This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Endurant II/Endurant IIs Stent Graft System (Prosthetic endovascular graft)
PMA Applicant: Medtronic Vascular
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: September 29, 2017
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100021S063a.pdf
What is it? The Endurant II/Endurant IIs Stent Graft System (also referred to as Endurant II/IIs Stent Graft System) is a flexible fabric tube supported by a metal framework (stent graft), which is used to repair a weakened and bulging section (aneurysm) of the abdominal aorta (largest artery in the abdomen). The stent graft is placed using a long, thin, tube-like device (delivery catheter). In some patients with challenging anatomy, the Heli-FX EndoAnchor System can be used with the Endurant II/IIs Stent Graft System to help hold the stent graft in place. The Heli-FX EndoAnchor System places small wire coils through the top part of the stent graft into the artery wall to keep the stent graft from moving.
How does it work? The Endurant II/IIs delivery catheter containing the stent graft is first inserted into an artery in the upper leg (groin) through a small incision. It is then carefully guided to the site of the aneurysm in the aorta and released, so that the stent graft relines the weakened and bulging section of the wall of the aorta. This relieves the pressure that the blood flow was putting on the aneurysm to prevent it from bursting and causing death. Once the Endurant II/IIs stent graft is in place, the Heli-FX EndoAnchor implants are placed in the top part of the stent graft to hold it to the aortic wall to keep the stent graft from moving.
When is it used? The Endurant II/IIs Stent Graft System is used in patients who have an abdominal aortic aneurysm (AAA). The Heli-FX EndoAnchor System is used with the Endurant II/IIs Stent Graft System when it is needed to help keep the stent graft in place.
What will it accomplish? The use of the Endurant II/IIs Stent Graft System in combination with the Heli-FX EndoAnchor System may prevent further growth or rupture of the aneurysm. Data supporting the approval to use these devices together included results of a study with 70 participants with AAAs and challenging anatomies. The study included 30-day and 1-year data, and follow up data will continue to be reported out to 5 years. The results were compared to available data sources from commonly used treatment methods for these anatomies to put the results in context. This clinical data showed that these devices are safe and effective for use in patients with AAA who have challenging anatomies and that cannot be treated with other marketed devices. Clinical evidence showed that the use of the Endurant II/IIs Stent Graft System in combination with the Heli-FX EndoAnchor System was effective in anchoring the graft in the intended location without additional risks.
When should it not be used? The Endurant II/IIs Stent Graft System with the Heli-FX EndoAnchor System should not be used in patients who have a condition that threatens to infect the graft or in patients with sensitivities or allergies to the device materials.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.