The first patient has been enrolled in a postmarket clinical follow-up (PMCF) study of the BeYond venous self-expanding stent system (Bentley), a press release states. The stent was launched in a selection of venous centres across Europe in late 2020.
Michael Lichtenberg, (Karolinen Hospital, Arnsberg, Germany) is the coordinating investigator of this prospective, single-arm, multicentre PMCF study. Also involved are seven other investigators from venous centres across Europe: Houman Jalaie (RWTH Aachen, Aachen, Germany), Rick de Graaf (Friedrichshafen Hospital, Friedrichshafen, Germany), Christian Erbel (Heidelberg University Hospital, Heidelberg, Germany), Oliver Schlager (Vienna University Hospital, Vienna, Austria), Prakash Saha (Guy’s and St Thomas’ Hospital, London, UK) and Gerry O’Sullivan (University Hospital Galway, Galway, Ireland).
A press release states that 110 patients will be enrolled in the study in order to assess long-term safety and efficacy of the BeYond venous in acute and chronic venous settings. Patients will be followed up over a 24-month period.
“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,” Lichtenberg 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,” he adds.
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 10–18 mm and lengths up to 150 mm. With its optimised 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 Martin Schirling, head of the Clinical Affairs department at Bentley. “Nowadays, it is essential to make a product reliable by showing favourable long-term results. This is where we put our focus on.”