28. February 2022

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

Specific focus on the SFA and P1 – with the EXIST self-expandable “PULL” and FLEX” Stent System types. (See the full case film in the clinical studies Rubric)

The Horizon study will provide information on the long-term outcomes of the innovative EXIST NiTi self- expandable stent with its two types of PULL & FLEX, designed to be used in combination with the new Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter MANATEE. The EXIST NiTi stent is specifically tailored for, but not only limited to the treatment of the femoropopliteal region taking into account the patient’s anatomy and lesion characteristics.

Self-expandable nitinol stenting can accomplish revascularization of severely diseased peripheral arteries with good clinical success and freedom from complications. However, longer-term patency rates in the femoro-popliteal region remain a concern, especially due to the extrinsic forces of flexion and torsion acting on these arteries with the movements of the lower limbs. At this level, heavy calcifications and lesions that are present in the distal Superficial Femoral Artery (SFA) and the P1 tract of the Popliteal Artery represent the main technical challenges and require stents with dedicated structural characteristics. The aim of the Horizon study is to test, in the femoro-popliteal,region  the two types of EXIST NiTi Stent (FLEX and PULL), whose design is meant to comply with the movability of the SFA and P1, while adapting to the specific characteristics of difficult atherosclerotic plaques.

The HORIZON trial is a prospective, non-randomized, multi-centre, multi-national, open-label, post-market clinical trial conducted in several investigational sites in Europe. The target population is subjects with a documented diagnosis of Peripheral Artery Disease (PAD) requiring Percutaneous Transluminal Angioplasty (PTA) treatment and stent placement at the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (P1 segment). Subjects, who meet all inclusion and none of the exclusion criteria will be treated with the Qmedics EXIST NiTi Stent type FLEX and/or PULL. Subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Qmedics EXIST NiTi stent type FLEX. Subjects  requiring  treatment  of  the  SFA  will  undergo  an  additional  calcification  review  based  on  the Fanelli  classification. Subjects graded with Fanelli 1 or 2 will be treated with the Qmedics EXIST NiTi Stent FLEX. Fanelli grade 3 and 4 subjects will be treated with the Qmedics EXIST NiTi Stent PULL. There will be 230 subjects enrolled in HORIZON and the trial will be conducted in several investigational centres in Europe.

This new generation of Qmedics NiTi stent family is a self-expanding nitinol stent system made in 3 variants (4, 5 and 6F NiTi Stent System), two types – PULL and FLEX – and with stent lengths in both types ranging up to 200mm. The portfolio was launched in the EU and other CE mark-accepting countries in the very difficult year of 2020, where COVID was playing an inhibitory role but Qmedics did succeed, nonetheless. Now with the help of the professionals, we will gather the clinical evidence on this innovative concept.

The first patient was enrolled by investigator Prof. Dr. Hab. n. med. Jerzy Głowiński and Dr.M Chlabicz Vascular Surgeons at University Clinical Hospital of Bialystok, Poland.

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

Prof. Dr. Hab. n. med. Jerzy Głowiński added, “These products provide new treatment opportunities, including the opportunity to perform cases using radial access, thanks to the long usable length catheters, the low-profile design, and the thin-strut stent design.

 

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

“When I first heard about this new approach “a stent design that is in compliance with the movability of the artery and the characteristics of the lesion, I was wondering. Now that we used the Qmedics stent systems, we are convinced the clinical evidence will show the benefits” added Dr. M Chlabicz.

 

 

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

The Second investigator Prof. Dr. med. Pierfrancesco Veroux, who is including patients at University Hospital of Catania, Italy added “I am enthusiastic to collect  clinical data on this new concept of a peripheral  stent system. Finally, we got some engineers who achieved to design a stent system that combines different radial forces with the movability characteristics of the arteries- I find this to be very interesting.“

 

 

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

Prof. Dr. Enrico Maria Marone at the Policlinico di Monza, Italy added : “Finally we have two different stents for different anatomies and lesions rather than one stent that fits all”.

 

 

 

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

Dr .Med. Frédéric Glauzer  – Hôpital Universitaires de Genève is waiting for the ethical committee approval , then also he and his team will start the enrollment .Dr Glauzer did already used the Qmedics EXIST stent system and was positively surprised of the behavior of the stent system

 

 

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

Dr. Adriaan Moelker – Erasmus University hospital Rotterdam is waiting for the ethical committee approval , then also he and his team will start the enrollment

 

 


2022
31. May 2022

First public announcement of the Horizon trial , were Qmedics “back to the basics concept” with the innovative stent design that takes into account both movability and lesion characteristics.

Treatment of the Femoro-Popliteal district with the innovative Exist NiTi Stent (QMEDICS) type Flex & Pull: the HORIZON clinical trial. Marone E.M.1, Rinaldi …

28. February 2022

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

The Horizon study will provide information on the long-term outcomes of the innovative EXIST NiTi self- expandable stent with its two types of …


2021
30. November 2021

Qmedics has obtained the Good Manufacturing Practices (GMP) certificate for its quality control, cleanroom facility and medical device manufacturing activities at its Swiss-based facility in Zürich- Flurlingen in November 2021

I am very pleased that Qmedics AG has been able to achieve the GMP certification. A GMP certification in general is granted to …

19. May 2021

Our publication Safety and Efficacy of Peripheral Embolization with EASYX Liquid Embolic Agent: A multicenter Prospective Study was accepted by the Journal of Vascular Interventional Radiology.

The use of cyanoacrylates, used for embolization for a long period of time, has decreased in the last decades, they are currently still …

28. February 2021

First EasyX Case report in Nicosia General Hospital, Cyprus

A 64-year Old patient presented to the nephrostomy department of Nicosia General Hospital with chronic allograft nephropathy and elevation of the inflammatory markers …

31. January 2021

A milestone reached EASYX I trial closed successfully

COVID-19 has created challenges in every aspects of healthcare. Due to the current pandemic, the medical device industry has been under tremendous pressure …


2020
31. August 2020

Qmedics Peripheral stent system family

After two and a half years of hard work finally we present the new peripheral stent family. It was a difficult path: The …

30. July 2020

PTA Qmedics product family Manatee-Naga-Nova is launched

The rise in the prevalence of cardiovascular diseases and peripheral vascular diseases, adaptation to a sedentary lifestyle, better healthcare facilities are key factors …


2019
30. September 2019

Qmedics achieved to close with success the first investigator meeting

“Horizon” Clinical investigation of the Qmedics Exist NiTi Stent portfolio with the Flex & Pull type in adults with Peripheral Artery Disease (PAD). …

31. July 2019

NEW PRODUCT added to our Portfolio

The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access …


2018
31. October 2018

New Organization for Qmedics

In 2016 the Board of Directors decided to sell the sister company of Qmedics, who was at the same time the biggest customer …

28. September 2018

Qmedics team at Cirse

Our travel did start with a strike of the taxi drivers, a delay in our shipment of workshop material- but as a team …

31. July 2018

First workshop: Endovascular treatments of PAD

With the organization of workshops the professionals get to understand the two stent types “ Pull & Flex”. The first workshop “Endovascular treatments …

30. March 2018

Exist & Manatee launched in “Der Schweiz”

As a Swiss company we are very pleased that our improved QM1 “Exist” a product entirely developed at our facility “made in Switzerland” …

3. January 2018

LINC congress: Presentation of our innovative product portfolio

Already a whole year qmedics R&D engineers are working on this concept and with success. The Finite element analysis (FEA), the bench testing …


2017
22. December 2017

Qmedics receives DIN EN ISO 13485:2016 Certificate

Qmedics is proud to announce its DIN EN ISO 13485:2016 certification. The company is now in the right to develop, manufacture and market …


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