The recently approved coated Derivo® 2heal® Embolization Device (DED 2H) appears promising for treating intracranial aneurysms, according to a preliminary study from Germany.
“We present our initial experience with the DED 2H in 10 consecutive procedures to treat 16 aneurysms, which, to our knowledge, is the first clinical study of this novel [device],” the investigators said. “The device was successfully deployed in 9/10 procedures, and a single device was sufficient in all successful cases.”
According to the researchers, the one case of failed stent deployment was a technical complication. “[T]he device could not be pushed through a Headway 27 catheter due to severe friction, most probably due to the tortuous vessel geometry.”
No clinical complications and procedural thromboembolic events were reported, nor were there any cases of aneurysm rupture or ischaemic stroke among patients who were followed up. All patients had a modified Rankin Score of 0 at discharge and at follow-up.
The researchers retrospectively reviewed data from nine consecutive patients (median age 57.5 years) treated with the DED 2H for 16 aneurysms across 10 procedures at a single tertiary care hospital between August 2022 and March 2023. [Interv Neuroradiol 2026;32:57-65]
Twelve aneurysms were in the para-ophtalmic internal carotid artery (ICA). The rest were in the cavernosal ICA, posterior communicating artery, posterior inferior cerebellar artery, and basilar artery trunk (one in each). In terms of morphology, 12 aneurysms were saccular, two were blister-like, one was lobulated, and the other was fusiform.
All aneurysms were unruptured, untreated, wide-necked, and not partially thrombosed. The median aneurysm size was 6.1 mm.
The device
“The DED 2H is the latest addition to the Derivo family of flow diverters … It is based on the second-generation DED, which has been completely redesigned in terms of fluoroscopic visibility, wire placement, and thickness to improve deployment and final wall apposition,” the researchers shared.
The DED 2H consists of nitinol composite wires, allowing treatment of vessels 1.5–8 mm in diameter. Both ends of the device are flared at a 25-degree angle to improve wall apposition, with a closed distal end to enhance device opening.
The device is coated with a nanotechnology called ‘Heal’, which converts fibrinogen molecules into fibrin to form a fibrin network over the entire stent surface, mimicking the final step of the clotting process. [Interv Neuroradiol 2024;30:170-174] “This fibrin-based coating is expected to be non-reactive in terms of coagulation, potentially resulting in reduced thrombogenicity,” they added.
A valuable addition to the toolkit
“Our preliminary experience with the DED 2H indicates that this device is a valuable addition to the neurointerventional armamentarium,” the investigators said. “Deployment of the device is typically smooth due to the flexible design of the flow diverter and delivery system. A single stent was sufficient to treat the target aneurysm in all cases. In addition, there were no thromboembolic complications.”
The researchers acknowledged certain limitations, such as the small sample size and lack of angiographic follow-up and long-term outcomes. The different aneurysm statuses, locations, and sizes may have also led to heterogeneity.
Further studies with mid- and long-term results are thus needed to validate the findings.