Dive Brief:
- Edwards Lifesciences has asked customers to remove from inventory some delivery systems used for Sapien M3 transcatheter mitral valve replacement after receiving three reports of balloons bursting during inflation, the Food and Drug Administration said Thursday in an early alert.
- Edwards reported one death and one serious injury associated with the problem as of Oct. 5, when the device maker sent a letter to customers recommending they remove the Commander M systems from where they are used or sold and return them to the company.
- The issue could lead to an embolism or prevent the physician from retrieving the device through the guide sheath, requiring an additional intervention such as surgery, the FDA said. The potentially high-risk intervention carries a risk of serious adverse health consequences.
Dive Insight:
Four lots of the Commander M delivery systems are covered in the recall, the FDA said. Units with other lot numbers are not affected and can continue to be used.
The four lots represent less than 200 delivery systems, an Edwards spokesperson told MedTech Dive in an emailed statement. The company is working with customers to complete the product return and replacement process.
Leerink Partners analysts, in a note to clients, said the problem appeared to be batch-specific, rather than a broader platform issue, and predicted little financial impact to Edwards.
The company recently began to roll out Sapien M3 in the U.S. and Europe after receiving regulatory approval last year. The treatment is intended for patients who are too frail for a mitral valve repair procedure or open heart surgery. CEO Bernard Zovighian, on an earnings call in July, characterized initial feedback from physicians as “very good.”
Edwards’ transcatheter mitral and tricuspid therapies business, which includes Sapien M3, is a fast-growing though still relatively small segment for the company. Zovighian said sales of Sapien M3, along with the Pascal and Evoque platforms, exceeded expectations in the latest quarter. Edwards raised its sales forecast for the TMTT portfolio and said the business was on track to reach $2 billion in sales in 2030.
