Lombard Medical Technologies PLC, is confident it will jump the final hurdles as it gains written feedback from the U.S. FDA on the PMA application for Aorfix™, the Company’s flexible stent graft for the endovascular repair of abdominal aortic aneurysms.
Bolton Medical has announced the FDA’s approval of its Relay® Thoracic Stent-Graft with Plus Delivery System. The device is designed to address the needs of physicians performing minimally invasive surgery for thoracic aortic aneurysms and penetrating ulcers.
University of Pittsburgh’s cell-free, biodegradable artery graft results in a regenerated artery in 90 days, leaving behind no trace of synthetic graft materials in the body.
US Regulatory Agency, the FDA has selected Medtronic’s thoracic stent graft development product for inclusion in its early feasibility pilot program.
Medtronic, Inc. has synchronised the U.S. launch of the recently FDA cleared Endurant® II AAA Stent Graft System with the Society for Vascular Surgery’s Vascular Annual Meeting being held right now. The company claims its new iteration enhances access and ease of use compared with the first generation product.
More from CX34 as Medtronic’s Endurant AAA Stent Graft 2 year data gets a positive airing.
Cook Medical has initiated enrollment in a U.S. clinical trial of its high-precision, next-generation Zenith® Low Profile AAA Endovascular Graft (Zenith AAA LP).