The strategic partnership expresses conviction and confidence in the long-term success of bioresorbable scaffolds based on valid clinical evidence. Together with clinical experts in the field and the clinical research organization MAXIS Medical, further generation of evidence within the ongoing post market clinical trial is ensured. This collaboration thereby continues to support the create evidence for claims approach.
Therapies for patients undergoing percutaneous coronary intervention currently include either the implantation of a permanent metal-based drug-eluting stent or the usage of a drug-coated balloon. A permanently implanted metal stent restricts the natural movement and function of the artery and impends further interventions. A solution to this might be bioresorbable scaffolds that disappear from the vessel, leaving a fully restored artery. The benefits clearly lie within a reduction of complex secondary cardiac procedures, preserving all future treatment options and the opportunity for vessel recovery and improved health requiring fewer procedures in a lifetime.
“B. Braun’s mission to restore and protect the health of patients around the world overlap and complement REVA’s ambition. This reflects a great fit for our strategic orientation to be part of a constructive dialog to develop future-oriented solutions in close cooperation with our customers”, says Thilo Rubart, Senior Vice President Vascular Systems, B. Braun.
“REVA Medical's 3rd generation Fantom® Encore bioresorbable coronary scaffold combines several technological advancements in both material and design, which overcomes many issues observed with other bioresorbable scaffold systems. REVA’s FANTOM II pivotal clinical trial has evaluated patient outcomes through 5 years of clinical follow-up and complete resorption of the scaffold. The results have demonstrated exceptional long term clinical outcomes as compared to current state-of-the-art drug eluting stents”, says Jeffrey Anderson, President and Chief Executive Officer of REVA Medical.
“For B. Braun the Fantom® Encore bioresorbable scaffold perfectly fits into our philosophy to leave nothing behind. Whenever a stent is inevitable, despite the great clinical success of drug-coated balloons, the bioresorbable scaffold now provides a reliable and sustainable solution, especially for those patients who require temporary physical support of the vessel”, adds Jochen Becker, Senior Vice President Global Sales & Marketing Vascular Systems, B. Braun.
About B. Braun
With over 64,000 employees in 64 countries, B. Braun is one of the world's leading manufacturers of medical devices and pharmaceutical products and services. Through constructive dialog, B. Braun develops high quality product systems and services that are both evolving and progressive - and in turn improves people's health around the world. With 31 years of expertise in supplying premium solutions for Diagnostics and Therapy in the Cath Lab, B. Braun is the global market leader for drug-coated balloon angioplasty.
About REVA Medical
REVA Medical, LLC. is a medical device company focused on the development of bioresorbable polymers for vascular applications. REVA’s mission is to restore patient health for life through the application of biomaterials in the development and sale of implantable medical devices.
REVA Medical, LLC
About MAXIS Medical
MAXIS Medical is a clinical market development company focused exclusively on emerging medical technologies. MAXIS is experienced in strategic consulting, clinical research, regulatory affairs and market development— providing a full range of services for start-up medical device companies and complete ‘wrap-around’ support for early stage needs.