New aortic and peripheral data from two late-breaking trials revealed by Medtronic


New clinical data in interventional treatments for aortic and peripheral vascular diseases have been revealed by Medtronic during a late-breaking trial session at Vascular Interventional Advances (VIVA) 2015.

Data for the Valiant Captivia thoracic stent graft system for the treatment of complicated type B aortic dissection have shown positive two-year clinical results. The data were presented by Ali Azizzadeh, University of Texas Health Science Center, Texas, USA.

The FDA-approved Valiant Captivia system has been shown to demonstrate continued safety and efficacy at two years. The data were gathered on 35 patients in the Medtronic Valiant Captivia Dissection IDE trial, conducted at 16 USsites. The one year outcomes in the trial were recently published in the Annals of Thoracic Surgery.

Highlights of the data:

  • No post-index procedure ruptures or conversions through two years follow-up.
  • No new device related adverse events reported between the one and two year follow-ups.
  • No loss of stent graft integrity or stent graft collapse through two years follow-up.
  • At two years follow-up, true-lumen diameter over the stented region remained stable or increased in 85.7%, false-lumen diameter remained stable or decreased in 78.6%, and the false lumen was partially or completely thrombosed in 70.4% of patients.

“There is a growing body of evidence supporting the use of thoracic endovascular aortic repair (TEVAR) as a safe and effective treatment for patients with acute type B aortic dissections,” says Azizzadeh. “The Valiant Captivia System has continued to produce positive patient outcomes at two years.”

John Rundback, Holy Name Medical Center, New Jersey, USA, presented nine-month data from unique companion studies for patients with a diverse range of symptomatic iliac atherosclerotic disease. The presentation compared data from three Medtronic stents for the treatment of PAD in the DURABILITY Iliac and VISIBILITY Iliac study. The Protégé EverFlex self-expanding stent system, the Protégé GPS self-expanding nitinol stent and delivery technology and the Visi-Pro balloon expandable stent system.

In this comparison, the nine-month major adverse event rate was 1.3% for SES and 4% for BES, patency rates were similar between the two groups, both at 95.8%. These data demonstrate safety and effectiveness and comparative utilisation patterns for balloon expandable stents and self-expanding stents in the treatment of iliac artery atherosclerosis.