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 [...]
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 [...]
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 [...]