Medtronic AAA stent grafts
This article was originally published in The Gray Sheet
Xcelerant delivery system earns CE mark for use with Talent abdominal aortic aneurysm stent graft. The system features improved catheter material and an integrated deployment handle to enhance trackability, aid kink resistance and decrease deployment force, resulting in reduced implant procedure times, Medtronic says. The company also launches "higher density" Resilient graft material for its U.S. AAA stent graft, the AneuRx. The material aims to "reduce porosity and improve durability," the firm explains July 14. Medtronic's AAA announcements follow controversy over an FDA-authored article about AneuRx safety data that was retracted from a peer-review journal after Medtronic threatened litigation over use of proprietary clinical data (1"The Gray Sheet" July 12, 2004, p. 29)...
You may also be interested in...
AdvaMed's intent to craft a position on the release of proprietary data generated by manufacturers during clinical trials should gain momentum from recently publicized study data on Medtronic's AneuRx device
Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.
However, Vaccinex sees possible efficacy for SEMA4D inhibition in later-stage Huntington’s as well as Alzheimer’s disease. Pepinemab is also being studied with Keytruda in head-and-neck cancer.