A new type of heart defibrillator that doesn't need to be connected to the heart with wires moved closer to approval in the United States with a positive review from an FDA advisory panel.
The device, called a subcutaneous implantable cardioverter defibrillator (S-ICD), was developed by Cameron Health Inc., a San Clemente, Calif.-based company that Boston Scientific Corp. is acquiring. ICDs ward off sudden cardiac arrest.
The Food and Drug Administration panel voted 7-1 Thursday that the benefits of the Cameron device outweigh the risks -- and 8-0 that it is safe. The device still has not been granted full approval in the United States.
But Kevin Hykes, Cameron's president and CEO, said the company anticipates approval in early 2013, if not sooner. "Obviously, we are thrilled with yesterday's result," Hykes said. "We are one step closer to bringing this to U.S. patients."
In a report Friday, Leerink Swann analyst Rick Wise called the Cameron defibrillator a "paradigm-changing technology" with a very large market potential.
Thom Gunderson, an analyst with Piper Jaffray & Co., estimates that the Cameron device could reach about 15 percent of the market and said FDA approval is expected.
Natick, Mass.-based Boston Scientific Corp., which employs about 5,000 people in the Twin Cities, said in March that it would exercise its option to buy Cameron Health. The deal is expected to close in the second or third quarter.
"I don't think that Boston Scientific would have gone through with this if it didn't have a good idea ahead of time that the clinical data were sound," Gunderson said.