Qmedics achieved to close with success the first investigator meeting
“Horizon” Clinical investigation of the Qmedics Exist & Falcor NiTi Stent portfolio with the Flex & Pull type in adults with Peripheral Artery Disease (PAD).
“Horizon” Clinical investigation of the Qmedics Exist NiTi Stent portfolio with the Flex & Pull type in adults with Peripheral Artery Disease (PAD).
Qmedics has started with the preparation of a prospective, non-randomized, multi-centre, multi-national, monitored trial, “HORIZON” will be conducted at several investigational sites in Europe. The HORIZON trial data will support safety and effective clinical performance of the Medics Exist NiTi stent type Flex & Pull.
The investigational products Exist (6Fr) has two types they posses the Flex and Pull properties. This novel design is for treating the lesion characteristics as well as taking in consideration the movability of the arteries.
Flex: The Flex property is recommended to be used in complex and moderate calcified lesions with arteries subjected to bending deformation in combination with radial compression.
Pull: The Pull property is recommended to be used in highly calcified and difficult to cross lesions with arteries subjected to longitudinal deformation and radial compression.
Primary endpoint: Freedom of procedure- or stent-related Major Adverse Events (MAEs) at 30 days and 12-months post-index procedure rate of TLR, PP and MAEs at 6 and 12 months. Secondary endpoint: procedural success, ankle- brachial index (ABI) pre- and several FU periods, patency of treated vessel at FU (loss of patency defined as target vessel revascularization (TVR), or ≥ 50% stenosis & QOL questionnaire Clinical follow up to 3 years.
Qmedics wants to become an innovator in the field of arterial peripheral interventions that aims to improve clinical outcomes and quality of life. A major milestone was reached in the development of its novel designed stent technology. A vascular stent portfolio specifically designed to provide superb vessel scaffolding, enhancing accurate stent deployment regardless of the movability of the artery and in compliance of the lesion characteristics by using two different types of stents: PULL & FLEX.
Qmedics hopes to be ready with the preparations and start the trial early 2020.