A new FDA approved stent for congenital heart disease: First-in-man experiences with G-ARMORTM

Catheter Cardiovasc Interv. 2022 Dec;100(7):1261-1266. doi: 10.1002/ccd.30447. Epub 2022 Nov 2.


We present the first clinical experience with a new hybrid cell structure covered stent, designed for congenital heart disease applications. It represents a significant redesign of the Cheatham Platinum (CP) Stent (Numed Inc.), maintaining the traditional benefits of the covered CP whilst significantly decreasing shortening and allowing controlled flaring at the ends through its combination of larger and standard sized cells. We first implanted the stent in 2 patients with superior sinus venosus defects with anomalous drainage of the right upper and middle lobe pulmonary veins. The first was a 40 year male and the second a 36 year old female. The third case was a 60 year old patient with near atresia of the aorta, with pre and poststenotic aortic dilation. The clinical result in all cases was excellent with no obstruction to pulmonary venous return and no visible L-R shunt on the transthoracic echo on 24 h and 2 week follow-up for the patient with sinus venosus defects and uniform complete revascularization of the aorta without any vascular complications in the patient with coarctation. These are the first uses of this stent in human subjects. The design is specifically aimed toward procedures where stent shortening is undesirable. Hence, coarctation of the aorta as well as stent implantation in preparation for percutaneous pulmonary valve placement are obvious use areas, as well as the growing body of evidence supporting percutaneous treatment of sinus venosus defects.

Keywords: aortic coarctation; conduit stenting; covered stent; large vessel stent; percutaneous pulmonary valve placement; sinus venosus atrial septal defects.

Publication types

  • Case Reports

MeSH terms

  • Adult
  • Aortic Coarctation* / therapy
  • Female
  • Heart Defects, Congenital* / diagnostic imaging
  • Heart Defects, Congenital* / therapy
  • Heart Septal Defects, Atrial*
  • Humans
  • Male
  • Middle Aged
  • Platinum
  • Stents
  • Treatment Outcome


  • Platinum

Supplementary concepts

  • Atrial Septal Defect Sinus Venosus