Endovascular Today

Shape Memory Medical’s Pivotal AAA SHAPE Trial Completes Enrollment

Shape Memory Medical Inc., developer of a commercially available volume-expanding shape memory polymer for endovascular embolizatio ...
TCTMD

SAFE-AAA Flags Ongoing EVAR Device Risk and Urges More Surveillance

An endovascular stent graft for abdominal aortic aneurysm (AAA) that has had a troubled safety history does not meet noninferiority compared with other commercially available options, according to the ...
TCTMD

EVAR—but Not Surgical AAA Repair—Is Riskier Long-term for Women

That women fare worse than men after treatment for abdominal aortic aneurysm isn’t news, but 10 years’ worth of US registry data show that the difference is long-lasting and appears restricted to ...
Endovascular Today

FDA Approves Updated Labeling of Gore Excluder EVAR Devices for Ruptured AAAs

Gore & Associates announced that the FDA approved updated labeling for the Gore Excluder abdominal aortic aneurysm (AAA) ...
Medscape

FDA Urges Lifelong Follow-Up After Endovascular Aortic Repair

Patients who have undergone endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) need lifelong surveillance, including imaging, the US Food and Drug Administration (FDA) advises.
Business Wire

Shape Memory Medical Receives FDA IDE Approval to Initiate AAA-SHAPE, a Head-to-Head Trial

SANTA CLARA, Calif.--(BUSINESS WIRE)--Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced that the Food and Drug Administration (FDA) granted ...
MD&M East

Can a New FDA Labeling Approval Give Medtronic an Edge in EVAR?

FDA has approved new labeling for Medtronic’s Endurant stent graft system. The Dublin-based company said the labeling approval adds ruptured abdominal aortic aneurysm (rAAA) clinical evidence and ...

Shape Memory Medical Completes Enrollment in Landmark AAA‑SHAPE Randomized Controlled Pivotal Trial

Shape Memory Medical Inc., developer of the only commercially available volume‑expanding shape memory polymer for endovascular embolization, announced today that it has completed enrollment in the AAA ...