CPAP recall: Immediate solution available from Airway Management


Sleep Treatments | Sleep Review

Sleep professionals therefore indefinitely look for therapies that are immediately available. Oral devices are a well-known alternative to CPAP – however, some are not well validated in independent research studies, or are expensive or difficult to order, making their prescription risky for some doctors. But there is an accessible, well-researched, and affordable oral device that can treat your patients’ sleep apnea within a week of placing the order: myTAP from Airway Management, Inc.

“The CPAP recall from Philips is a national and international catastrophe, but also a chance that therapy with oral appliances will finally be recognized for its effectiveness,” says Thomas B. Girvan, DMD, FACP, director of the dental laboratory at the VHA Office of Dentistry. “My sleep medicine colleagues, especially those who have already accepted oral appliance therapy, are asking for our intervention to help their patients through this chaos.”

Daniel Medrano, CEO of Medrano & Associates LLC, which manages primary care and endocrinology clinics for medical devices and reimbursable assessments for people with diabetes, said, “MyTAP is the fastest solution for patients, healthcare providers, manufacturers and DME companies working on it to keep and keep their customers from recalling. The myTAP can be used on patients with a history of snoring and it can change their lives just as mine personally did. My life as CEO is better with this simple, FDA-cleared medical device, and I’m sure other people can benefit from myTAP too. ”Medrano points out that even after Philips finally corrects a patient’s CPAP, patients may still find a value in your myTAP. “The myTAP is a good solution for Philips CPAP recall, and it is also a great solution for patients who may have CPAP and want to carry a small and portable device that may also be reimbursable with HCPCS E0485” , he says.

Typical handling of a myTAP by Airway Management ([email protected]) is a maximum of 5 working days, including shipping. “The myTAP is domestically manufactured and we have a large inventory and can ramp up production if necessary,” said Charles Collins, CEO of Airway Management.

It is also available through Patterson Dental and Great Lakes for clinicians who wish to have the equipment in stock. For physicians looking to refer their patients, myTAP is available through Apria Direct, Sunset Healthcare, and Airway Management’s network of established medical and dental offices. Airway also works with the Department of Defense and VA to supply the TAPTM sleep care system portfolio through their distribution network. Kaiser Permanente has also been treating non-adherent CPAP patients with myTAP for years. Kaiser Permanente’s San Bernadino County Sleep Center director Dennis Hwang, MD said, “We strongly believe that oral appliance therapy can be excellent therapy for select patients, and I believe it will with time will grow. “

myTAP is incredibly easy to customize and titrate. It fits most teeth and bites. Every half turn of the dial advances 1/3 mm. Optional vertical washers that increase vertical openings by 3, 6 and 9 mm are also available. “Due to its design and innovative approach to patient fitting, myTAP will perform better than any other oral device on the market. As with any therapy, there are no solutions for everyone … However, no other non-custom-made device fits so precisely or adapts so gradually. If a patient cannot be treated with a myTAP, then probably no other oral device would work, ”says Collins.

The adjustment takes less than 20 minutes and is best supervised by a professional, which can be done via telemedicine. “There have been a lot of patients who have also made themselves fit,” says Collins. “The same goes for titration. It is designed in such a way that it can be easily and gradually adjusted so that the patient can find his ideal position. “

The myTAP was originally intended as a test device before switching to a custom TAP device. “We have learned over time that it can be used as a long-term device because of its ease of use, lower cost and, in many cases, better patient outcomes,” says Collins. Each device comes with a 30-day patient compliance guarantee program and a 90-day warranty against product defects.

myTAP with face mask

Sleep specialist and surgeon Ofer Jacobowitz, MD, PhD, FAASM, says, “In contrast to PAP, oral appliances are of course not effective in all OSA patients and would therefore be effective for a subset of patients.” He performs a fiber optic endoscopy in the practice in order to assess the coupling of the mandibular advancement to the movement / dilation of the pharynx walls in order to assess a possible effectiveness.

Jacobowitz says: “The thermoplastic myTAP appliance is light, thin, easy to install and has great potential for further development. It can be a good alternative for patients with stable dental and oral health who cannot now use a PAP machine. Since it is inexpensive, it can be delivered to the office relatively inexpensively (time and office space use). It can be as effective as a custom appliance as long as the retention (fit) is good as the mechanism is the same as it is mandibular advancement. Ideally, it should be adjusted by an ENT or dental sleep expert to improve the result. “

The myTAP design is based on the TAP custom appliance, which has over 40 independently researched studies.

These include:

  • An Army study (N = 497) with TAP had patients with an average pretreatment of 30 (severe), while after treatment it was 8.3, practically the same as for CPAP.
  • A myTAP pilot study was carried out at the Woolcock Institute by Grunstein et at and shows that 82% (9/11) of the patients had either a 50% reduction in AHI or an AHI <10.
  • The guidelines of the AASM (American Academy of Sleep Medicine) and AADSM (American Academy of Dental Sleep Medicine) name TAP as the leader among oral appliances that use both oral appliances and CPAP criteria.

In addition, a full study on myTAP is being carried out with ACTA in Holland. The initial results show slightly better results compared to a TAP Custom. “This is likely due to thinner trays, variable verticals, and mouth guards,” says Collins.

The suggested retail price for myTAP is $ 200 for the device alone plus an optional customization fee. “It was successfully covered with E0485 (PDAC) resulting in coverage of $ 130 to $ 800. There is potential to improve on this as demand from consumers and professionals increases, ”says Collins.

Patrick Holbrook, Creative Director of Sunset Healthcare, said, “The myTAP device has been clinically proven to provide the same day treatment for mild to moderate sleep apnea and is an immediate solution for patients in need of therapy but due to the ongoing Philips recall . This is an innovative cash product that can also work well as a last resort for non-compliant patients. “

Collins concludes, “Airway Management wants to be part of the solution for the millions of patients affected by this recall. With myTAP – a proven, professional medical product – we can do this immediately. “

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Airway management

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