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. 

Selected cerebral embolic protection devices
Company Device Clinical data Status
Boston Scientific Sentinel Pivotal trial: MACCE rate 7.3% vs 9.9% with control (p=0.41); new lesion volume 102.8mm3 vs 178mm3 with control (p=0.33) CE marked 2014; FDA cleared Jun 2021
Edwards Lifesciences Embrella  Pilot trial: total lesion volume 305mm3, vs 180mm3 with control (p=0.909) CE marked 2010; FDA clearance not sought
Keystone Heart (Venus Medtech) Triguard 3  Pivotal trial: stroke rate 8.3% vs 5.3% with control (p=0.57) CE marked 2020; FDA decision pending
Emboline Emboliner  Open-label trial: MACCE rate 6.5% US pivotal trial planned
Source: Evaluate Medtech, company websites, JACC: Cardiovascular Interventions.

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