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 [...]

First sirolimus device for peripheral arterial disease enters European market

MagicTouch AVF Concept Medical has received the CE mark for its MagicTouch sirolimus-coated percutaneous transluminal angioplasty (PTA) catheter, making the catheter the first commercially available sirolimus device for peripheral arterial disease. The MagicTouch catheter has also been approved for treating erectile dysfunction (MagicTouch ED) and for managing arteriovenous fistula complications (MagicTouch AVF). [...]

MagicTouch becomes first sirolimus-coated balloon for peripheral arteries to receive the CE mark

MagicTouch AVF Concept Medical BV has received the CE mark for its range of MagicTouch drug-coated balloons. The balloons are indicated for peripheral arterial disease, erectile dysfunction, arteriovenous fistula and arteriovenous graft. The CE mark approvals mean that the MagicTouch percutaneous transluminal angioplasty (PTA) catheter is the only commercially available, CE-mark certified, [...]

2019-10-24T14:15:39+00:00October 24th, 2019|Tags: , , |

FDA Breakthrough Device Designation for MagicTouch AVF sirolimus-coated balloon

MagicTouch AVF Concept Medical has been granted Breakthrough Device Designation from the FDA for the MagicTouch AVF, sirolimus-coated, balloon catheter for the management of stenotic lesions of arteriovenous fistulae or arteriovenous graft in haemodialysis treatment of renal failure. The proposed indications for the MagicTouch AVF devices are for it to be used, [...]

2019-09-01T06:59:37+00:00September 1st, 2019|Tags: , , |

FDA Breakthrough Device Designation for sirolimus-coated MagicTouch peripheral balloon

Concept Medical has been granted Breakthrough Device Designation from the FDA for its MagicTouch percutaneous transluminal angioplasty (PTA) device—a sirolimus drug-coated balloon catheter—for the treatment of below-the-knee lesions. Earlier this year, on 30 April 2019, Concept Medical received its first Breakthrough Device for its MagicTouch coronary balloon for the treatment of Coronary Artery Disease [...]

2019-08-21T15:25:34+00:00August 14th, 2019|Tags: , , |