Biotronik has announced final enrolment in the BIOMAG-I clinical trial by Michael Haude (Rheinland Klinikum, Neuss, Germany) the study’s coordinating clinical investigator and the principal investigator Javier Escaned (Hospital Universitario Clínico San Carlos, Madrid, Spain. The prospective single-arm study assesses the safety and clinical performance of Dreams 3G 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 Haude. “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 enrolment, primary endpoint data on in-scaffold late lumen loss at six-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 Alexander Uhl, president vascular Intervention at Biotronik. “Our current RMS device in the market—Magmaris—showed excellent five-year 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 third-generation device is Biotronik’s newest resorbable solution made from proprietary Biomag magnesium alloy. The implant supports the patient’s vessel for a limited period only, which is critical for vessel healing. Approximately 12 months after the implantation the magnesium is resorbed.