Having launched the BeYond Venous Self-Expanding Stent System to a selection of renowned venous centres in Europe in late 2020, Bentley announced the successful enrollment of the first patient in their Post-Market Clinical Follow-Up (PMCF) study this week.
Dr. Michael Lichtenberg, Karolinen-Hospital Arnsberg, Germany, is the coordinating investigator of this prospective, single arm, multi-centre PMCF study. Also involved are seven other leading venous centres across Europe: Houman Jalaie (RWTH Aachen, Germany), Rick de Graaf (Friedrichshafen Hospital, Germany), Christian Erbel (Heidelberg University Hospital, Germany), Oliver Schlager (Vienna University Hospital, Austria), Prakash Saha (Guy´s and St Thomas´, London, UK) and Gerry O´Sullivan (Galway, Ireland).
110 patients will be enrolled with a 24M follow-up to assess long-term safety and efficacy of the BeYond Venous in acute and chronic venous settings.
“With the BeYond Venous another promising device is available now in the growing field of venous interventions. The study aims to prove not only good patency results in the long-term, but also to gain evidence that this dedicated venous stent withstands all challenging venous pathologies,”, he mentions. “There is no ideal venous stent yet, but every new device is a complementary addition to what is already available and gives us as users even more options to treat every patient´s anatomy individually,” Lichtenberg added.
The BeYond Venous Self-Expanding Stent System is the first Nitinol stent in Bentley´s product portfolio, indicated for acute and chronic symptomatic obstructions of the femoral or iliac vein. It comes with a wide range of diameters from 10 mm to 18 mm and lengths up to 150 mm. With its optimized balance between radial force and flexibility, the BeYond Venous Self-Expanding Stent System allows accurate positioning and exact landing zones in venous interventions.
“We are looking forward to another great cooperation with regards to clinical evidence. It is Bentley´s aim to ground the clinical success of every product on a solid base of proven data,” states Dr. Martin Schirling, head of Clinical Affairs department at Bentley. “Nowadays, it´s essential to make a product reliable by showing favorable long-term results. This is where we put our focus on.”
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