Aug 26, 2023

Medtech in a Minute: Abbott's Heart Valve Pivot, and More

Amanda Pedersen | Aug 07, 2023

In a move that comes about 5 months after FDA raised durability concerns about Abbott's Trifecta heart valves, the company has permanently withdrawn the devices from the market. FDA alerted healthcare providers in late February about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta with Glide Technology (Trifecta GT), which feature leaflets externally mounted to the valve frame. According to the agency, published literature suggests a higher cumulative incidence of early (five years or less) SVD for Trifecta valves compared to competing surgical aortic valves.

Not So Sweet Home Alabama

Baxter will reportedly cease production at its plant in Opelika, AL, affecting nearly 500 employees. Baxter leadership said the closure is not a reflection on the quality of the workforce or the business climate in Opelika, “but was brought on by global market conditions that have impacted demand and overseas competition.”

Unless Illumina wins its appeal in European Courts, the company will have to pay a $476 million (€432 million) fine over its 2021 acquisition of Grail. Illumina said it closed the deal in 2021 because the timeframe would have expired before the European Commission (EC) could reach a decision on the transaction. The EC accuses Illumina of strategically weighing the risk of a gun-jumping fine against the risk of having to pay a high break-up fee if it failed to takeover Grail. EC said the company also considered the potential profits it could obtain by jumping the gun, even if it were ultimately forced to divest Grail. After the EC ruled against the deal last year, Illumina reportedly put aside $453 million in anticipation of a fine. However, the company is appealing the EC's decision and, if successful, the fine would be nixed. A decision in that appeal is expected in late 2023 or early 2024.

The prescription digital therapeutics (PDT) company, which eliminated 35% of its workforce earlier this year, has scored FDA authorization of its PDT for type 2 diabetes. The authorization creates a new class of diabetes digital behavior therapeutic devices. The PDT is expected to launch in later this year.

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