Magmaris

Vaskuläre Intervention // Koronar
Resorbierbarer Magnesium-Scaffold (RMS)
 
Magmaris®
 
 


 
 
 
 
 
 
 
 

 
 
 
 
 
 

 

Magmaris

*Indikation gemäß Gebrauchsanweisung.
 
 
1-3, 11-14. BIOTRONIK Archivdaten. 4. Verheye S. Safety and performance of the resorbable magnesium scaffold, Magmaris in a real world setting - First 200 subjects at 12-month follow-up of the BIOSOLVE-IV registry. Presented at: EuroPCR; May 22, 2018; Paris, France. ClinicalTrials.gov: NCT028. 5. Haude M, Ince H, Kische S, et al. Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries at 12-month follow-upBIOSOLVE-II and BIOSOLVE-III. Journal of the American College of Cardiology. 2017; 70(18). DOI: 10.1016/j.jacc.2017.09.071. 6. Waksman R. Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries at 12-month follow-up- BIOSOLVE-II and BIOSOLVE-III. Presented at : TCT; Oct 31, 2017; Denver, USA. 7. Haude M, Ince H, Abizaid A. Long-term clinical data and multimodality imaging analysis of the BIOSOLVE-II study with the drug-eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries – BIOSOLVE-II. Presented at: EuroPCR; May 23, 2018; Paris. France. 8. Haude M, Erbel R, Erne P, et al. Safety and performance of the Drug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicenter, first-in-man BIOSOLVE-I trial. EuroIntervention. 2016; 12(2): e160-6. 9. Joner M, Ruppelt P, Zumstein P, et al. Preclinical Evaluation of Degradation Kinetics and Elemental Mapping of First and Second Generation Bioresorbable Magnesium Scaffolds. EuroIntervention. 2018 Feb 20. pii: EIJ-D-17-00708. doi: 10.4244/EIJ-D-17-00708. [Epub ahead of print]. 10. BIOSOLVE-II Fall, GER443012. Mit freundlicher Genehmigung von M. Haude, Lukaskrankenhaus Neuss, Deutschland 2015. *Indikation gemäß Gebrauchsanweisung.
 
Magmaris ist eine Marke oder eingetragene Marke der Unternehmensgruppe BIOTRONIK.

Technische Daten

Scaffold
Scaffold-Material Unternehmenseigene Magnesiumlegierung
Marker Zwei Tantal-Marker an jedem Ende
Aktive Beschichtung Bioresorbierbare BIOlute-Poly-L-Milchsäure (PLLA) mit Abgabe von Limus Medikament
Wirkstoffdosis 1.4 μg/mm2
Strebendicke/-breite 150 μm/150 μm
Max. expandierter Durchmesser Nominaldiameter +0.6 mm
Einführsystem
Kathetertyp Rapid exchange
Empfohlener Führungskatheter 6F (min. ID: 0.070")
Crossing-Profil 1.5 mm
Führungsdraht-Durchmesser 0,3556 mm (0,014")
Arbeitslänge des Katheters 140 cm
Ballonmaterial Semikristallines Polymer (SCP)
Beschichtung (distaler Schaft) Doppelt beschichtet
Markierungsbänder Zwei Platin-Iridium-Marker
Proximaler Schaftdurchmesser 2,0 F
Distaler Schaftdurchmesser 2,9 F
Nominaldruck (NP) 10 atm
Berstdruck (RBP) 16 atm

Compliance-Tabelle

Ballondurchmesser x Länge (mm)
Nenndruck atm8 10 10
(PN) ø (mm) 3,00 3,54
Berstdruck atm8 16 16
(RBP) ø (mm) 3,29 3,82

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