Re-classification of LGF now complete and looking to the future

Endovab is very happy to announce that the medical device re-classification process now is completed: The Liungman Guidewire Fixator CE mark Class 3 (MDD) is valid until May 2024.

We look forward to continuing to supply this key tool to all endovascular centres in Europe, which will help them make interventions in the aorta and the peripheral artery safer and in a shorter time.


The LGF clinical study is now published in INNOVATION - Technologies and Techniques in Cardiothoracic and Vascular Surgery. 
 
The study was conducted as a separate trial in ten patients undergoing endovascular aortic repair. The LGF was deployed in the Hypogastric artery from a cross over access. 3N of tension was applied to the guidewire to verify guidewire fixation. The LGF was then retrieved and the artery was inspected for any sign of trauma using angiography and a 30 days post operative CT-scan. 
 
Deployment was uneventful in all ten patients. Retrieval according to the intended instruction for use was performed in nine of the patients. In one patient, a coaxial catheterization was necessary. All devices withstood a retention force of 3 N.

 “This study was aimed to investigate and verify the pre-clinical results from porcine models, and the results are very similar, no dissection or vessel trauma so far. The device has been designed to produce an evenly distributed, radial force against the vessel wall, which reduces the risk for dissection. In my opinion dissection often occurs due to pointy tools, often guidewires, that penetrates the initima.” Says Krister Liungman, Founder and Head of Clinical at Endovab
 

Läs hela inlägget »
16/05/2018
Fenestrated aortic arch repair, from a pure femoral access!
13/11/2017
Dr David Deaton joins Endovab
09/11/2017
Clinical results presented at the Veith Symposium!
05/10/2017
Preloaded f-EVAR with pre-lining of fenestrations on table


The LGF clinical study is now published in INNOVATION - Technologies and Techniques in Cardiothoracic and Vascular Surgery. 
 
The study was conducted as a separate trial in ten patients undergoing endovascular aortic repair. The LGF was deployed in the Hypogastric artery from a cross over access. 3N of tension was applied to the guidewire to verify guidewire fixation. The LGF was then retrieved and the artery was inspected for any sign of trauma using angiography and a 30 days post operative CT-scan. 
 
Deployment was uneventful in all ten patients. Retrieval according to the intended instruction for use was performed in nine of the patients. In one patient, a coaxial catheterization was necessary. All devices withstood a retention force of 3 N.

 “This study was aimed to investigate and verify the pre-clinical results from porcine models, and the results are very similar, no dissection or vessel trauma so far. The device has been designed to produce an evenly distributed, radial force against the vessel wall, which reduces the risk for dissection. In my opinion dissection often occurs due to pointy tools, often guidewires, that penetrates the initima.” Says Krister Liungman, Founder and Head of Clinical at Endovab
 

Read the full post »
16/05/2018
Fenestrated aortic arch repair, from a pure femoral access!
13/11/2017
Dr David Deaton joins Endovab
09/11/2017
Clinical results presented at the Veith Symposium!
05/10/2017
Preloaded f-EVAR with pre-lining of fenestrations on table

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