TCT 2017: Magmaris Resorbable Magnesium Scaffold (RMS) Continues to Show No Instances of Scaffold Thrombosis
Pooled Analysis of BIOSOLVE-II and BIOSOLVE-III Studies Demonstrate Consistently Low Rates of Late Lumen Loss at 12 Months
Data presented during the TCT congress on BIOTRONIK's Magmaris1 RMS provide further evidence on its continued safety and efficacy. 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.
“We now have another set of evidence where even when pooling BIOSOLVE-II and -III data, Magmaris shows zero percent definite and probable scaffold thrombosis for up to 12 months in clinical trials,” stated coordinating clinical investigator Dr. Michael Haude, professor of cardiology at Lukas Hospital, Neuss, Germany. “This adds to our understanding that approximately 95 percent of the magnesium scaffold is being resorbed within 12 months.”
During his presentation, Dr. Haude showed angiographic follow-up of a total of 97 patients from BIOSOLVE-II and -III. The pooled in-segment late lumen loss (LLL) remains low with 0.25 mm ± 0.31 mm at 12 months. These data, together with the presented data on definite or probable scaffold thrombosis (zero percent) for BIOSOLVE-II at 24 months, confirm that the RMS is a safe and effective option for patients with de novo coronary artery lesions. Moreover, the pooled target lesion failure (TLF) rate of 3.3 percent at 12 months is comparable to second-generation drug-eluting stents.
“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,” said Dr. Alexander Uhl, BIOTRONIK Vice President of Marketing, Vascular Intervention. “These data reiterate that magnesium-based resorbable technology is entirely different in both mode of action and clinical outcomes to PLLA-based bioresorbable scaffolds (BRS). We at BIOTRONIK remain committed to vessel restoration therapy based on magnesium technology.”
1 Not currently available in the United States.
2 CAUTION – Investigational device. Limited by United States law to investigational use.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.