Medtronic Valiant Captivia demonstrates safety and efficacy at three years

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Medtronic has announced new data, demonstrating safety and efficacy at three years in acute complicated type B aortic dissection patients treated with the Valiant Captivia thoracic stent graft system. Ali Azizzadeh, University of Texas Health Science Center, USA, presented the new clinical data in a late-breaking trial session at Vascular Interventional Advances 2016 (VIVA; 18-22 September, Las Vegas, USA).

“Evidence shows that patients with acute complicated type B aortic dissections can be safely and effectively treated with thoracic endovascular aortic repair (TEVAR),” said Azizzadeh. “The Valiant Captivia system continues to produce positive outcomes through three years in a very challenging patient population.”

The data were gathered on 50 patients in the Medtronic Valiant Captivia dissection IDE trial, conducted at 16 US sites. Data highlights through three-year follow-up include:

  • Freedom from all-cause mortality of 79.4%
  • Freedom from dissection-related mortality of 90%
  • No post-index procedure ruptures or conversions
  • True-lumen diameter over the stented region remained stable or increased in 92.3, false-lumen diameter remained stable or decreased in 69.2%, and the false lumen was partially or completely thrombosed in 75% of patients
  • Three patients required secondary endovascular procedures related to the dissection.