The myTAPTM is available within days, fit in less than 20 minutes, and validated by the most independent research studies in the market.
Paid for by Airway Management Inc
The recall of millions of Philips-manufactured CPAPs, bilevels, and ventilators has upended the lives of obstructive sleep apnea patients. Since the recall announcement last month, patients have been anxiously seeking solutions, particularly since Philips has not disclosed its timetable for when the impacted devices will be repaired or replaced.
So for the indefinite future, sleep professionals are searching for therapies that are available immediately. Oral appliances are a well-known CPAP alternative—but some are not well-validated in independent research studies or are cost-prohibitive or difficult to order, making them risky for some physicians to prescribe. But there is an accessible, thoroughly researched, and affordable oral appliance that can treat your patients’ sleep apnea within a week after the order is placed: Airway Management, Inc’s myTAP.
“The Philips CPAP recall is a national and international disaster but also an opportunity for oral appliance therapy to finally be recognized for what it so effectively brings to the table,” says Thomas B. Girvan, DMD, FACP, director of dental laboratory operations at the VHA Office of Dentistry. “My sleep physician colleagues, especially those who already embraced oral appliance therapy, are requesting our intervention to help their patients through this mess.”
Daniel Medrano, CEO of Medrano & Associates LLC, which manages primary care and endocrinology clinics for medical devices and reimbursable assessments for people living with diabetes, says, “The myTAP is the fastest solution for patients, medical providers, manufacturers, and DME companies who are working to sustain and retain their customers from the recall. The myTAP can be used for patients who have a history of snoring, and it can change their lives like it did mine personally. My life as a CEO is better due to this simple FDA-cleared medical device, and I’m sure that there are other people whose lives can benefit from the myTAP as well.” Medrano notes that even after a patient’s CPAP is ultimately fixed by Philips, patients may still find value in their myTAP. “The myTAP is a good solution for the Philips CPAP recall, and it is also a great solution for patients who may have a CPAP and want to carry a small and portable device that may also be reimbursable with HCPCS E0485,” he says.
Typical turnaround of a myTAP through Airway Management ([email protected]) is a maximum of 5 business days, inclusive of shipping. “The myTAP is manufactured domestically and we have ample inventory and can ramp up production, as necessary,” says Charles Collins, CEO of Airway Management.
It is also available through Patterson Dental and Great Lakes for clinicians who want to stock the devices. For clinicians who want to refer their patients, myTAP is available through Apria Direct, Sunset Healthcare, and Airway Management’s network of established medical and dental practices. Airway also partners with U.S. Department of Defense and VA supplying the TAPTM Sleep Care System portfolio through their distribution network. What’s more, for years Kaiser Permanente has treated nonadherent CPAP patients with myTAP. Director of Kaiser Permanente’s San Bernadino County Sleep Center, Dennis Hwang, MD, says, “We are big believers that oral appliance therapy can be an excellent therapy for select patients, and my feeling is that it will grow over time.”
myTAP is incredibly simple to fit and titrate. It fits most dentitions and bites. Each half turn of the dial advances 1/3 mm. Optional vertical shims that increase vertical openings by 3, 6, and 9 mm are also available. “myTAP will work better than any oral appliance on the market due to its design and innovative approach in fitting patients. As with any therapy there are no solutions for all…However, no other non-custom appliance fits so precisely or adjusts so incrementally. If a patient cannot be treated with a myTAP, then it is likely no other oral appliance would work,” Collins says.
Fitting takes less than 20 minutes and is best overseen by a professional, which can be done via telemedicine. “There have been many patients who have fit themselves too,” Collins says. “The same goes with titration. It is designed to be easily and incrementally adjusted for the patient to find their ideal position.”
The myTAP was initially intended as a trial device before moving into a custom TAP device. “What we have learned over time is it can be used as a long-term device due to its ease of use, lower costs, and in many cases a better treatment outcome for patients,” Collins says. Each device comes with a 30-day patient compliance guarantee program and a 90-day warranty for any product defects.
Sleep specialist and surgeon Ofer Jacobowitz, MD, PhD, FAASM, says, “Oral appliances, of course, are not efficacious for all OSA patients, unlike PAP, and thus would be effective for a subset of patients.” He performs fiberoptic endoscopy in the office to assess for coupling of the mandibular advancement to the movement/dilation of the pharyngeal walls to assess for possible effectiveness.
Jacobowitz says, “The myTAP thermoplastic appliance is light, thin, easy to fit and has a large advancement capability. It can be a good alternative option for patients with stable dental and oral health who are now unable to use a PAP device. Since it is low cost, it can be delivered in the office relatively inexpensively (time and office space use). It can be as effective as a custom-made appliance, as long as retention (the fit) is good, as the mechanism is the same, being mandibular advancement. Ideally it should be fitted by an ENT or dental sleep expert to improve outcome.”
The myTAP design is based on the TAP Custom appliance, which has over 40 independently researched studies.
These include:
- An Army study (N=497) using TAP had patients with an average pre-treatment of 30 (severe) while post-treatment it was 8.3, virtually the same as CPAP.
- A myTAP pilot trial was conducted at the Woolcock Institute by Grunstein et at shows that 82% (9/11) of patients had either a 50% reduction in AHI or AHI <10.
- AASM (American Academy of Sleep Medicine) and AADSM (American Academy of Dental Sleep Medicine) guidelines cite TAP as leading among oral appliances using both oral appliance and CPAP criteria.
Additionally, a full study on myTAP is underway with ACTA in Holland. Initial outcomes show slightly better outcomes versus a TAP Custom. “This is likely due to thinner trays, variable vertical, and mouth shield,” Collins says.
Suggested retail price of myTAP is $200 for the device alone, plus an optional fitting fee. “It has been successfully covered with E0485 (PDAC) resulting in coverage from $130-$800. There is potential to improve this with increased consumer and professional demand,” Collins says.
Patrick Holbrook, creative director of Sunset Healthcare, says, “The myTAP appliance is clinically proven to allow same-day treatment of mild to moderate sleep apnea and is an immediate solution for patients who need therapy but can’t access a CPAP machine due to the ongoing Philips recall. This is an innovative cash product that can also work well as a last resort option for noncompliant patients.”
Collins concludes, “Airway Management wants to be part of the solution for the millions of patients affected by this recall. We can do this immediately with myTAP—a proven, professional medical device.”
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