Reva Medical has secured (PDF) the CE marking of its bioresorbable scaffold. The European regulatory nod clears Reva to push a device it thinks addresses some shortcomings of other products in the nascent but faltering bioresorbable scaffold sector.
Bioresorbable scaffolds were hailed as the next step in the innovation chain after bare metal stents and drug-eluting variants. But Abbott stopped sales of its bioresorbable scaffold last year in the face of low sales and safety concerns. Around the same time, Boston Scientific dealt the sector a blow by scrapping its bioresorbable stent program.
Reva has pushed on as its larger rivals have dropped out of the race, but its first-generation scaffold is still finding its feet. Commercial sales of the device—Fantom—got underway last year. By the third quarter, Reva was shipping $105,000 worth of the scaffolds and booking $17,000 of revenue.
The commercial push will now benefit from a revised version of the scaffold, Fantom Encore. The big difference between the two scaffolds is the thickness of the struts, which Reva has shrunken down to 95 microns. That is closer to the 83-micron struts of Abbott’s drug-eluting stent Xience than the 150-micron struts of the healthcare giant’s now-dropped bioresorbable scaffold.
Matthias Lutz, M.D., the physician who performed the first implantation of Fantom Encore, thinks the thin struts give the device an edge.
“Fantom Encore has the thinnest strut profile of any available bioresorbable scaffold in the 2.5-millimeter diameter size. A thinner profile can improve ease-of-use during the implant procedure and vessel healing following the procedure,” Lutz said in a statement. “My experience with Fantom Encore was a successful implantation procedure, and it was easy to see with X-ray.”
The ease of seeing the device under X-ray is one of the ways Fantom differs from Abbott’s device, which was radiolucent. To mitigate the transparency of the scaffold to X-rays, Abbott embedded four radiopaque markers in the device but it remained harder to visualize than drug-eluting products. The design of the Fantom line addresses this problem.
Reva now faces the task of persuading doctors and healthcare systems that its products unlock the mooted benefits of bioresorbable scaffolds over metal drug-eluting devices, such as late lumen enlargement and coronary vasomotion. And that they are free from the limitations and failings that held back first-generation products.
In parallel, Reva is working to bag CE marks for 3.0- and 3.5-millimeter versions of the device.