Medtronic's Pillar Palatal Implant System, which stiffens the soft palate with the goal of reducing snoring, has been approved for expanded use.
It would be an exaggeration to say that Patrick DeNucci's snoring endangered his marriage. But quieting his nightly rumble has saved him "a few elbows to the head."
"It's not eliminated," said DeNucci, 61, of Eden Prairie, who has been married for 28 years. "But Judy would tell you it's much better."
DeNucci's doctor, Philip Rapport, thinks life -- and sleep -- could also get better for more of the estimated 90 million snoring American adults now that the U.S. Food and Drug Administration has approved more extensive use of Medtronic's Pillar Palatal Implant System. The procedure, in which thin polyester implants less than an inch long are inserted into a patient's soft palate, stiffens the palate tissue and lessens the vibrations that result in snoring.
Doctors now can insert up to five Pillar implants into the soft palate to treat snoring. They had been limited to three. Rapport said this will allow patients with wider or thicker palates to potentially see better results.
"We have found that, for about two-thirds of patients, snoring intensity was reduced by 50 percent. And about 80 percent of bed partners reported satisfaction," Rapport said Tuesday at his Edina office. "But there were people who were not satisfied."
The Pillar implants are just one of many snoring remedies, from mouth guards to laser surgery, designed to give people desperately needed relief from the chainsaws in their heads. About 45,000 people worldwide have had the Pillar devices implanted, which takes about 20 minutes and requires only a local anesthetic. The doctor inserts the devices using a tool that looks a little like a toy gun with a long sterile metal tip at the end. Only a handful of ear, nose and throat doctors in the Twin Cities are trained to implant the device. Rapport has been performing the procedure for about a decade.
He said he has no financial connection to Medtronic and receives no money from the firm.
Medtronic officials didn't make any executives available to talk about the device. But information on the company website compared Pillar implants to other surgical procedures, calling it "minimally invasive. The Pillar Procedure is done in one brief office visit. Other palatal procedures may require multiple treatments over a series of visits, or an operating room procedure."
It also said the procedure involved "minimal discomfort. The Pillar Procedure doesn't involve the permanent surgical removal of tissue or require lasers, radiofrequency energy, or chemicals to destroy tissue." The company says that "most patients resume normal diet and activities the same day."
And, unlike mouth guards or nasal strips or special masks, the Pillar procedure is permanent. Rapport said most patients don't notice the devices once they are implanted. They do begin noticing a difference in their snoring in a few weeks, he said, although it can take a couple of months for scar tissue to form around the implants and stiffen the palate tissue.
The Pillar device was originally approved by the FDA in 2004.
Limiting the Pillar's potential popularity, Rapport acknowledged, is that most insurance companies will not pay for it. It can cost $1,500 to $2,100, depending on how many of the implants are used.
Pillar palatal implants also are used to treat mild to moderate sleep apnea, although the FDA has approved only the implantation of up to three devices to treat that condition. The doctor said he would like to see a study looking at the impact of implanting up to five devices.
"Once the information became available that four was better or that five was better, we started talking to patients," Rapport said. "What we really are hearing is that this is resulting in improved sleep."
Both for the patient -- and the person who shares a bed with them.
"The real key is when the bed partner notices," Rapport said. "I had one spouse tell me 'This isn't working.' Then, a couple nights later, say: 'Oh my gosh, he's silent.'"
However, a search regarding the procedure in a handful of online forums found that while several people said the device improved their snoring, some said that it did not. Some said they still needed to use other remedies in addition to Pillar to get a good night's sleep.
Always a snorer
DeNucci, an airline pilot with two sons and an attention-grabbing pug named Rudy, has been a snorer as long as he can remember. When his kids were little and Judy stayed at home, she could make up for the lack of sleep caused by his nocturnal noise by taking naps.
But when she started working outside the home again, he said, his snoring started causing problems.
DeNucci knew Rapport from earlier procedures, one to remove a benign tumor from his inner ear and one to repair a deviated septum. So, when Rapport suggested a potential solution to his snoring, DeNucci said he wasall for it.
"He said: 'You know what? There's something that's kind of new,'" DeNucci said Rapport told him in 2003. For the past decade, life has been better for DeNucci, his wife and others. DeNucci has three Pillar implants.
"When we'd go up golfing with the brothers, they'd say: 'Who's sleeping with Pat?'" DeNucci said.
"I sleep so much better."
James Walsh • 612-673-7428