In a long-awaited development, Abbott Laboratories has received permission from the Food and Drug Administration to sell an implantable heart defibrillator that is compatible with magnetic resonance imaging (MRI) scanners.
Abbott, which acquired the St. Jude Medical portfolio of implantable defibrillators in January, said Friday that the FDA approved its Ellipse defibrillator, along with the wires used with the devices, as safe to use in MRI scans. St. Jude and Abbott had lost sizable market share in the market for defibrillators because they lacked the MRI-compatibility approval that competitors Medtronic and Boston Scientific have.
“We view this as highly positive news,” analysts with Stifel Nicolaus & Co. wrote in a note to Abbott investors. The analysts estimated that Abbott has lost at least 15 percentage points of U.S. defibrillator market share to competitors because of the MRI-safe product gap, but the company is now likely on track to regain much of that ground.
An implantable defibrillator is an advanced medical device that can deliver a powerful electric shock to restore a normal rhythm if it detects the patient’s heart beating erratically or too fast. About 300,000 of the devices are implanted each year worldwide. Hospitals tend to pay from $11,000 to $15,000 for each defibrillator, though prices can vary widely and are considered proprietary information.
When Minnesota-based St. Jude Medical was a stand-alone company, defibrillators were its largest product category in terms of revenue, accounting for nearly $1.6 billion in sales in 2015. Heart-rhythm devices like defibrillators and pacemakers account for about 8 percent of Abbott’s total sales, with implantable cardioverter defibrillators (ICDs) making up a third of that.
The MRI-compatibility approval for the Ellipse defibrillator means that patients who were previously implanted with the device can now undergo an MRI scan if they need one, Abbott said in a news release. The FDA has also approved Abbott’s Assurity pacemaker for MRI compatibility, as well as several types of thin insulated wires that connect the machine to the heart, including the Tendril pacemaker lead and Durata and Optisure defibrillator leads.
Abbott is still seeking MRI-compatibility approvals for another standard ICD model called the Fortify, as well as a cardiac resynchronization therapy defibrillator (CRT-D). In addition, Abbott is working with the FDA to resolve a warning letter that was issued for the St. Jude manufacturing plant in Sylmar, Calif.
Robert Ford, executive vice president of medical devices at Abbott, said the FDA approvals for MRI-compatible devices since the close of Abbott’s acquisition of St. Jude showed that the new ownership was on track with its plans following the deal.
“The integration of St. Jude Medical into Abbott is going well,” Ford said in an e-mailed statement Monday. “Approvals like this are evidence of the good progress our teams are making to resolve open issues and expand the benefits of our products for patients.”