Wrapsody – BIBA Medtech Insights

FDA approval of IN.PACT AV is a boon for management of dysfunctional AVFs

Andrew Holden Recently, the FDA approved Medtronic’s paclitaxel-coated balloon IN.PACT AV for the management of failing arteriovenous fistulae (AVF). Approval for the device was based on data from the IN.PACT AV Access trial, which showed the device to significantly increase primary patency compared with standard percutaneous transluminal angioplasty. Andrew Holden (Department of [...]

2019-12-11T09:58:01+00:00December 6th, 2019|Tags: Approvals & refusals, AVF, Concept Medical, IN.PACT AV, MagicTouch AVF, Medtronic, Merit Medical, Wrapsody|

FDA Breakthrough Device Designation for Wrapsody endovascular stent graft system

Wrapsody Merit Medical has been granted Breakthrough Device Designation by the FDA for the Wrapsody endovascular stent graft system. A press release reports that the Wrapsody system is a flexible, self-expanding endoprosthesis for which Merit intends to seek indication for use in haemodialysis patients for the treatment of stenosis within the central veins [...]

2019-11-25T13:27:35+00:00November 25th, 2019|Tags: Approvals & refusals, Merit, Merit Medical, Wrapsody|