FAQ

Frequently Asked Questions
Regarding Diaphragm Pacing

FAQ

Frequently Asked
Questions

The Avery Diaphragm Pacemaker is the only diaphragm pacemaker with full FDA Approval and CE Marking Privileges for adult and pediatric use.  

Please see frequent questions about the device below.  If you have additional questions not addressed here, or would like additional information about the device, please fill out our contact form by clicking “request more info” below and our team will reach out.  

Patient Eligibility & Active Life

We offer virtual presentations for healthcare providers and patients. Your physician can refer you to an implantation center experienced in phrenic nerve pacing.

For the latest details or personalized advice, visit averybiomedical.com or speak with a representative. Contact Avery Biomedical Devices directly via phone or email for a consultation.

The Avery Diaphragm Pacemaker (Phrenic Nerve Stimulator) is indicated for adult and pediatric patients who require chronic ventilatory support due to upper motor neuron respiratory muscle paralysis (RMP) or central alveolar hypoventilation (CAH). These patients often have:
           – High spinal cord injuries (C1-C3)
           – Central hypoventilation syndrome (CCHS)
           – Central sleep apnea
           – Diaphragm paralysis from surgery, trauma, or viral infection.
The device is suited for patients with functional phrenic nerves, lungs, and diaphragm muscles.

NO: In cases of patients who had been on ventilator support for prolonged periods, diaphragm disuse atrophy is still reversible and patients can be successfully weaned. However, conditioning of the diaphragm could take longer to achieve 24-hour pacing. In 1978, Glenn reported one case of a patient who was mechanically ventilated for 11 years and was able to successfully pace with PNS. 35 There are three known Spinal Cord Injury cases located in the Avery Biomedical company database of long term mechanical ventilator dependent patients who were successfully weaned from the ventilator. One patient was dependent for 7 years, one for 14 years and one for 16 years. All three are currently pacing for 24 hours a day.

Yes, the Avery Diaphragm Pacemaker is water-resistant. Patients can safely participate in activities such as swimming, bathing, and other aquatic exercises, allowing them greater freedom and mobility in their daily lives. 

Absolutely. Users of the system participate in activities like skiing, dancing, horseback riding, watersports, and hiking. The system is designed to allow for an active and healthy lifestyle.

YES: Artificial breathing mimicking the natural method of negative inspiratory pressure leads to a lower incidence of respiratory infections (RI) than positive pressure MV. The RI per 100 days of PNS patients has been shown to be significantly lower than that of MV patients. 34 Information supplied in 2018 by the National Spinal Cord Injury Statistical Center in Spinal Cord Injury Facts and Figures at a Glance states respiratory tract infections are a major cause of mortality in SCI patients and despite reductions in mortality in many other areas for SCI patients, there has only been a slight decrease in incidence of RI caused deaths over the past 40 years. It appears that since PNS has been shown to significantly reduce RI in MV patients, PNS may be an underutilized treatment.

Surgery, Support, & Training

The Avery system can be implanted using a cervical or thoracic approach (VATS, robotic, thoracotomy). The thoracoscopic technique generally requires fewer incisions than other systems, but the approach depends on the patient and surgeon. Implantation is a surgical procedure, typically performed under general anesthesia, lasting 1-3 hours per side. Common approaches include:
             -Cervical (neck): Minimally invasive for patients over 2 years old; ideal for avoiding chest incisions.
             -Thoracoscopic (VATS): Video-assisted through small chest incisions for precise electrode placement on the phrenic nerve. Electrodes are sutured to the phrenic nerves (one or both sides), connected to subcutaneous receivers. Intraoperative testing confirms nerve stimulation. Full pacing usually begins 4-6 weeks post-surgery after healing. Over 2,000 systems have been implanted worldwide in more than 40 countries.

NO: It has been said that it is better to implant the phrenic nerve stimulator close to the diaphragm as in the VATS or the laparoscopic technique.31 It takes an average of 7.5 ms for an impulse applied to the phrenic nerve in the neck to travel the average adult nerve length of 27 cm.32,33 Reducing the time it takes for the applied stimulation to the nerve to induce the diaphragm movement makes no difference to the ability of the diaphragm to pace at the required rate.

ABD provides on-site support for each surgery. The Avery Diaphragm Pacemaker can be implanted via the cervical or thoracic approach, depending on patient needs and surgeon preference. No formal training or specialized tools are required for hospital staff.

On the day of surgery, the ABD representative will assist in testing the equipment in the operating room. The rep will provide hands-on support to the surgical team.

There are Centers of Excellence around the world staffed with experienced pulmonologists and surgeons who specialize in the Avery system. Contact ABD to locate a center or surgeon near you.

Yes, ABD offers both on-site and virtual in-service training for hospital staff leading up to surgery. ABD’s team will work with hospitals to ensure all staff are properly trained, and they will also be physically present in the operating room on the day of surgery to provide hands-on assistance and test the equipment.

NO: Since the early days of PNS there is no evidence that one surgical approach put the nerve at any greater risk than the other approaches. Indeed, since the nerve is stationary at that location during the surgery, there should be less risk to the nerve being surgically injured during cervical implantation. Misconceptions regarding nerve injury via the cervical route of implantation are gradually being corrected as it is understood that this complication was related to a few cases of implantation of an earlier version of the device with a bipolar cuff electrode.14 Nerve injury has not been an issue over the past 38 years with use of the monopolar device since it does not encircle the nerve.

YES: One of the reasons given for using the thoracic over the cervical approach is that the phrenic nerve may not be fully formed above the clavicle making stimulation of the diaphragm less predictable. The phrenic nerve is formed by cervical branches 3, 4 and 5 which reliably unite over the anterior scalene muscle deep to the deep cervical fascia.28 A small accessory branch is occasionally seen joining the main nerve below the clavicle.

RARELY: Cases of ipsilateral shoulder or arm pain or movement have occasionally been observed in some patients using the Avery or Synapse device.33 Shoulder movement with PNS using the cervical approach should be ascertained in the OR at the time of implantation, and if noted, the electrode should be repositioned further from the brachial plexus until this phenomenon is no longer noted. Shoulder pain cannot be assessed intra-operatively unless the monitored anesthesia technique is used. Occasionally, shoulder pain is noted long after implantation; this is thought to be secondary to current leakage through the wire insulation of the electrode and is eliminated with replacement of the wire.

NO: Glenn reported that in his early experience series there was a 2.6% total infection rate resulting in eventual replacement of the system. More infections were encountered using the cervical approach, which was the more common approach during the early experience. The report did not indicate whether the infections originated at the electrode or receiver site. The report did not differentiate between infection incidences associated with the Avery vs the Atrotech electrode/device. Searching the Avery data base for implants after 1985 revealed a 0.13% incidence of infection when implanted cervically vs a 0.25% incidence when implanted thoracically. The lower rate of infection with cervical and thoracic implants is likely due to reduced usage of the bipolar electrode, advances in surgical techniques and surgeons experience with the device.

RARELY: There is virtually no movement in the neck at the site of electrode placement over the anterior scalene muscle. However, electrode wires have been noted to break with repeated arm movement when the electrode wire is tunneled too close to the shoulder using the cervical technique. Wires used in the Synapse and extruding from the abdomen are susceptible to breakage or becoming snagged on external elements as well. In these cases, the affected wires and electrode may need to be replaced.

Insurance, Costs, & Regulatory Compliance

Yes, the system is covered by Medicare, most private insurance plans, and various government health programs. This coverage helps reduce out-of-pocket costs for eligible patients.

The Avery system costs less than $1,450 per year to operate, assuming annual replacement of external antennas and batteries. In contrast, mechanical ventilation costs $1,500 to $2,500 per month, excluding the risk of infections and additional hospital stays.

The Avery Diaphragm Pacemaker is fully approved by the FDA (PMA P860026) for both adults and pediatric patients and holds CE marking privileges for use in the European Union.

System Functionality

The Avery Diaphragm Pacemaker is an implantable phrenic nerve stimulator designed to provide long-term ventilatory support for patients with chronic respiratory insufficiency. It works by delivering electrical impulses to the phrenic nerves, which control the diaphragm—the primary muscle responsible for breathing. This stimulates natural diaphragm contractions, allowing inhalation, followed by relaxation for exhalation, mimicking normal breathing patterns without the need for mechanical ventilation.

The system consists of surgically implanted components (receivers and electrodes) and external ones (transmitter and antennas). The external transmitter sends radiofrequency energy through the skin to the implanted receivers. These receivers convert the energy into electrical pulses, which travel via electrodes to the phrenic nerves. This causes the diaphragm to contract and draw air into the lungs (inhalation). When the pulses stop, the diaphragm relaxes, allowing exhalation. The process repeats automatically to create rhythmic breathing.

NO: Being implanted with a PNS system does not mean that the patient can no longer use MV. Indeed, hundreds of patients with forms of central sleep apnea frequently choose to use the PNS system only at night when their central apneic episodes are more frequent. There have also been individuals who have been MVdependent for extended periods of time that are too anxious to use the PNS system at night and, therefore, return to MV at night. In other cases, where the ability to spontaneously breathe returns, the individuals may simply stop using the fully implantable Atrotech or Avery device or have the external wires removed from the Synapse device.

Yes, patients or caregivers can adjust the amplitude and respiratory rate of the transmitter for comfort and optimal ventilation. No special tools or consoles are needed to adjust.

– Power Source: Runs on 4 inexpensive AA alkaline batteries, easily replaced by the patient or caregiver—no recharging required.
– Daily Use: The external transmitter is worn with a belt or shoulder strap; antennas are placed over the implant sites.
– Monitoring: Patients receive training on adjustments and troubleshooting. Regular follow-ups with a healthcare provider are recommended to monitor thresholds and function.
– Lifespan: Components are durable; electrodes and receivers can last 10+ years, with external parts replaceable as needed.

Long-term Use

No, long-term follow-up studies have shown that diaphragm pacing does not “burn out” the phrenic nerve. The system operates well below safety limits for tissue damage and platinum dissolution, even at maximum settings.

Some patients have been pacing for over 40 years without nerve damage.

NO: There is no evidence that inducing diaphragm movement by repeatedly stimulating the phrenic nerve at the same site results in either phrenic nerve or diaphragm fatigue at the levels of stimulation currently used. 26 Between 1971 and 1981, phrenic nerve stimulation used a pulse train with frequencies between 25 and 30 Hz that was applied periodically to alternating nerves between 12 and 18 hours per day to prevent fatigue. Between 1981 and 1987, low frequencies between 7.1 and 11 Hz were implemented in 12 patients of the Yale group. 23 Other centers have used 20 Hz until today, resulting in continuous successful unilateral or bilateral stimulation for the past 35+ years with no finding of nerve/muscle fatigue.

Yes, diaphragm pacing can provide safe and effective bilateral pacing 24/7 for patients who require continuous ventilatory support.

ABD recommends initiating 7-14 days post-op. This process can be performed in any setting, including inpatient or outpatient care facilities.
            – ABD will coordinate with hospital staff and physicians to create a patient-specific pacing schedule.
            – ABD will also provide guidance on vent weaning and diaphragm conditioning.

Common temporary effects include hoarseness, hiccups, or mild discomfort during initial use. Rare risks involve infection, nerve irritation, or device migration, similar to other implants. Unlike ventilators, it avoids barotrauma or secretion issues but requires intact phrenic nerve function. Not suitable for patients with severe lung disease or bilateral phrenic nerve damage. Always discuss with a specialist.

No, getting an MRI is contraindicated with the (check manual)

Adverse Events

The Avery electrode is fully implantable and uses radiofrequency energy transmitted through intact skin to power the electrode. The competitor device has five wires protruding from the skin, necessitating ongoing wound care.

There is risk of tissue damage with the competitor device because of the high operating voltage needed. The competitor manual states “Output voltages may approach 50 volt D. C. during operation.” The low voltage needed with the Avery device has been shown to not put tissue at risk for damage (J. of Pacing and Clinical Electrophysiology 23(6) June 2002)

Intra-operative hemodynamic instability can develop with the competitor device procedure because of the carbon dioxide introduced into the abdomen. (Anesthesia Intensive Care 2010; 38:740-743).

The Avery Diaphragm Pacemaker has two independent circuits, one for each side with its own controls, powered by its own battery and with its own antenna. If one side does not pace, the other continues pacing independently. The competitor device has one circuit and one battery for the entire system. If it stops operating, or if the battery is dead, neither side paces. The competitor manual states: “It is possible that stimulation from the diaphragm pacing system could stop either due to electrode breakage, cable disconnection, or stimulator failure. If one of these happens, breathing will stop. Without prompt attention, this could result in permanent disability or death.”

The Avery Biomedical System has two implants, one for each side. Each implant has an electrode and its own anode, increasing redundancy. If one side fails, the other side continues to stimulate. The competitor device has four electrodes, but only one anode. If the anode lead wire is broken or does not make good contact, stimulation is not possible with any of the four electrodes.

The Avery Diaphragm Pacemaker is powered by 4 inexpensive 1.5 Volt AA-size alkaline batteries available in any store anywhere in the world. These batteries last > 400 hours when using factory default parameters. The competitor device is powered by a C-size 1.5 Volt alkaline battery. An expensive 3.6 Volt lithium battery can be used as an alternative. The manual states: “Replace the Alkaline battery every 96 hours of the NeuRx EPG use. This is about every 4 days if you are using NeuRx DPS full time”

Avery Diaphragm Pacemaker has controls so that parameters can be adjusted by the patient (on/off, amplitude and respiratory rate). The competitor’s pacemaker has an on/off button without any possible adjustment of parameters. The patient cannot adjust the respiratory rate or the amplitude.

The Avery Diaphragm Pacemaker requires no additional equipment to adjust the parameters. The competitor device requires an expensive Clinical Station console necessary during the surgical procedure to stimulate the diaphragm to find the best location to implant the electrodes, used by the doctor to optimize the settings for comfort and effect, and used to program the desired settings into the device. (taken from company website)

The Avery Diaphragm Pacemaker can generate a maximum stimulus current of 10 mA for each of the two implanted electrodes. Typical stimulus amplitude ranges from 1 mA to 5 mA. The competitor device can generate a maximum of 25 mA for each of the four implanted electrodes. Its minimum stimulus amplitude is 5 mA.

The Avery Diaphragm Pacemaker generates a maximum voltage of 10 V. Typical stimulus voltage ranges from 1 V to 5 V. The competitor manual states: “output voltages may approach 50 volt D.C. during operation.”

A cardiac pacemaker is not contraindicated in patients with an Avery Biomedical pacemaker. The competitor manual warning says “Do NOT use in patients with implanted electronic device (insufficient data is available, at this time, to establish safety with a cardiac pacemaker).” It also advises that “At this time, there is insufficient clinical data to determine safety in implanting patients with cardiac pacemakers, therefore, you should not be implanted with this device if you have a cardiac pacemaker or other implanted electrical device.”

Long-term pacing with the Avery Diaphragm Pacemaker has been proven to be safe. There are patients pacing for more than 40 years. The manual of the competitor device advises that “The long-term effects of electrical stimulation of the diaphragm are unknown.”

The Avery Diaphragm Pacemaker does not interfere with the heart rhythm. The manual of the competitor device states “there is a risk of cardiac arrhythmia being caused by the placement of the electrodes in the chest cavity.”

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Customer Service

The Customer Service Department is happy to assist with troubleshooting and provide technical information regarding diaphragm pacing. Our hours are 8:00 am to 4:00 pm (EST) weekdays.