BIOTRONIK's New Absorbable Magnesium Scaffold Achieves Major Milestone in BIOMAG-I Clinical Trial
The Multi-Center Study Will Evaluate the Safety and Performance of the Next Generation of BIOTRONIK’s Resorbable Magnesium Scaffold
BIOTRONIK today announced final enrollment in the BIOMAG-I clinical trial1 by Prof. Michael Haude, Germany, the study’s coordinating clinical investigator and the principal investigator Prof. Javier Escaned, Spain. The prospective single-arm study assesses the safety and clinical performance of DREAMS 3G, the next generation resorbable magnesium scaffold (RMS).
“Based on my extensive experience with resorbable magnesium scaffolds, DREAMS 3G represents a very promising evolution for resorbable technology. With its larger size matrix, thinner struts and improved mechanical performance, DREAMS 3G has the potential to provide a broader range of clinical benefits than previously available scaffolds”, said Prof. Michael Haude, Rheinland Klinikum, Neuss, Germany. “The BIOMAG-I study is investigating whether these design improvements will translate into the expected clinical benefits. The study has now achieved a major milestone by completing the enrollment, primary endpoint data on in-scaffold late lumen loss at 6-month follow up are intended to be presented later this year”.
A total of 14 clinics in eight European countries are taking part in the BIOMAG-I clinical trial. The patient cohort includes 116 patients aged between 18 and 80 years with single de novo lesions in up to two coronary arteries. The study will run for a total of three years, assessing the primary endpoint of in-scaffold late lumen loss at six months, with follow-ups at 12, 24 and 36 months.
“Our resorbable magnesium scaffold technology for coronary artery disease has proven over recent years to be a valuable and safe alternative treatment option to permanent cobalt-chromium drug eluting stents (DES),” said Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. “Our current RMS device in the market - Magmaris - showed excellent 5y clinical outcomes, comparable with contemporary drug eluting stents. With our next RMS generation, we are confident that we will be able to provide a competitive treatment alternative to DES, solving the shortcomings of current DES permanent implants providing all the benefits of a ´leave nothing behind´ strategy. We expect this device to set the future standard for resorbable technology.”
Following the Magmaris® RMS, the DREAMS 3rd generation device is BIOTRONIK’s newest resorbable solution. The scaffold is made from the BIOTRONIK’s proprietary BIOmag® magnesium alloy for improved mechanical properties2. The implant supports the patient’s vessel for a limited period only, which is critical for vessel healing. Approximately twelve months after the implantation the magnesium is resorbed. Compared to its predecessor, the DREAMS 3G RMS provides a larger portfolio of 15 sizes to enable the treatment of a broader range of vessels and patients. The new scaffold also has thinner struts and a new marker concept for better visibility2.
1 BIOMAG-I FIM trial, ClinicalTrialsgov: NCT04157156.
2 BIOTRONIK data on file
Magmaris, BIOmag and DREAMS 3G are trademarks or registered trademarks of the BIOTRONIK Group of Companies.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.