Bentley recently announced that it has been granted TÜV certification for two of its bridging stent products.
One certificate is for the Bentley BeGraft stent, which a press release notes makes it the world’s first on-label bridging device. The second is for the newly developed BeFlared—the first-to-market dedicated bridging stent for fenestrated endovascular aneurysm repair (FEVAR), according to Bentley.
“For more than 15 years, interventional radiologists and endovascular surgeons around the globe have performed FEVAR procedures with off-label stents. I am very happy that now the BeGraft is certified for use as a bridging stent. The BeGraft has successfully proven to be a means of choice when treating patients with challenging aortic aneurysms,” said Eric Verhoeven (Paracelsus Medical University Nuremberg, Nuremberg, Germany). Starting in 2021, Verhoeven conducted a multicentre clinical trial using the BeGraft in FEVAR procedures with more than 100 patients at 10 participating study centres. The positive results of this study paved the way for the certification initiated by Bentley, a press release notes.
“This certificate for the extended indication of our BeGraft stent graft system certainly is a milestone and improves our competitive edge in serving hospitals, physicians and patients with reliable endovascular solutions. Yet in face of the ever-rising need for FEVAR procedures in aortic repair, we also heavily invested in the development of the next-generation bridging stent dedicated to FEVAR procedures: the BeFlared. It has now received CE certification for use in FEVAR procedures,” Bentley’s CEO Sebastian Büchert remarked.
The certification of the BeFlared is the result of more than four years of development work by the Bentley team. It was initiated by Bentley’s co-founder Miko Obradovic who came up with the principal idea of a product simplifying bridging stent placement after being present at FEVAR procedures. The project team then developed the BeFlared in cooperation with Bentley’s long-standing scientific advisor Stéphan Haulon (Hôpital Marie Lannelongue, GHPSJ, Paris, France) together with a team of other international endovascular specialists.
As a dedicated bridging stent, the BeFlared connects the fenestrations of aortic prostheses to the patient’s renal and visceral arteries, a press release details. It consists of a uniquely shaped balloon on which the stent is mounted. The tapered shape of the balloon seals the BeFlared stent within the fenestration. A third X-ray marker at the point of the fenestration allows precise positioning of the stent. The release notes that these two features permit accurate deployment in one step, which is “decisive” to prevent future complications such as endoleaks.
Bentley shares that, in the coming weeks, selected clinical centres will be implanting the company’s new covered stents for FEVAR procedures. The official market launch is planned at the upcoming Leipzig Interventional Course (LINC; 28–30 January 2025, Leipzig, Germany).
