into a production-ready, approved and commercially viable product. In 2006, the breakthrough clinical trial, PACCOCATH ISR I, published in the renowned "New England Journal of Medicine" demonstrated excellent clinical results. The proven safety and efficacy of SeQuent® Please from this trial convinced the medical community, too.

Challenges on the way to market success

Launched in 2009, SeQuent® Please  received a lot of public and professional attention, but due to its novelty, the market required development. These were challenging years for B. Braun Vascular Systems product representatives but they paid off. In 2014, SeQuent® Please received the highest evidence class IA from the European Society of Cardiology (ESC) for the treatment of ‘in-stent restenosis’ and is now successfully used in many parts of the world, especially in Europe and Asia. "The road has been long, but we have always believed in the product and the technology," explains Becker. The investment has truly paid off. In 2009, 10,000 balloon catheters were sold, today approximately 200,000 units are sold worldwide each year and the market continues to grow.

"Our next target is the US market," adds Sebastian Schwethelm, Product Manager Coronary Angioplasty. A registration trial is planned to start in July.

The Berlin-based company has its sights not only set on new markets. There is already a successor product: SeQuent® SCB. A new drug coated balloon catheter coated with the drug Sirolimus, which has been used in drug eluting stents for many years. Initial studies to establish the safety and efficacy profile of this new product have already begun. After all, a comprehensive study, powered with clinical endpoints, is the basis for a successful market approach.