• Superiority of BIOTRONIK’s Magmaris Resorbable Magnesium Scaffold (RMS) in Scaffold Thrombosis shown versus Abbott’s Absorb Bioresorbable Vascular Scaffold in Largest Patient Cohort to Date

    BIOSOLVE-IV Registry one-year follow up data, analyzing 2,066 patients showed Superiority of BIOTRONIK’s Magmaris Resorbable Magnesium Scaffold (RMS) versus Abbott’s Absorb Bioresorbable Vascular Scaffold in Scaffold Thrombosis* 

    Superiority of the Magmaris® sirolimus-eluting bioresorbable magnesium scaffold with regard to probable or definite scaffold thrombosis compared to a historical control group of Absorb scaffold data was demonstrated for the first time in a prospective, powered secondary endpoint in the BIOSOLVE-IV trial.1 The new full-cohort one-year results were presented at TCT and confirm the safety and performance of the Magmaris® scaffold in a larger cohort. Of particular note is the target lesion failure2 rate of 5.0% and a definite / probable scaffold thrombosis rate of 0.8% at 12 months, confirming the very good safety profile from the first cohort with 1,075 patients. The new data was presented by Prof. Dr. Johan Bennett, Coronary Interventionalist at the University Hospitals Leuven in Belgium.3

    “The results of the BIOSOLVE-IV study confirm that the Magmaris scaffold is safe and comparable to leading second-generation drug-eluting stents on the market. Importantly, the Magmaris scaffold also proves, for the first time, powered superiority to the Absorb scaffold for definite and probable scaffold thrombosis, an important landmark after the Absorb scaffold raised concerns with notably high rates of scaffold thrombosis compared to contemporary DES,” said Prof. Dr. Johan Bennett, one of the registry’s principal investigators. “We are excited to see continuous low TLF rates for this bioresorbable scaffold – now in larger and more diverse patient groups.”

    The recent positive outcomes complement previous BIOSOLVE-IV results such as the first cohort’s promising 12-month data as well as data presented at EuroPCR earlier this year, showing no increase in scaffold thrombosis between 12-month and 24-month follow-ups.4

    “This full cohort data of a broad patient population including more challenging indications such as NSTEMI, demonstrate that the Magmaris RMS is a safe and effective therapy option,” commented Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. “These results confirm that our unique resorbable magnesium technology does not share the same concerns as PLLA scaffolds, and does and will continue to play a significant role in vascular therapy. We believe in absorbable magnesium technology and patient care and see growing adoption within the medical community.“

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    * Superiority compared to Absorb BVS is shown with p=0.015 (one sided exact binomial tests α = 0.025)

     

    References:

    1 Probable or definite scaffold thrombosis 0.88% [97.5% CI:0;1.43]. BIOSOLVE-IV is powered for superiority to Absorb, with 2.066 patients. Based on the hypothesis of a definite and probable scaffold thrombosis value, inferior to 1.49%: a weighted distribution for definite and probable scaffold thrombosis rates of 1.49%, from selected Absorb BVS trials (ABSORB Cohort B1 and B2 (pooled) https://doi.org/10.1016/j.jcin.2012.02.017, ABSORB- II NCT01425281, ABSORB III NCT01751906, ABSORB EXTENDED NCT01023789, GHOST EU https://doi.org/10.1016/j.jcin.2015.10.042, ISAR-ABSORB DOI: 10.4244/EIJY14M07_11, BVS RAI NCT02298413.) Using a one-sided exact binominal test, superiority set to be achieved for α= 0.25. Magmaris definite and probable scaffold thrombosis in BIOSOLVE-IV is 0.88% [97.5% CI: 0;1.43], (corresponding Kaplan-Meier estimate is 0.8%).

    2 Target lesion failure is defined as composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization and emergent coronary artery bypass crafting.

    3 Bennett J, TCT 117: Performance and Safety of the Resorbable Magnesium Scaffold, Magmaris in a Real World Setting – Primary and Secondary Endpoint Analysis of the Full Cohort (2066 subjects) of the BIOSOLVE-IV Registry. Poster presented at TCT, November 6th, 2021.

    5CE approved. Indication as per IFU.

    6 Wiebe J, Nef HM, Hamm CW. Current Status of bioresorbable scaffolds in the treatment of coronary artery disease. Journal of American College of Cardiology. 2014, 64(23). DOI: 10.1016/j.jacc.2014.09.041.

    7 Wijns W. Why do we need scaffolds? Presented at: EuroPCR; May 22, 2018; Paris, France.

     

     

    Magmaris is a trademark or registered trademark of the BIOTRONIK Group of Companies.

    Absorb is a trademark or registered trademark of the Abbott Group of Companies.

    The Magmaris Resorbable Magnesium Scaffold is not currently commercially available in the United States.

    About Magmaris:

    Magmaris is the first resorbable magnesium scaffold (RMS) approved to treat de novo coronary artery lesions by percutaneous coronary angioplasty.6 Unlike stents, resorbable scaffolds support the vessel during a defined period and are thereafter resorbed by the body. The vessel is left uncaged and has the potential to overcome some of the issues associated with drug-eluting stents.5 Restoration of physiological vasomotion (blood vessels’ capacity to change in diameter), functional endothelial coverage, and the absence of residual foreign material in the vessel can potentially reduce the risk of stent thrombosis.7

    About BIOTRONIK:

    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.

    Source:

    Read original article here: https://news.biotronik.com/superiority-of-biotroniks-magmaris-resorbable-magnesium-scaffold-rms-in-scaffold-thrombosis-shown-versus-abbotts-absorb-bioresorbable-vascular-scaffold-in-largest-patient-cohort-to-date/

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