title: Second-generation magnesium scaffold Magmaris: device design and preclinical evaluation in a porcine coronary artery model.
abstract: OBJECTIVE
  The second-generation drug-eluting absorbable magnesium scaffold Magmaris, recently introduced for the treatment of obstructive coronary atherosclerotic lesions, suggests a good safety profile, but preclinical assessment is important for predicting clinical performance. The aim of the present study was to assess subacute and long-term safety as well as pharmacokinetic properties of the Magmaris compared with a current-generation metallic DES and an approved BRS in porcine and rabbit animal models.
  
  
  RESULTS
  Ninety Magmaris scaffolds were implanted into non-diseased porcine and rabbit models. A bioresorbable vascular scaffold (Absorb) and a permanent drug-eluting stent (XIENCE Xpedition) served as controls. Scanning electron microscopy showed increased endothelialisation and decreased thrombus formation at three and 28 days in the Magmaris group compared with the Absorb group. In the XIENCE group, inflammation exceeded the level in the Magmaris group at 365 and 730 days. Neointimal growth was greater in the Magmaris group than in the XIENCE group. Late lumen loss decreased over time in both groups. Optical coherence tomography (OCT) showed stable luminal dimensions in both the Magmaris and XIENCE groups. Pharmacokinetic studies demonstrated a retarded elution profile in the Magmaris group with 69.4% of sirolimus released at 90 days.
  
  
  CONCLUSIONS
  Preclinical results suggest that the Magmaris has a favourable safety profile with advanced healing relative to benchmark, low acute thrombogenicity, and absence of excessive lumen loss up to two years. These results support clinical application of Magmaris for human use.
authors.affiliation: MedStar Washington Hospital Center, Washington, DC, USA.
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: Philine
authors.initials: P
authors.lastname: Zumstein
authors.forename: Martin
authors.initials: M
authors.lastname: Pritsch
authors.forename: Eric
authors.initials: E
authors.lastname: Wittchow
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.forename: Capucine
authors.initials: C
authors.lastname: Lapointe-Corriveau
authors.forename: Guy
authors.initials: G
authors.lastname: Leclerc
authors.forename: Michael
authors.initials: M
authors.lastname: Joner
mesh_terms: D020341:Absorbable Implants; D000818:Animals; D002317:Cardiovascular Agents / Q000627:therapeutic use; D023921:Coronary Stenosis / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology / Q000601:surgery; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000627:therapeutic use; D008274:Magnesium; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011474:Prosthesis Design; D011817:Rabbits; D020123:Sirolimus / Q000627:therapeutic use*; D013552:Swine; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; D008274:Magnesium; D020123:Sirolimus