Keystone hopes approval slots into place

The Triguard 3 device, developed by Keystone Heart as a way to catch embolic debris caused by transcatheter valve implantation, did not get a rapturous reception from an FDA panel yesterday. The adcom was unusual in that Keystone is seeking not a PMA but a 510(k) clearance, using Boston Scientific’s similar Sentinel as a predicate. As is typical with clearance panels, there were no votes on safety or efficacy, and panellists declined to pronounce on whether Triguard 3 was substantially equivalent to Sentinel, with some stating the data were insufficient and one saying patients who got the device did worse clinically than control subjects, who underwent unprotected valve implantation. Data from the pivotal Reflect II study back this up: the 30-day stroke rate was numerically higher with Keystone’s device than without. But there is a twist in the tale. Sentinel’s pivotal trial also failed to show that the product prevented new strokes, and it was approved by the FDA anyway. Its maker, Claret Medical, was acquired by Boston for $220m in 2018. Keystone is unlikely to be bought, though – it is a subsidiary of the Hong Kong-based Venus Medtech, which has a market cap of $2.5bn.