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.
ICDs are tiny devices that are implanted in the chest and shock the heart if they detect an irregular rhythm. In recent years, several brands of leads -- the wires that connect the device to the heart -- have been recalled due to a variety of potential defects.
Recently, a lead called Riata made by Little Canada-based St. Jude Medical Inc. has received attention in medical journals and among top heart doctors because wires might protrude through the lead's outer silicone insulation. If that occurs, the device may not deliver lifesaving therapy, or it could cause the patient to get unnecessary shocks.
With the S-ICD, doctors place the electrode just under the skin. When sudden cardiac arrest is detected, the electrode delivers a shock to the heart similar to external defibrillator paddles used by paramedics. Even without directly touching the heart, the shock can reset the heart's normal rhythm, according to Cameron.
Cameron Health conducted a 330-patient clinical trial to back up its application to the FDA and to determine whether its device is safe and effective. The product is approved for use in Europe. Hykes said the device has been implanted in more than 1,200 patients worldwide.
The S-ICD cannot substitute for lead-connected ICDs for all patients, Hykes acknowledged.
Gunderson said he expects that the Cameron ICD is the first of an eventual wave of lead-free devices.
"It's not gong to start out being the perfect device," he said. "You get a new technology on the market and you will get iterations and have improvements over time. The leadless kind of approach will fit into that -- over the course of 10 years, not 10 months."