BIOTRONIK Successfully Concludes Magmaris 2,000 Program at Two Years Since CE Mark

Ever since its CE launch in June 2016, BIOTRONIK’s Magmaris has been implanted by more than 650 physicians in over 350 hospitals across 45 countries. As part of its Magnesium 2,000 program, a post-market evaluation program, more than 2,000 Magmaris cases were evaluated in a range of performance criteria.

An evaluation of the “4Ps” of implantation protocol (patient selection, proper sizing, pre-dilatation and post-dilatation) indicates that Magmaris was predominately chosen due to the expected return of vasomotion of the scaffolded vessel segment (55%) as well as patient’s life expectancy to be at least five years (67%). Lesions treated were discrete short lesions (36%), de novo lesions (80%), lesions with low calcification (67%), and lesions with low/no vessel tortuosity (51%). Pre-dilatation was performed in 95% of cases while in 87% of cases, physicians performed post-dilatation.

The scaffold’s acute performance was evaluated in bench tests and compared to physicians’ feedback from the Magnesium 2,000 program. The results show that Magmaris demonstrates better crossability, trackability and pushability.¹

“Magmaris’s acute performance ratings show an improvement in scaffold technology compared to previous polymeric scaffold experiences,” said Dr. Stefano Galli, Cardiologist, Laboratorio di Emodinamica, Centro Cardiologico Monzino, Milan, Italy. “We believe that Magmaris’s robust Magnesium backbone is key in offering these favorable mechanical properties.”

Recent presentation² of the BIOSOLVE-IV trial has shown that when considering the Instruction for Use (IFU) and indication for use, Magmaris shows performance rates at 12 months that are comparable to second-generation drug-eluting stents.

“The results of the Magnesium 2,000 program supplement the very positive results of our clinical program,” stated Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “Within the first two years since its CE marking, Magmaris has already benefited many thousands of patients and clinical evidence for its safety and efficacy continues to grow.”

References:

^{1Absorb, Abbott}

^{2Verheye S. Biosolve-IV: 12-month follow-up of the safety and performance of the resorbable magnesium scaffold, Magmaris in a real-world setting - first 200 subjects. Presented at: euroPCR; May 22, 2018; Paris, France. ClincialTrials.gov: NCT 02817802}