When a news station in Indiana, WTHR Indianapolis, recently aired a brief segment about a new procedure from Aspire Medical (Sunnyvale, California) to help sleep apnea patients, the company thought the story might garner some patient interest in the U.S. clinical trial of its Advance System.
But Aspire was somewhat startled at just exactly how much interest the news segment sparked in its Advance trial, being conducted under an investigational device exemption (IDE) and enrolling up to 40 patients at up to five investigational sites in the U.S.
The company's Advance System is an implantable, minimally invasive device designed to treat tongue base obstruction for patients with obstructive sleep apnea (OSA), which is caused by the collapse of the upper airway during sleep.
Mike Dineen, VP of marketing and business development for Aspire Medical, told Medical Device Daily that since the news segment aired in Indianapolis, the company's web site has received 200-300 patient hits and that it has been "hit constantly" with phone calls from patients wanting to be a part of the trial.
The response to the story would appear to indicate how widespread the problems of OSA are and the patient demand, especially, for a minimally invasive treatment such as Aspire's Advance System.
"It's a huge market," Dineen said. "Physicians and patients both are really looking for something that's minimally invasive and something that treats the tongue base."
The first patient to receive the treatment, Dan Jackson, was enrolled recently at an outpatient surgery center affiliated with St. Vincent Hospital (Indianapolis), and he is "doing very well," Dineen said. The procedure was performed by Tod Huntley, MD, FACS of Head & Neck Surgery Associates (Indianapolis).
"We are pleased with the ease of the Advance procedure. It is simpler to perform and is less invasive than other OSA surgeries, and thus far the patient has had minimal discomfort and no complications from it. In fact, he was back at work two days after the procedure," Huntley said in a statement. "For years we have been looking for effective solutions for sleep apnea that are more tolerable to patients, and if this procedure proves to be as effective as the preliminary data suggest, I could see it becoming a first line of therapy in the treatment of this widespread and significant medical problem."
Dineen said patients with OSA wake up several times a night gasping for air because they are essentially being choked by their tongue. Within the past 30 years he said people have become increasingly aware of the co-morbidities associated with the sleep disorder, in particular cardiovascular diseases such as heart disease and sudden cardiac arrest.
Aspire points to figures indicating that at least 17 million people in the U.S. have moderate to severe OSA, characterized by heavy snoring, airway blockage and those frequent awakenings.
"Patients are really, really cued into this — this is really a patient-driven opportunity for us," Dineen said.
The most common treatment today for OSA is continuous positive airway pressure (CPAP), which involves a mask the patient has to wear on their nose while they sleep at night that forces air down their throat. Not the most comfortable therapy and not always a solution.
"The problem with CPAP is most patients can't tolerate it — you can imagine what it would be like to go to sleep with an air pump on your nose," Dineen said.
The alternative is surgery, he noted, but surgical options for these patients are very invasive, costly and most procedures do not treat the base of the tongue. The recovery time for patients who undergo these procedures can be up to 10 days to two weeks.
"So what we're doing, the Advance System is the first minimally invasive procedure to treat the base of the tongue in sleep apnea," Dineen told MDD, adding that the procedure — usually only taking about 45 minutes — is done in an out-patient surgery center and has a relatively short recovery time.
The treatment includes a device surgically implanted in the tongue and lower jaw. The purpose of the implant, Aspire said, is to prevent obstruction of the upper airway, thereby improving breathing during sleep. Once implanted, the system can be adjusted to an individual patient's needs, either during or after surgery.
"It's a tongue implant so the most common question we hear is, 'Is this going to affect my speech or swallowing?' and it doesn't," Dineen said.
The company also has an ongoing trial in Europe with the Advance, which he said so far has yielded promising results.
"Based on our prior experience with the Advance System, we are quite pleased with the performance of the product," said Roseanne Varner, president/CEO of Aspire. "Treatment of obstructive sleep apnea is a significant and growing unmet clinical need. Initiating the Advance trial in the U.S. is an important milestone as we develop minimally invasive, effective solutions for moderate to severe OSA. We believe that the Advance System will provide an important new therapeutic option to physicians treating OSA patients."
Upon completion of the IDE trial, Aspire plans to seek FDA approval. Assuming that approval, the company is targeting a U.S. commercial launch in late 2008 or early 2009.
Aspire, founded in 2004 and privately held, company focused on developing MIS treatments for OSA.