Questions Persist for St. Jude

ByHeather Ingrassia:On Friday, March 8th St. Jude Medical (

By Vatalyst: Over $17.5 billion is spent annually in the U.S. on major cardiovascular device implant procedures, which include coronary stents, heart pacemakers, and Implantable Cardioverter Defibrillators (ICDs).

Medical device maker St. Jude Medical says it received a warning letter from the FDA about manufacturing and quality-control problems at its plant in Sylmar.Medical device maker St.

By Trefis: Boston Scientific's (BSX) stock has zoomed 10% higher this week in part due to the news that the FDA has raised fresh concerns about the defibrillator leads -- leads connect an implantable heart defibrillator device to the heart -- from St. Jude Medical (

St.

By EP Vantage:St. Jude Medical is unlikely to be able to secure U.S. approval for its Amplatzer device, a tiny mesh plug used to close holes in the heart, after it failed in two late-stage trials. The firm still intends to file for FDA approval, but will now have to run the gauntlet of an advisory committee at the very least.

The safety questions that dogged device makers years ago are resurfacing amid a controversy over how St. Jude Medical handled disclosures about a wire that connects a defibrillator to a patient’s heart.

Medtronic has rejected a material similar to the one St. Jude Medical uses in its heart devices, raising more questions about its safety.