Thoraflex Hybrid is designed for the open surgical repair of aneurysms and/or dissections in the aortic arch and descending aorta with or without involvement of the ascending aorta. There are two types of Thoraflex Hybrid implants, namely the Plexus 4 and the Ante-Flo versions. Each patient receives one Thoraflex Hybrid device (either the Plexus 4 or Ante-Flo).

The RelayPro NBS Thoracic Stent-Graft System is an endovascular device intended for treatment of thoracic aortic pathologies such as aneurysms, pseudoaneurysms, dissections, penetrating ulcers and intramural hematoma.

• Permanent disabling stroke (mRS >2 and an increase in at least one mRS category from the individual's pre-stroke baseline, occurring within 30 days of either index procedure or extension and present at 1-year follow-up)* Note: If a subject dies prior to 1-year follow-up, their last recorded mRS will be considered their final score
• Grade 3 spinal cord ischemia (SVS reporting standards) occurring within 30 days of either index procedure or extension
• All-cause mortality (within 1 year of either procedure)

(*Per VARC-3, disability assessment using the mRS should be performed between 30 and 90 days after a neurological event with 90 days being optimal. An increased mRS score by itself and in the absence of a neurological event does not constitute stroke.)

Defined as device technical success (of either procedure) with absence of the following at 1-year:

• Lesion-related mortality (defined as all deaths occurring within 30 days of, or, prior to discharge, from either the index procedure or the extension procedure or any revision procedures to treat the original lesion(s) and any other deaths adjudicated by Clinical Events Committee as related or probably related to the lesion(s))

• Aortic rupture in the treated segment

• Lesion expansion (≥5mm increase from measurement at discharge/within 30 days)

• Secondary intervention to address the following:

  • Stent graft-induced aortic wall injury (SAWI)
  • Fistula
  • Type I or III endoleak (see definitions)
  • Migration
  • Loss of Patency
  • Thromboembolic events
  • Failure of integrity

• All-cause mortality, and
• Lesion-related mortality (defined as all deaths occurring within 30 days of, or, prior to discharge, from either the index procedure or the extension procedure or any revision procedures to treat the original lesion(s) and any other deaths adjudicated by Clinical Events Committee as related or probably related to the lesion(s))
• All/any paraplegia/paraparesis defined as SCI (SVS grades 1 to 3)
• Any stroke (excluding TIA)
• Incidence of Myocardial Infarction
• Incidence of Respiratory Failure
• Incidence of Renal Failure
• Incidence of Bowel Ischemia