The US Food and Drug Administration has rejected healthcare firm BTG’s Elevair endobronchial coil system to treat severe emphysema.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Elevair is a trademark of PneumRx, a BTG International group.
The FDA has rejected PneumRx’s premarket Approval (PMA) application for the endobronchial coil system to treat of people with severe emphysema.
In June this year, the FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee has voted against the approval of the Elevair system.
Elevair endobronchial coil system has been developed to provide a minimally invasive approach to lung volume reduction with the support of novel technology.
By using a minimally invasive and bronchoscopic technique, the endobronchial coil system will place nitinol shape-memory coils into the lungs as a treatment for severe emphysema.
The Elevair system procedure is a bilateral treatment, which targets the most damaged lobe in each lung. It will be performed in two separate sessions within one to three months.
Elevair coils will reduce hyperinflation and lung volume by compressing the most damaged tissue and restoring lung elastic recoil.
The Elevair system is comprised of two main components, including the coil and delivery system.
The company has designed the delivery system to work through standard bronchoscope with 2.8mm diameter working channel. The nitinol coils will serve as permanent implants.
Elevair system, branded as the RePneu coil system outside the US, secured CE mark approval in 2010. It is commercially available in selected countries inside and outside of Europe.
BTG, which is mainly focuses on interventional medicine, is engaged in the development of products for the treatment of cancer, vascular conditions and severe emphysema.
The company’s interventional oncology products will be used in minimally invasive procedures for the treatment or providing symptomatic relief for people with cancer and benign tumours.
Its bead products block arteries (embolisation), which feed liver and other hypervascularised tumours, depriving them of blood and nutrients.
The firm’s radiotherapy product includes millions of small glass microspheres, which deliver radiation directly to liver tumours.