Emphysema Device Completes IDE Trial Early

Interventional pulmonology company PneumRx, Inc., says it has completed enrollment in its RENEW Study, nearly 3 months ahead of schedule. The RENEW Clinical Study is the FDA-approved IDE pivotal trial for the PneumRx RePneu Coil System, a treatment for severe emphysema.

Background

The RePneu Coil is a minimally invasive device intended to improve exercise capacity, lung function, and quality of life for severe emphysema patients. The implant, a memory shape coil inserted in multiples into diseased lung tissue, is designed to compress poorly functioning tissue, increase elastic recoil in the lung, and re-tension the diseased airway network, relieving breathlessness and allowing patients to perform more activities of daily living.

The RePneu Coil is CE Marked and has been used in Europe for the treatment of emphysema since 2008. The Coil treatment has proven to be effective for a broad range of emphysema patients and adoption of the technique in routine clinical practice is rapidly expanding throughout major emphysema treatment centers across Europe. A key advantage of the Coil is its simple mechanical design which is highly adaptive and has proven effective in treating patients with heterogeneous as well as homogeneous emphysema, and in upper and lower lobes. The RePneu Coil works independently of collateral ventilation, a common condition in emphysema patients which precludes patients from treatment with other types of implants.

See how it works in this video

It was anticipated that the study, which began enrolling subjects in the US in February 2013, would take until the end of 2014 to enroll 315 patients. Instead, enrollment was completed nearly 3 months early, with over 70 subjects enrolling in the month of September alone. PneumRx no doubt judges this rapid enrollment rate as demonstration of the need for its system.

Investigator comments

“The patient interest in this trial has been overwhelming,” said Dr. Charlie Strange of MUSC, Principal Investigator for the study. “Such a quick enrollment was possible only because of a large commitment of all of the study teams involved in the treatment of severe COPD patients. The RePneu Coil represents a true therapeutic breakthrough in the treatment of patients with severe emphysema, and is the only option for the majority of these patients with homogenous disease. We look forward to being able to offer the RePneu Coil treatment for all severe emphysema patients in the near future.”

Company comments

“We are thrilled to have completed enrollment in our pivotal trial, bringing us one step closer to PMA approval. PneumRx is eager to bring this ground-breaking technology to the United States,” said Erin McGurk, PneumRx’s President and CEO. “It has been so gratifying to support the hard work of our clinical trial sites and witness the excitement of our U.S. principal investigators who have been able to offer the RePneu Coil treatment to their patients. We look forward to submitting the pivotal trial results in support of a PMA application to sell the RePneu Coil System in the United States.”

Source: PneumRx, Inc., Business Wire

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