AffloVest for Lung Disease Receives CE Mark, Approval in Canada, Australia, New Zealand
International Biophysics Corporation recently received CE Mark, Health Canada, and Australian TGA approval for AffloVest, allowing the company to sell and market the vest in Canada, Australia and New Zealand, and in countries using the CE mark.
The AffloVest is a portable high frequency chest wall oscillation (HFCWO) vest that promotes airway clearance and lung secretion mobilization for patients with certain respiratory diseases that include cystic fibrosis (CF).
Oscillating therapy works to clear mucus and pathogens from the lungs of CF patients, helping to lower the risk of infections and inflammation. The AffloVest, unlike other HFCWO devices, uses oscillating motors rather than air bladders to free secretions in patients’ lungs.
David Shockley, Jr., International Biophysics’ CEO said in a press release called the approvals an exciting achievement.
The CE Mark alone certifies that the product meets European Union health, safety, and environmental requirements to ensure customer safety. Effectively, products with the CE Mark can be sold in 32 counties in the EU.
“We are very happy to now be able to provide this innovative technology to patients in our neighboring Canada, as well as Australia, New Zealand and the rest of the world. We have also completed expanding our internal salesforce to now allow us nationwide sales and product support coverage here in the USA,” Shockley said.
The company manufactures the vests at the biophysic’s facility in Austin, Texas.
“This innovative product is now “Made in the USA”. This internal on-shore manufacturing will add permanent manufacturing and engineering jobs here, and increase our ability to remain competitive globally while meeting the growing customer demand for the AffloVest both here and internationally,” Shockley said.
The newly designed AffloVest, is an upgrade of the previous model. It now boasts a longer battery life, an electronic digital programmable controller with compliance monitoring, better overall tailored fit, a “more stylish” denim color, and more sizes.
The company also now offers AffloVest Pro, a special disposable infection control enhanced hospital version, that offers health professionals greater oscillation airway clearance therapy control to target specific lungs regions.
Data from a previous 25-patient trial using AffloVest for 78 days, reported that the device led to improvements in pulmonary function test (PFT) scores in 12 CF patients. The data showed a 15.22% improvement in average FVC (forced vital capacity), a 17.41% improvement in FEV1 (forced expiratory volume in 1 second), and an 11.21% improvement in FEF 25-75% (forced expiratory flow 25–75%), all measures of lung function.
The remaining 13 CF patients did not show significant increases in lung function, but also suffered no lung function decline.
Results from a study conducted in 2015 with five patients showed that treatment with AffloVest contributed to improved lung function scores compared to air bladder technology scores. Specifically, the data showed a 9.5% improvement in average FVC, 11.5% improvement in FEV1, and 21.3% improvement in FEF 25-75%.
“The AffloVest technology is affecting lives for the better. The proof is in the data,” Shockley said.