Teramed Targets Contraindicated Patients For AAA Stent Graft Market Entry
This article was originally published in The Gray Sheet
Teramed's kick-off of clinical studies for the Ariba and Tributary abdominal aortic aneurysm stent graft systems indicates both the rapid pace of differentiating innovation in the AAA market and industry's continued interest in minimally invasive surgical solutions to vascular disease.
You may also be interested in...
Guidant has begun shipping its Ancure endovascular graft for treatment of abdominal aortic aneurysm, and Medtronic is expected to launch its AneuRx AAA device shortly once the company's surgeon training program is finalized. FDA simultaneously approved the two devices on Sept. 28.
Guidance discusses what are generically called virtual inspections, but which the agency terms “remote interactive evaluations.” As site inspections remain constrained by the pandemic, remote interactive evaluations “should help FDA operate within normal timeframes,” the document says.
At Repro-Med, James Beck has been replaced by Linda Tharby as CEO, and more.