Last November (2012) UK vascular device company Veryan Medical Ltd. gained CE mark approval for its clever BioMimics 3D vascular stent. Find that here. Now the UK’s National Institute for Health Research (NIHR) has issued a technical report pointing to the potential for the device, but resisting the temptation to offer a ringing endorsement.
The NIHR is a UK Department of Health funded body, intended to conduct research that informs decisions in healthcare. Its stated mission is to maintain a health research system in which the NHS supports outstanding individuals, working in world class facilities, conducting leading edge research focused on the needs of patients and the public.
In this vein (sorry) it’s focused its attention on a novel vascular stent with design features that set it aside from the competition.
Veryan Medical’s BioMimics 3D™ Stent differs from other stents intended for use in the peripheral vasculature by being effectively coiled rather than straight. What this means is that while its basic structure works in the same way as a conventional nitinol stent, Veryan claims its 3D cell-geometry design promotes spiral rather than laminar flow. Spiral flow is believed to be a more natural type of flow through arteries and may reduce restenosis in the artery by reducing the neointimal hyperplasia that is a hazard associated with implantable stents.
The NIHR’s technical report is referred to as a technology alert, issued by the organisations “horizon scanning centre”. In other words the NIHR drawing the attention of specialists and caregivers to what it believes is a technology with potential.
What the NIHR report does not do is make a recommendation. That’s not its purpose. It merely points to potential, covering itself with the “ifs and buts” that allow specialists to decide for themselves. For example, it says that “if shown through clinical trials to be safe and clinically effective compared with existing stents, using the BioMimics 3D™ Stent could improve patient outcomes in terms of reduction of subsequent restenosis and occlusion of the vessel.”
It also points to design features that facilitate longer stent lengths and may also protect against material fatigue and fracture, enhancing the longevity of the device.
The final big “if” says increasing use of the BioMimics 3D™ Stent “could” see a ramp in the proportion of patients who receive a stent, with an associated significant costs to healthcare services. These, it says, will need to be set against the potential savings if there is a reduction in further vessel occlusions.
If you think that’s all a bit wishy washy, skip to the last line where the information source is divulged.
“This Alert is based on a time-limited internet search.”
One is left wondering what the heck the point of all that was.