ELEVATE Study Aims to Improve Selection Criteria and Outcomes for Patients with Severe Emphysema Treated with the PneumRx™ Endobronchial Coil System

Professor Felix Herth, Head of the Department of Internal Medicine, Pulmonology and Critical Care Medicine, at Thoraxklinik at Heidelberg University Hospital, explains: "ELEVATE continues to build on the body of clinical evidence for Bronchoscopy Lung Volume Reduction (BLVR) with Coils. It will answer open questions and is designed to confirm patient selection criteria for emphysema dominant patients. As the Principal Investigator of ELEVATE, I am very positive about this study, it will help to advance the therapy for the treatment of severe emphysema to the next level."

Patients with severe emphysema might be eligible for the study. If you are interested in learning more about this study, please see the study description on clinicaltrials.gov NCS 03360396.

About PneumRx™ Endobronchial Coils 

The PneumRx™ Endobronchial Coils are minimally invasive medical implants designed for the treatment of severe emphysema with hyperinflation.

The shape-memory nitinol Coils are indicated for use in patients with homogeneous and/or heterogeneous severe emphysema to improve quality of life, lung function, and exercise capacity.

The PneumRx™ Endobronchial Coil System is used in conjunction with a 2.8mm working channel therapeutic bronchoscope and fluoroscopic imaging to introduce multiple Coils into the lungs using a minimally invasive approach that requires no incision. When implanted in sub-segmental airways of the lung, each nitinol Coil is designed to: gather and compress damaged lung tissue, re-tension the airway network, reduce airway collapse and air trapping, and redirect air to healthier portions of the lung

About Published Trials 

Three randomised controlled trials document the clinical benefits of the PneumRx™ Endobronchial Coil System with an acceptable safety profile.

Published clinical data is available concerning the treatment of severe emphysema with PneumRx™ Endobronchial Coils. Three randomised controlled trials (RCTs) with up to 12 months follow-up and a total of more than 450 patients document a positive effect and acceptable safety profile.^[1]-[3] In these three RCTs (RESET^[1], REVOLENS^[3] and RENEW^[2]) quality of life, lung function and exercise capacity were improved to a statistically significant degree by BLVR with Coils. In all three trials, the primary endpoint was met and improvement was noted in all other recorded parameters.

The patients' quality of life score improved by more than twice the Minimal Clinically Important Difference (MCID) in all three trials^[4]. In the opinion of experts, positive changes in the St. George's Respiratory Questionnaire (SGRQ) score reflect the decrease in breathlessness in daily life. The FEV1₁values increased after BLVR with Coils in comparison to control patients, while lung RV decreased.

In addition to the RCTs, PneumRx, a BTG International group company, has conducted several open label studies and supported post-hoc analyses of the published data.

About BTG 

BTG is a global healthcare company focused on Interventional Medicine. Our innovative medical technology helps physicians treat their patients through minimally invasive procedures. We have a growing portfolio of products that advance the treatment of cancer, vascular conditions and severe emphysema. BTG's Pharmaceuticals business provides products that help patients overexposed to certain medications or toxins. To learn more about BTG, please visit: btgplc.com.

For further information contact:
BTG
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
+44-20-7575-1595; Mobile: +44-7773-251-178

FTI Consulting
Ben Atwell/Simon Conway
+44-(0)-20-3727-1000

References
^[1] Shah PL et al. Lancet Respir Med 2013;1:233-240.
^[2] Sciurba FC et al. JAMA 2016;315:2178-2189.
^[3] Deslee G et al. JAMA 2016;315:175-184.
^[4] Jones PW et al. Eur Respir J 2002;19:398-404

SOURCE BTG plc