Neurotech Sleep Apnea Market Moves Toward Maturity

by James Cavuoto, editor

The neurotechnology market for devices to treat obstructive sleep apnea moved closer to maturity in recent weeks as two vendors made major announcements. As competition heats up in this new space, a whole new class of patients and therapists will be exposed to the benefits of neurostimulation interventions.

Earlier this month, ImThera Medical Inc. announced European CE Mark approval of its aura6000 system for the treatment of OSA. The aura6000 system uses ImThera’s patented Targeted Hypoglossal Neurostimulation method to focus neurostimulation on certain muscles of the tongue during sleep.

“The aura6000 is a new therapeutic option that has proven efficient in obstructive sleep apnea patients who cannot comply with CPAP,” said Daniel Rodenstein, of the department of Pneumology at Université Catholique de Louvain, St. Luc Hospital, in Belgium and principal investigator of the ImThera study. “Patients that tried and failed CPAP and then were implanted with the aura6000 tell me that this therapy has allowed them to recover freedom to sleep undisturbed and to resume a normal life.”

The aura6000 system consists of an 11 cm3 rechargeable neurostimulator that generates electrical pulses and a lead with multiple electrodes that delivers the pulses to the hypoglossal nerve, which controls all muscles of the tongue. Patients use a remote control and charger to turn the system on/off and to recharge the neurostimulator.

“We are pleased to have reached this milestone and look forward to making this therapy available to patients at key European centers of excellence in the second half of 2012,” said Marcelo Lima, chairman, president and CEO of ImThera Medical. “This new therapy will prove to be an important tool for physicians to consider for the treatment of OSA.” The limited launch of these systems in Europe represents ImThera Medical’s first commercial efforts.

The prevalence of obstructive sleep apnea syndrome has been extensively studied in recent decades and it has been estimated that between 1 percent and over 6 percent of the adult population suffers from OSA. Approximately 20 percent of OSA patients in the first world have the benefit of some type of treatment. CPAP devices are the established therapy for moderate to severe OSA, however studies show that only 54 percent of patients are able to comply to this method. Left untreated, OSA may lead to many serious consequences, including: hypertension, congestive heart failure, atrial fibrillation, stroke, type II diabetes, weight gain, depression, and traffic accidents.

Another OSA vendor, Apnex Medical, announced that three articles have recently been published showing positive results from its Hypoglossal Nerve Stimulation system clinical studies in the U.S. and Australia.

The most recent article by Goding et al. was published online last month in the Otolaryngology Head Neck Surgery journal. This study examined the acute effects of HGNS therapy using fluoroscopic imaging, and it showed that the HGNS system opened patients’ airways not only at the base of the tongue, but throughout the airway in patients with OSA.

“Using fluoroscopy, we can clearly see that HGNS therapy has a positive effect in multiple parts of the airway in the majority of patients,” said Goding, an associate professor of otolaryngology at the University of Minnesota. “These findings are important because they indicate that the HGNS therapy has the potential to treat a broad range of patients with OSA, not just those with isolated tongue-based prolapse.”

A second article was recently published by Alan Schwartz in the American Journal of Respiratory and Critical Care Medicine. It showed the HGNS System increased airflow in all subjects without arousing patients from sleep. It also demonstrated that increases in airflow from the HGNS system provided substantial relief of upper airway obstruction during sleep in patients with a wide range of OSA disease severity.

A third article was published in Sleep by Peter Eastwood et al. in November 2011 on the six-month results of the Australian feasibility study. The HGNS System was found to have a favorable safety and efficacy profile. Patients had significant decreases in their OSA severity and reductions in their OSA-associated symptoms.

“We are very pleased that the results from the Apnex feasibility trials have now resulted in three peer-reviewed publications in leading medical journals. These recent findings demonstrate how the HGNS system works and that the therapy can be effective in treating moderate-to-severe OSA,” said Chas McKhann, Apnex Medical president and CEO. “We are focusing on further evaluation of the HGNS system in the Apnex Clinical Study, a randomized clinical trial of the HGNS system that is enrolling patients in the U.S., Australia, and in select countries in Europe.”



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