42 results

• Endologix AFX2 Graft Risk Information Updated in FDA-Approved Labeling

  December 8, 2022

  Russell Maas

  The FDA is requiring new label warnings and post-marketing studies on the Endologix AFX2 graft system, which has been linked to potentially life-threatening endoleaks.

• Women Have Lower Survival Rates Following Aortic Aneurysm Repair Surgery: Study

  May 31, 2022

  Martha Garcia

  A new study finds that women suffer worse outcomes and survival rates than men following aortic aneurysm repair surgery.

• Patients Who Underwent Abdominal Aortic Aneurysm Repair Require Lifelong Surveillance, FDA Warns

  March 1, 2022

  Martha Garcia

  Following the advice of a panel of scientific advisors, the FDA is now calling on health care professionals to conduct lifelong surveillance of patients who have undergone abdominal aortic aneurysm repair surgery.

• Endologix AFX Graft System Should Not Be Used For Abdominal Aortic Aneurysms Due To Endoleaks: FDA

  January 17, 2022

  Russell Maas

  The FDA is warning of potentially deadly endoleaks linked to endovascular graft systems, and call for patients with such systems to be closely monitored.

• Medtronic Valiant Navion Thoracic Stent Graft System Recall Issued Due To Endoleaks and Fractures

  April 12, 2021

  Russell Maas

  The FDA has announced a Medtronic stent graft system recall after reports of malfunctions, serious injuries, and at least one death.

• Elective Thoracic Aortic Aneurysm Repair Surgery Greatly Reduces Risk of Death: Study

  March 8, 2021

  Martha Garcia

  A new study shows patients who address aortic aneurysms through elective surgery have a greater chance of survival than those who have to undergo aortic repair surgery due to an emergency.

• Levaquin, Avelox, Similar Antibiotics May Increase Risk Of Aortic Aneurysms: Study

  January 11, 2021

  Irvin Jackson

  A new study adds to concerns antibiotics like Avelox, Cipro and Levaquin can cause aortic aneurysms which put patients' lives at risk.

• Patients With AFX Endovascular Grafts Should Get Annual Checkups For Endoleaks: FDA

  December 7, 2020

  Russell Maas

  The FDA warns patients who received Endologix AFX Endovascular graft systems follow up with their doctor annually due to the risk of endoleaks which could cause health complications.

• Antibiotics Risk of Aortic Aneurysm, Aortic Dissection Questioned in New Study

  September 14, 2020

  Irvin Jackson

  A new study questions whether there is need for concern about aortic dissection and aortic aneurysm risks linked to Levaquin, Cipro and Avelox.

• Ovation iX Abdominal Stent Graft Recall Issued Over Polymer Leaks

  June 17, 2020

  Russell Maas

  The FDA warns that a recalled stent graph could leak polymer into patients' bodies, posing a risk of severe injury and death.