AffloVest Portable Airway Clearance Device Enhances Treatment Mobility And Comfort For CF and COPD Patients

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by Charles Moore |

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Austin-based International Biophysics Corporation’s marquee product, AffloVest, is a cutting-edge technology airway clearance vest that represents a major advance in treatment of respiratory diseases such as Cystic Fibrosis (CF), Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, and similar related ailments. This High Frequency Chest Wall Oscillation (HFCWO) vest that gives respiratory patients new freedom to move around during treatments. German-engineered and already widely adopted in Europe, AffloVest is marketed in the United States by International Biophysics Corporation.

schultzkHFCWO refers to rapid oscillation of the patient’s chest wall to promote a more productive cough in the patient. HFCWO has been demonstrated to effectively promote the mobilization of bronchopulomary secretions over a control group. A March, 2013 clinical randomized efficacy study and conducted by Dr. Konrad Schultz, Chief Physician at the Bad Reichenhall Clinic in Munich, Germany, investigated usage benefit of the AffloVest as an HFCWO treatment device. The researchers found that prior to introduction of the AffloVest, and with just the implementation of the patient’s existing pulmonary regimen of care, 48.5% of patients studied had relatively fluid bronchial secretions (landing somewhere between 0-2 on the scale) while 51.5% of the patients had much thicker bronchial secretions (falling between 3-5 on the scale). Additionally, only 42.5% of patients were able to cough productively (again, scoring between 0-2) while 57.5% had relatively less productive coughs or a near inability to cough at all (scaled between 3-5).

These figures demonstrate that the active comparator treatment already being implemented at the clinic was somewhat effective in just under half of the patients receiving care. However, after introduction of the AffloVest and the implementation of High Frequency Chest Wall Oscillation (HFCWO) to the care regimen of the patients, 75% of patients had relatively fluid bronchial secretions (landing somewhere between 0-2 on the scale) and only 25% of the patients had thicker bronchial secretions (falling between 3-5 on the scale). Similarly, 75% of patients found they were able to cough more productively (scaled 0-2) after the Afflovest treatments, and only 25% had less productive coughs.

The study abstract notes that statistics of those scoring in the 3-5 range can be additionally examined to determine if there was still improvement in condition, and that prior to introduction of HFCWO to their regimens, a full 76% of patients who rated their secretions as thicker scored a 4 or 5 on the scale (5 being the thickest). After the introduction of HFCWO, the percentage of patients in the 3-5 range that rated their secretions as either a 4 or 5 dropped to just 40%, and 57% those scoring in the 3-5 range in cough productivity (5 being the most unproductive of coughs) prior to the introduction of the AffloVest and HFCWO therapy scored their coughs as a 4 or 5. After the introduction of the AffloVest and HFCWO therapy, this percentage dropped to just 50% of patients, demonstrating improvement in cough productivity even in the most severe of cases.

Dr. Schultz’s study concluded that: “With every single patient, a dramatic improvement in cough productivity and bronchial secretion viscosity was observed in combination with the pulmonary regimen of care. It became fundamentally easier for the patients to cough out mucus, because of the more fluid secretions and more productive cough provided by the introduction of High Frequency Chest Wall Oscillation treatment with the AffloVest.”

There are nearly 25,000 people in the U.S. with Cystic Fibrosis and currently more than 10 million diagnosed with COPD, according to the Centers for Disease Control. Heretofore, airway clearance vests have tethered the patient by an air hose to bulky machines, which require direct electrical current. AffloVest on the other hand, features built-in oscillating modules, and is claimed to be the first-ever portable, battery-operated HFCWO vest, enabling users move about freely during treatments, or if they prefer, to sit comfortably in almost any environment. Users can go for a walk outside, move around the house, or relax in front of the television as the therapy proceeds.

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The patient slips the vest on, buckles three clips on the front of the vest, tightens the straps to ensure a secure fit, and then, depending on individual treatment needs, chooses one of nine possible settings using a handheld control attached to the right side of the vest. A rechargeable battery pack with several hours of charge life fixed to the right side of the vest provides the required power for mobile treatments. The AffloVest also includes an A/C to D/C power adapter that allows the vest to be powered indefinitely from wall current should longer treatment periods be required or a charged battery unit is not available for use. When fully charged, the battery has the capacity for more than six treatments at maximum intensity. Treatment times can vary depending on physician prescription, however they generally take 20-30 minutes and are conducted twice daily.

afflovestcontrollerAffloVest, which is available in five sizes (XS, S, M, L, XL) to serve both children and adults with chronic lung conditions, and weighs in at approximately 5 to 10 pounds, is the lightest and quietest device of its kind on the market today, and unlike certain other respiratory vest options, AffloVest provides adjustable levels of treatment intensity with  three distinct modes of oscillation treatment (Drainage, Vibration, Percussion), and utilizing all three therapies in a treatment session enhances successful airway clearance. Another major benefit of the AffloVest is the patient will notice that the AffloVest does not deliver as harsh a treatment to their bodies as older technologies, yet patients find the AffloVest delivers an equivalent treatment.

Doctors and patients can accordingly tailor their treatments to their needs, with settings that provide chest wall oscillation treatment on both front and back of the vest. Three adjustable intensity levels (Soft, Medium, Intense) and nine total setting variations let patients choose their own level of treatment. The AffloVest’s frequency ranges from 5Hz to 20 Hz. The intensity levels dictate the frequency which generally runs at 5 Hz for the lowest setting, 13 Hz for the medium setting and 20 Hz for the highest setting. AffloVest is also quiet during operation.

Because of AffloVest’s unique integral module system, the treatment does not vary with the patient’s position, and can be administered while the patient is sitting, standing, or laying down (a feature that will be especially appreciated by patients with ALS or Muscular Dystrophy.) Being easy to store and easy to carry, AffloVest is a particularly ideal solution for respiratory patients who travel.

Last fall, AffloVest was approved for Medicare and private health insurance reimbursement, earning FDA 510k market clearance in the United States and private health insurance reimbursement under the Healthcare Common Procedure Coding System (HCPCS) code E0483 – “High Frequency Chest Wall Oscillation,” thereby opening the door for Americans with respiratory disease to benefit from the vest’s new technology and greater comfort during treatments.

afflovestFront“With both Medicare and private health insurance reimbursement approved for AffloVest, this breakthrough technology is affordably available to millions of patients now,” says International Biophysics Corporation President David Shockley in a release. “Other airway clearance vests tether the patient by an air hose to bulky machines that must be plugged into a wall. The AffloVest is the market’s first portable, battery-operated HFCWO vest. Users can move about freely even travel during treatments, or sit comfortably in almost any environment, in any position, even while lying down.”

AffloVest requires a prescription from a physician and is now available to U.S. patients through Durable Medical Equipment (DME) and Home Medical Equipment (HME) retailers.

For a video demonstration, visit:
https://www.afflovest.com/about-afflovest/how-to-use-the-afflovest/

For more information, visit:
https://www.afflovest.com/

Sources:
International Biophysics Corporation
Klinik Bad Reichenhall

Image Credits:
International Biophysics Corporation
Klinik Bad Reichenhall