First patient enrolled globally in SELUTION SLR study for AV fistulae

Selution SLR MedAlliance has announced enrolment of the first patient in the SAVE (Use of the Selution sirolimus-eluting balloon for dysfunctional AV access treatment indications) study utilising their novel sirolimus-eluting balloon, for the treatment of failed arteriovenous (AV) fistulae in renal dialysis patients. The objectives of this prospective, randomised, single-blind multicentre study [...]

2020-04-16T13:42:19+00:00April 16th, 2020|Tags: , , |

Selution SLR receives CE mark for endovascular applications

MedAlliance has announced that it now has the CE mark for the Selution SLR—a sirolimus drug-eluting balloon for the treatment of peripheral arterial disease. This approval applies to sizes from 2x20mm to 7x150mm. According to a press release, this award was supported by two-year results from the SELUTION SLR first-in-human study, which involved 50 [...]

2020-02-05T12:54:47+00:00February 5th, 2020|Tags: , , |

FDA Breakthrough Device Designation for Selution SLR in arteriovenous fistulae

MedAlliance has now been granted FDA Breakthrough Device Designation status for its Selution sustained limus release (SLR) sirolimus-eluting balloon for an arteriovenous fistulae indication. The company has previously received similar status for the coronary in-stent restenosis and peripheral below-the-knee indications of the balloon. According to a press release, Selution’s technology involves unique micro-reservoirs made [...]

2020-01-15T15:36:52+00:00January 15th, 2020|Tags: , , |

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). [...]

MedAlliance receives FDA Breakthrough Device Designation for its sirolimus-eluting balloon for below-the-knee lesions

MedAlliance has been awarded FDA Breakthrough Device Designation for the Selution SLR, which is a sustained limus release drug-eluting balloon catheter for the treatment of below-the-knee disease. According to a press release, the company was the first drug-eluting balloon company in the world to receive FDA Breakthrough Device Designation status for the treatment of [...]

2019-10-01T14:53:22+00:00September 26th, 2019|Tags: , , , |