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 [...]

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: , , , |

Merit Medical launches Torpedo gelatin foam for embolisation of hypervascular tumours

Torpedo Merit Medical has launched Torpedo—a proprietary gelatin foam indicated for use in the embolisation of hypervascular tumours—onto the market. According to a press release, the Torpedo provides physicians with a pre-shaped gelatin foam loaded into a cartridge with an optional blunt stylet, removing the need for manual foam shaping and providing [...]

2019-09-17T16:19:06+00:00September 17th, 2019|Tags: , |