The Oventus O2Vent® Optima Nylon Appliance

Current Issue , Product Reviews


Editor’s intro: As a hybrid appliance for the nasally compromised, the Oventus O2 Vent® Optima reduces negative pharyngeal pressure swings. Read Dr. John Viviano’s product study to discover how this nylon appliance meets this goal.

[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner width=”2/3″][vc_column_text]The Oventus O2Vent line of oral appliances recently added the O2Vent Optima. The Optima achieved 510k market clearance from the US Food and Drug Administration late this summer. The Optima is available in Canada, the US and Australia. The Oventus focus is on this newly available entry into market.

The original O2Vent, based on a Mono Block platform, incorporated an integrated oral breathing channel. It allowed for mandibular advancement, but this required lab participation. Chairside adjustable versions were then introduced; one based on a “TAP-Like” anterior midpoint attachment and a second based on a “Dorsal-Like” bi-lateral attachment – O2Vent® T and O2Vent® W.[/vc_column_text][/vc_column_inner][vc_column_inner width=”1/3″][vc_single_image image=”8820″ img_size=”medium” add_caption=”yes”][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_column_text]The latest addition to this lineup of appliances is the O2Vent Optima (Figure 1). It is designed and manufactured in a Computer Assisted Design and Computer Assisted Manufacturing (CADCAM) environment. It is best described as a hybrid appliance blending features of EMA and Narval devices with the integrated airway technology that is unique to Oventus oral appliances. The O2Vent Optima is made of PA2200 non-filled type 12 Polyamide Nylon, and is 3D Printed. As with all of the Oventus O2Vent appliances, mandibular advancement is provided along with the integrated proprietary airway technology which facilitates airflow even during velopharyngeal collapse. Mandibular advancement is achieved using Oventus proprietary medical grade Isothane connector bands developed specifically for the Optima. The O2Vent Optima is provided fully assembled with a 19 mm length connector band attached, customized to the patient needs. Two sets of connector bands are also provided to adjust advancement, each set consisting of 9 sizes ranging from 13-21. As with all appliances that utilize connector bands, once the optimum jaw posture is established, the advancement bands should be assessed monthly for elongation and replaced as necessary.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner width=”1/3″][vc_single_image image=”8821″ img_size=”medium” add_caption=”yes”][/vc_column_inner][vc_column_inner width=”1/3″][vc_single_image image=”8822″ img_size=”medium” add_caption=”yes”][/vc_column_inner][vc_column_inner width=”1/3″][vc_single_image image=”8823″ img_size=”medium”][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner width=”1/2″][vc_single_image image=”8824″ img_size=”large” add_caption=”yes”][/vc_column_inner][vc_column_inner width=”1/2″][vc_single_image image=”8825″ img_size=”large” add_caption=”yes”][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner][vc_column_text]

The O2Vent Optima Advantage

The Oventus O2Vent Optima can be very useful for chronic nasal obstructers, but it can also be used for non-nasal obstructers. A non-nasal obstructer will breathe normally through their nose while wearing the O2Vent Optima, however, during allergy or cold season, if their nasal breathing becomes temporarily compromised, they can also benefit from the airway option.

The premise of the O2Vent Optima is that the integrated airway channel by-passes the problematic velopharyngeal blockage area thus reducing negative pharyngeal pressure swings.

The ExVent is an accessory to the Optima device. The addition of this Positive End Expiratory Pressure (PEEP) valve helps to stabilize end expiratory pressure and maintain a positive airway pressure, preventing airway collapse (Figure 3). The ExVent Oral PEEP valve was introduced into the Australian and Canadian market in the spring of 2019. A multi-center trial with the ExVent is being conducted within the United States. For those PAP users struggling with Full Face Mask or those complaining of being starved for air, the ExVent offers a new therapeutic alternative.

Even more exciting are two innovative products currently in the research and development phase of product realization at Oventus Manufacturing in Brisbane, Australia. The first product is a combination of oral and nasal PEEP (Figure 4). The valve-pillow combination will attach to the O2Vent Optima or the O2Vent W appliances. It is being designed as a potential alternative treatment to CPAP. Patients may receive similar benefits without a 1lb. device, hose, mask and a power requirement.

The second product is a Connector that fits to CPAP (Figure 5). The PAP Connector will allow PAP to be applied without straps or the traditional PAP mask. Both of these innovative products are exciting and currently in development.

Why Focus On PEEP?

Since excessive increase in expiratory resistance can result in CO2 retention and patient awakening, successful therapy with PEEP devices depend on clinical expertise and selection of an appropriate resistance that allows the patient to continue breathing normally without significant CO2 retention. An ideal PEEP device should increase the expiratory pressure without compromising tidal volume, without causing CO2 retention, and without disturbing sleep.

The Oventus design is being developed as a platform which revolves around the notion of achieving optimal success with minimal intervention. The airway channel manages mouth breathing and by-passes the problematic velopharyngeal blockage area — this seems to be counter-intuitive considering what we know about the importance of nasal breathing. However, O2Vent appliances do not promote mouth breathing for a patient that has good nasal patency, they simply manage mouth breathing for those patients that have compromised nasal breathing. We know that there is a subset of patients that remain nasally compromised, even post-surgical intervention, and this may be the appliance of choice for them. However, this approach may benefit even those patients with optimum nasal breathing. There is some suggestion in the literature that an OSA Appliance is more likely to fail when the site of collapse is at the velopharynx (Figure 6). For patients who experience a velopharyngeal collapse, the oral breathing chamber facilitates air flow caudal to the velopharyngeal collapse, allowing for uninterrupted ventilation (Figure 7). Of course, nasal breathing is preferable for a number of reasons, one of the most important being the function of the nasal valve which moderates the rate of breathing. I wonder if the planned PEEP valve could in fact mimic this same function for oral breathing?[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner width=”1/3″][vc_column_text]

Show me the Evidence

In 2017, Lavery et al. published their findings on the safety and efficacy of the Oventus 02Vent Mono Block appliance for the management of Obstructive Sleep Apnea. The study had an n of 29, and incorporated participants of relatively severe OSA. They concluded that this device is safe, effective, and well tolerated with a clinically and statistically significant reduction in AHI of 62% as well as improvement in oxygen saturation. Neither efficacy nor response was reduced by the presence of nasal obstruction.

There has been much ongoing research activity in Australia regarding the Oventus O2Vent appliance platform. In October 2018, five abstracts were presented by various groups at the European Respiratory Society International Congress and the Sleep Down Under Annual Conference.[/vc_column_text][/vc_column_inner][vc_column_inner width=”2/3″][vc_single_image image=”8826″ img_size=”large” add_caption=”yes”][vc_single_image image=”8827″ img_size=”large” add_caption=”yes”][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner][vc_column_text]

The innovative and unique Oventus treatment platform is being designed to provide the ability to move through various steps of intervention, beginning with simply the base appliance, the Oventus O2Vent Optima, and progressing to the addition of a simple PEEP valve, a titratable Oral-nasal PEEP valve and finally the addition of PAP. The platform allows for adaptability to a next level of therapy if the current therapy step has less than desired efficacy of treatment such as residual apnea or persistent symptoms.

Although the science is early and immature, the concept is certainly intriguing and worthy of further investigation; by-passing the problematic velopharynx and/or nasal patency issues, the addition of Positive End Expiratory Pressure control and making this resistance titratable, and finally the addition of PAP if necessary. While we are waiting for more evidence, for those patients that are nasally compromised, this appliance may be the answer.[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_column_text]

Whether getting a hybrid appliance or other type of device, Dr. Erin E. Elliott notes that the delivery appointment is an exciting part of the process. Read: “Getting it into their hands: the delivery appointment.”