Aspire Medical (Sunnyvale, California) reported initial clinical trial use in the U.S. of its Advance System, an implantable, minimally invasive device designed to treat tongue-base obstruction for patients with obstructive sleep apnea (OSA). The first patient to receive the treatment was enrolled at an outpatient surgery center affiliated with St. Vincent Hospital (Indianapolis).

The procedure is performed by an otolaryngologist and involves placement of a small implant in the tongue. The system can then be adjusted to an individual patient’s needs performed at the time of device placement, at a later date or on multiple occasions if needed.

The Advance Trial, conducted under an investigational device exemption (IDE), will enroll up to 40 patients at up to five investigational sites in the U.S. The procedure was performed by Tod Huntley, MD of Head & Neck Surgery Associates.

Huntley said the Advance procedure “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.

“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 . . . .”

B. Tucker Woodson, MD, of the Medical College of Wisconsin (Milwaukee) is principal investigator.

Upon completion of the trial, Aspire said it plans to seek FDA approval to commercialize the Advance System in the U.S. Aspire said it is targeting U.S. commercial launch in late 2008 or early 2009, subject to the receipt of necessary regulatory approvals. The company said its clinical investigation in Europe has so far shown “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. nitiating the Advance trial in the U.S. is an important milestone as we develop minimally invasive, effective solutions for moderate to severe OSA.”

Aspire Medical, privately held, was founded in 2004.