One day in late November, the U.S. Food and Drug Administration approved St. Jude Medical's Unify Quadra cardiac defibrillator and Quartet four-electrode lead. Just three days later, surgeons at Abbott Northwestern Hospital in Minneapolis implanted the device in Terrie Pearson of Farmington.
Such quick turnaround shouldn't be surprising. At a time when FDA approval can take years and product development and trials can cost millions, it behooves a device manufacturer to begin recouping its investment as soon as possible.
"This has been a long time coming," said Dr. Mark Carlson, chief medical officer of St. Jude's cardiac rhythm management division.
The Quadra and Quartet by Little Canada-based St. Jude are the industry's first quadripolar pacing system, which allows cardiologists to better manage cardiac resynchronization therapy, St. Jude officials say.
Analysts add that the system should boost St. Jude's fortunes at a pivotal time. The FDA recently issued a recall of St. Jude's Riata defibrillation leads, saying the wires are at risk of poking through their insulation.
Tao Levy of Collins Stewart said Quadra and Quartet are "very important" to St. Jude's immediate growth prospects. "Clinicians are eager to try this new lead, and it will improve STJ's market share in this category of CRT-Defibrillators," Levy said.
On the day FDA approval was announced, St. Jude's stock jumped 8 percent.
How it works
Cardiac resynchronization therapy defibrillators (CRT-D) are implanted in the chest and usually connected to the heart with three wires, or leads. The device stimulates both of the heart's lower chambers so they are "synchronized" and pump blood to the body more efficiently. The devices also can defibrillate or shock the heart if necessary.
St. Jude's device has four electrodes on the lead that is placed on the left ventricle. The company says that simplifies the implant procedure and minimizes post-surgery complications.
One such complication is stimulation of the phrenic nerve, which runs near the left ventricle. The nerve, which stimulates the diaphragm, can be affected by CRT-Ds and a patient can experience something like hiccups, Carlson said.
Another complication is scar tissue on the heart, which can inhibit electrical impulses from the device to the heart.
Having more electrodes allows physicians to work around such challenges without the risks of additional surgery, Carlson said. "We simply have more choices of where that electrical impulse can stimulate the heart," he said. "We can test and figure out which configuration works the best."
First to use
Allina's hospitals and clinics were the first to use the new St. Jude device in Minnesota. Abbott's Minneapolis Heart Institute and St. Paul's United Heart and Vascular Clinic at United Hospital wasted no time.
According to Dr. Charles Gomick, director of the heart rhythm section at the Minneapolis Heart Institute, Allina is among the first in the country to implant the device. "We recognize the advancements found in St. Jude Medical's latest CRT device and are excited to have the Unify Quadra CRT-D as an option for our patients," Gomick said.
Pearson, who works at the middle school in Farmington and is the 59-year-old mother of three adult children, found out that she had a congenital heart defect about five years ago. But "just recently, I found out about the seriousness of it," she said.
She had surgery to insert the device -- "about the size of a credit card" -- on Dec. 2 and was out of the hospital the next day.
"They suggested my quality of life would be better," she said. "When I got out, I said, 'Wait a minute. I do feel the difference. I do feel more energy and I do have more color.'"
She also thinks it's a little funny that she was among the first to use new technology. "Someone joked that I should be the last person to have this," Pearson said. "I can hardly type."
James Walsh • 612-673-7428