WASHINGTON, DC, US and BUELACH, Switzerland, November 1, 2016 – BIOTRONIK today presented users’ first experiences with Magmaris1
during a symposium at TCT. The BIOSOLVE-II trial had previously established the safety and clinical performance of Magmaris. In June 2016, the first clinically proven magnesium-based resorbable scaffold (BRS) received CE approval.At the symposium, physicians discussed interim results of BIOTRONIK’s Magnesium 1,000 program. In order to help first implanters gain experience in the most effective possible use of Magmaris, the program requires participating physicians to record each implantation. To date, over 500 implantations have taken place in 25 countries. Physicians at the symposium further discussed why optimal patient profile and lesion selection is crucial when deciding whether to use BRS. “Cautious patient selection is key, and attention must be paid to lesion length, size and type to insure the best possible outcomes with Magmaris,” commented Dr. Jacques Koolen, Catharina Hospital, Eindhoven, Netherlands. “Younger patients with de novo lesions in vessels with a diameter not smaller than 2.7 mm are ideally suited for Magmaris. Evidence from trials and clinical practice demonstrate that with the right lesion, Magmaris leads to a simple and viable procedure which provides a very good outcome for the patient. This was established by the complete absence of scaffold thrombosis at 12 months observed in the BIOSOLVE-II trial. The upcoming BIOSOLVE-IV trial will shed more light on Magmaris’s efficacy in a wider patient population.”
- Not currently available in the United States.
- CAUTION – Investigational device. Limited by United States law to investigational use.