News | QMedics

31. July 2019

NEW PRODUCT added to our Portfolio

Our investors made it possible to expand our product portfolio with “Easyx“ a liquid Embolic that provides another treatment option for peripheral physicians - the start in Qmedics embolization portfolio, Qmedics embolization pipeline: occlusion balloon and an embolization plug

The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO).
EASYX™ is CE-marked since December 2016 for the use in peripheral vasculature. The safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML) was proven in a clinical trial EASYX-1.

EASYX-1: A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications. Publication is planned very soon.

Second clinical trial for the extention of the EASYX indications:

Prospective, Multicenter, Multinational Study to Assess the Safety and Performance of the Easyx Liquid Embolic in Intracranial Interventions IDEALE Study.
This is a Prospective Study to Assess the Safety and Performance of the Easyx Liquid Embolic in Intracranial Interventions.

31. May 2019

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).

Qmedics has started a trial “HORIZON” A prospective, non-randomized, multi-center, multi-national, Monitored trial, conducted at several investigational sites in Europe. The HORIZON trial data will support safety and effective clinical performance of the Medics Exist and Falcor NiTi stent type Flex & Pull. Simultaneous Qmedics designed with the stent portfolio family a PTA Balloon family so that all lengths and diameters of the families are coordinated. The Exist is married with the Manatee BDC and the Falcor with the Nage BDC.

The investigational products Exist (6Fr) and Falcor (5Fr) have DE NOVO technology as they posses the Flex and Pull properties. Each one of them has identical technical properties over their entire lengths and diameter what is unique in the stent design world. This novel design is for treating each characteristic lesion in consideration with the specific 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 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 within each lesion characteristics by using two different types of stents: PULL & FLEX.

28. February 2019

Qmedics reached the next milestone

“We expanded our peripheral product portfolio with the “FALCOR” as the 5 Fr introducer compatible stent with the two types "Pull & Flex”.

Parallel with this milestone Qmedics opened a PMS post market surveillance: Qmedics started the PMS “REVEAL”

The post-marketing surveillance is a regulatory necessity and provides continuous feedback about our stent portfolio on the market in order to maintain a high standard of product quality. It gives us at all times the data how the product performs. This data and the clinical professionals experience can help to improve our stent portfolio if needed.

The REVEAL is gathering data: pre-during the intervention, voluntary over the following 12 months and at 12 months a mandatory FU. Further the PMS will follow these implants over their entire lifetime on the quality, performance and safety by gathering feedbacks of the clinical professionals and patients them selfs. Qmedics want to be on the forefront of innovative technology and deliver these state- of- the- art products to imporve patient care.

Cathlab here we come!!!!!
Qmedics will be a friend of gathering as much as possible information on the stent portfolio and on the wellbeing of our patients. First results of the Reveal PMS is planned to be presented at Linc 2020.

We also will give an update in our website.