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: AltoTM Abdominal Stent Graft System
PMA Applicant: Endologix, Inc.
Address: 3910 Brickway Blvd., Santa Rosa, CA 95403
Approval Date: March 13, 2020
Approval Letter: Approval Order
What is it?
The Alto™ Abdominal Stent Graft System is intended to repair a weakened and bulging section (aneurysm) of the aorta (largest part of the abdomen) below the renal arteries (infrarenal abdominal aorta). The system consists of the following components:
- Implant: Plastic tubes with sealed polymer-filled plastic outer rings with an upper bare metal framework (stent) made of nickel-titanium alloy (nitinol)
- Extension Implants: Plastic tubes supported by internal stents made of nitinol
- Delivery Catheter: A long thin tube used to place the implants
This supplement includes changes made to the implant and delivery system design for the Ovation Abdominal Stent Graft System.
How does it work?
The delivery catheter containing the stent graft is inserted into the blood vessel in the upper leg (femoral artery) through a small cut. The stent is carefully guided within the abdominal aorta to the site of the aneurysm. The stent graft is then released (deployed) and expands to the width of the aorta. The stent graft provides a path for the blood to flow, which can prevent further aneurysm growth and possible bursting (rupture) of the aorta.
When is it used?
The Alto™ Abdominal Stent Graft System is used to treat patients with aneurysms of the infrarenal abdominal aorta.
What will it accomplish?
The Alto™ Abdominal Stent Graft System prevents further growth and rupture of the aneurysm. If the device does not completely seal off the aneurysm from blood flow, additional procedures may be needed to prevent aneurysm growth and rupture.
In a clinical study of patients treated with the Alto™ Abdominal Stent Graft, 95% of patients (or 58 of 61 patients) did not have device- or aneurysm-related issues at one year after the procedure.
When should it not be used?
The Alto™ Abdominal Stent Graft System should not be used in patients who have:
- A condition that threatens to infect the graft.
- Known sensitivities or allergies to the device materials.