A recall has been issued by Boston Scientific for Lotus Edge Aortic Valve System, which are used in transcatheter aortic valve replacement (TAVR) surgeries, and the manufacturer indicates the entire product line will be removed from the market amid problems with its delivery system.
The FDA announced the Boston Scientific Lotus Edge recall on January 11, but the company initially told investors and customers about the decision to discontinue the product last year. It is unclear what the specific problem was with the delivery system, but the company claims there were no problems with the valves themselves.
“While we have been pleased with the benefits of the Lotus Edge valve has provided to patients, we have been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve,” Boston Scientific Chairman and Chief Executive officer Mike Mahoney said in the company’s announcement. “The complexity of the deliver system, manufacturing challenges, the continued need for further technical enhancements, and current market adoption rates led us to the difficult decision to stop investing in the Lotus Edge platform.”
The company expects the recall to cost $225 million to $300 million; which will be calculated into its 2020 fourth quarter earnings. However, Boston Scientific officials maintain there is no risk to patients who already have the Lotus Edge aortic valve system implanted.
TAVR is a type of heart procedure which allows the surgeon to replace the heart valve by threading it through an artery in the leg instead of via open chest surgery. It places the valve over the damaged aortic valve in a less invasive procedure.
Initially, TAVR was approved only in high risk patients who were frail or couldn’t undergo open heart surgery because the procedure carried such high risks, however, it has been used more broadly over time. This has raised concerns because the durability of the heart valves was untested for use in younger patients who would outlive the devices; which were designed to last 10 years, not 30 years or more.
A recent study indicated many TAVR complications could be avoided if imaging techniques, like multidetector computed topography (MDCT) were utilized. That study also found using an experienced surgeon and focusing on real-time ultrasound guidance could help prevent complications.
Other side effects of TAVR include the failure of a closure device, device embolization, coronary occlusion, and higher risk of stroke, putting many more patients at risk.