EW Edwards Lifesciences Corp

$EW FDA approved the AUTUS size-adjustable valve, the first surgical pulmonary valve built specifically for pediatric congenital heart disease (company release, Oct 1). The design is the change. In kids, valve replacement is not a one-time event: children outgrow fixed valves and face repeat open-heart surgeries. AUTUS expands as the child grows through a minimally invasive transcatheter procedure. The proof ran inside the pivotal trial. When two patients saw valve performance deteriorate as they grew, both valves were expanded successfully without repeat surgery. 62 patients across 12 sites: no deaths, no strokes, no valve thrombosis requiring treatment, 100% free of device-related complications through 30 days. Materials first too: the leaflets are ePTFE polymer rather than animal-derived tissue, the first US valve approved that way. Closed Friday around 85.49, about 11% below the July 96.29 high. Street consensus: Moderate Buy, average target near 100.

$EW investors: an open class action over alleged TAVR growth misstatements at Edwards Lifesciences. $39M settlement, roughly $0.66 a share before fees. Claim deadline is Dec 2. Details on Open Class Actions.

$EW Remember the insider cluster sale I flagged here on Aug 27 - 2 execs, 3 sells same day, zero confirming technical signal back then? Another insider sold Sep 11 (Lippis, ~54K). This time it's different: Momentum Alignment just flipped Sell, stock down 2.8% Friday and 6% on the week. Golden Cross (367 days) still says the longer trend is intact. Coincidence, or did the cluster selling actually see this coming?