Austin, Texas-based International Biophysics Corp. (IBC), the developer and manufacturer of the AffloVest airway clearance device for people with pulmonary disorders, recently published a new article titled “Lung function improvement with AffloVest HFCWO use: a clinician’s perspective on PFT score data from 12 patients with cystic fibrosis” on its website.
The pulmonary disorders for which AffloVest is used include cystic fibrosis (CF),
chronic obstructive pulmonary disease (COPD), bronchiectasis, chronic bronchitis, and other conditions that can cause respiratory impairment.
Twelve patients using AffloVest for periods ranging from less than a month to almost a full year experienced increases in Pulmonary Function Test (PFT) scores based on measurements taken before and after treatment with the AffloVest. Lung function measurements like the average forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and forced expiratory flow 25–75 percent (FEF 25-75 percent) increased 15.22 percent, 17.41 percent, and 11.21 percent, respectively, with the AffloVest.
Patient PFT data used as a resource were collected by Michelle W. Tackett, RRT, and Vivian P. Henderson, RRT, both registered respiratory therapists at East Tennessee Children’s Hospital in Lake City, Tennessee.
“This new data demonstrates once again the improved pulmonary outcomes seen with AffloVest use in patients with severe respiratory conditions,” said H. David Shockley Jr., CEO of International Biophysics, in a press release.
Weighing about 10 pounds, AffloVest is a portable, battery-powered, high frequency chest wall oscillation (HFCWO) vest that promotes airway clearance and lung secretion mobilization, and gives respiratory patients new freedom to move around during treatments. German-engineered and already widely adopted in Europe, AffloVest is made and marketed in the U.S. by IBC.
HFCWO refers to rapid oscillation of the patient’s chest wall, using pneumatic energy to promote a more productive cough in the patient. HFCWO has been demonstrated to effectively promote the mobilization of bronchopulmonary secretions over a control group.
A March 2013 clinical randomized efficacy study commissioned by IBC and conducted by Dr. Konrad Schultz, chief physician at the Bad Reichenhall Clinic in Munich, Germany, investigated the benefit of AffloVest as an HFCWO treatment device. The researchers found that before AffloVest, and with just the implementation of the patient’s existing pulmonary and orthopedic regimen of care, 48.5 percent of the patients analyzed had relatively fluid bronchial secretions (landing between 0-2 on the scale), while 51.5 percent of the patients had much thicker bronchial secretions (3-5 on the scale). Additionally, only 42.5 percent of patients were able to cough productively (again, scoring between 0-2), while 57.5 percent had relatively less productive coughs or a near inability to cough at all (scaled between 3-5).
An independent study by Michael Cooper, a registered respiratory therapist in Chicago, Illinois, found breathing score improvements in a case study of five adolescents with cystic fibrosis comparing the AffloVest to an air-bladder vest.
The 2015 study, “An Evidence-based Study of Adolescents with Cystic Fibrosis Demonstrated that AffloVest by International Biophysics Contributed to Improved Lung Function Scores,” reported lung function values using FEV1 (which measures the forced expiratory volume in one second) in patients before and after AffloVest therapy. There are several devices and variables that improve lung function scores, but normally they are lower than 10 percent, a suboptimal value. Cooper observed 11.5 percent improvements in the group.
This latest article reconfirms patient lung function improvement with a different set of patients in a different part of the country. The data in all three articles demonstrate that patients can have better outcomes when using AffloVest.
AffloVest’s recent FDA 510k clearance means the airway vest is now available in the U.S. by prescription to patients diagnosed with certain respiratory diseases and other related ailments. AffloVest is approved for Medicare and private health insurance reimbursement.
“International Biophysics continues to focus on bringing innovative, disruptive medical devices and technologies to market that improve treatment therapies and patient outcomes,” Shockley said. “We are very happy to know that our technology is helping patients benefit from improvement in their lung function. We expect to see increased clinician adoption of AffloVest technology in their patient’s airway clearance therapy.”
For more information, visit http://www.afflovest.com.