PneumRx® Coils included in new global clinical guidelines and given positive recommendation to treat severe emphysema patients in France
December 05, 2016
Note: Links to GOLDCOPD.org will open in a separate web browser tab, leaving the PneumRx BTG website.
London, UK, 5 December 2016: BTG plc (LSE: BTG), the global specialist healthcare company, today announces the inclusion of treatment with lung coils in guidelines for the management of chronic obstructive pulmonary disease (COPD) published by the Global Initiative for Chronic Obstructive Lung Disease (GOLD). At the same time, the French Ministry of Health has published its positive recommendations regarding PneumRx® Coils on its website.
The updated GOLD guidelines now include endobronchial lung coils as a minimally invasive, bronchoscopic approach to reducing hyperinflation in severe emphysema patients. This update includes coils as a therapy option for emphysema predominant patients with severe hyperinflation, regardless of disease distribution or presence of collateral ventilation.
The French Ministry of Health published its positive recommendations regarding PneumRx® Coils on its website as meeting an unmet medical need and fulfilling a public health interest based on therapeutic improvement over optimal medical therapy. This assessment will be a critical component in determining national reimbursement for treatment of patients with severe emphysema in France.
Both the GOLD recommendations and determination by the French Ministry of Health are based on two multicenter randomized controlled trials that examined the use of PneumRx® Coils compared to usual care in changes in quality of life, lung function and exercise capacity in patients with advanced homogeneous and heterogeneous emphysema.
Guenter R. Janhofer, BTG Chief Medical Officer, commented: “We’re pleased that both GOLD and the French Ministry of Health have acknowledged the value of PneumRx® Coils for emphysema patients. In both randomized, controlled, multi-center studies, patients treated with the PneumRx® Coil experienced improvements in quality of life, lung function, and exercise capacity. Data and imaging analysis is ongoing to further consider best practices for patient selection. This analysis will be shared in upcoming publications to provide additional treatment considerations to physicians.”
The GOLD report supports healthcare professionals worldwide to implement effective COPD management programs based on quality of evidence. The 2017 GOLD Report is the fourth major revision of GOLD, incorporating an update of evidence reviewed by the global scientific committee and a comprehensive reassessment of prior recommendations for the diagnosis, assessment, and treatment of COPD. For details visit: www.goldcopd.org.
The PneumRx® Coil is a shape-memory nitinol coil implanted in the sub-segmental airways of the lung in patients with severe emphysema via a minimally invasive bronchoscopic procedure. For more information visit: www.pneumrx.com.
In Europe the PneumRx® Coil has received CE Mark Certification. The endobronchial coil is currently limited to investigational use only in the US. BTG is finalizing the regulatory submission to the FDA for approval of endobronchial coils in the US.
For further information contact:
Andy Burrows, VP, Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605
Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536
Chris Sampson, Corporate Communications Director
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178
Note: Two changes were made from the English Press Release. The changes align the product description more clearly with the GOLD guidelines and clarify that the PneumRx® Coil has received CE Mark Certification
BTG is a global specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of cancer, severe emphysema, severe blood clots and varicose veins, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today’s most complex healthcare challenges. To learn more about BTG, please visit: www.btgplc.com.