TCT 2017: Pooled analysis of Magmaris studies continue to show no instances of scaffold thrombosis at 12 months


Data presented during the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Denver, USA), according to a press release, provide further evidence of the safety and efficacy of Biotronik’s bioresorbable scaffold Magmaris.

Pooled 12-month data from the BIOSOLVE-II and BIOSOLVE-III clinical trials highlight high procedural success and the continuous absence of late definite or probable scaffold thrombosis.

During a presentation at TCT, Michael Haude (Lukas Hospital, Neuss, Germany) showed angiographic follow-up of a total of 97 patients from BIOSOLVE-II and -III. The pooled in-segment late lumen loss remained low with 0.25±0.31mm at 12 months. The press release states that these data, together with the presented data on definite or probable scaffold thrombosis (0%) for BIOSOLVE-II at 24 months, confirm that the scaffold is a safe and effective option for patients with de novo coronary artery lesions. Moreover, the pooled target lesion failure rate of 3.3% at 12 months is comparable to second-generation drug-eluting stents.

Haude comments: “We now have another set of evidence where even when pooling BIOSOLVE-II and -III data, Magmaris shows 0% definite and probable scaffold thrombosis for up to 12 months in clinical trials. This adds to our understanding that approximately 95% of the magnesium scaffold is being resorbed within 12 months.”

“At a time when questions have been raised about poly-L-lactide (PLLA) scaffolds, we are pleased to once again report safe and efficacious results for Magmaris. These data reiterate that magnesium-based resorbable technology is entirely different in both mode of action and clinical outcomes to PLLA-based bioresorbable scaffolds. We at Biotronik remain committed to vessel restoration therapy based on magnesium technology,” comments Alexander Uhl, Biotronik vice president of Marketing, Vascular Intervention.


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