Boston Scientific Discontinues Flagship TAVR Implant

In a move that surprised the industry this morning, Boston Scientific announced that it was pulling its flagship LOTUS EDGE transcatheter aortic valve replacement (“TAVR”) device from the market.

The discontinuation comes in the form of a global, voluntary recall of all unused inventory of the system.  The decision was prompted by the complexities involved with the product’s delivery mechanism. The Company noted that the recall was not due to any safety issues related to the valve itself.

This appears to be a decision to stop investing in the platform where the additional product development, training and other work would have been prohibitive. Boston Scientific is shifting its focus to to the Company’s Acurate neo2 aortic valve system and Sentinel cerebral embolic protection system also used in TAVR procedures.

The company said the decision will likely cause a $225 million to $300 million pre-tax charge.

Boston Scientific’s share of the high growth $2.5 billion TAVR market is nominal compared to behemoths Medtronic and Edwards LifeSciences.  Nonetheless, shares in Boston Scientific were down approximately 9-10% throughout the morning while Edwards share price gained 3.5%.