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.