Some patients with severe emphysema may have a shot at breathing easier — a possibility many of them may have given up on because of the seriousness of their condition.

Spiration (Redmond, Washington) has now begun enrolling patients in its IBV Valve trial in the U.S. The purpose: to generate safety/effectiveness data to seek FDA approval for the treatment of severe emphysema.

“I think the reason this trial is important is because there are not a lot of options for these patients,” Gregory Sessler, executive VP and CFO for Spiration told Medical Device Daily. “Most of these patients end up on medical therapy and supplemental oxygen. Once they’ve been medicated and on oxygen, there’s not a lot [more] that these patients can elect to do.”

Sessler mentioned lung volume reduction or a lung transplant as the primary options for some patients with advanced emphysema. But such surgeries have limited eligibility because of their complexity and — in the case of lung transplants — the limited availability of the organs.

“We’re very excited about the potential for our product to fill that gap,” Sessler said.

The IBV Valve System is designed to redirect airflow from diseased portions of the lung to healthier areas. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the bronchial tubes through the mouth or nose) to deploy the small umbrella-shaped valves into the airways of the upper lobes of the lungs.

“Our goal is to block inhaled air from reaching those diseased areas and redirect the airflow to healthier portions of the lungs,” Sessler said. “The goal is to redirect the ventilation to where it can do the most good.”

Although the valves are intended to be permanent, they can be removed via a minimally invasive procedure if necessary, according to Spiration.

Rick Shea, president/CEO of Spiration, said in a statement that more than 3 million Americans are living with emphysema, a condition that is “chronic and severely impacts quality of life.”

Daniel Nader, a clinical assistant professor of internal medicine and director of the Oklahoma State University Center for Respiratory Medicine (Tulsa, Oklahoma), enrolled the first patients in the pivotal trial.

“There are currently few treatment options for people with severe emphysema, who struggle with each breath and therefore cannot do very simple things that most people take for granted, such as simultaneously walking and talking,” Nader said. “Spiration’s valve therapy – which is much less invasive than lung surgery – may one day offer a new treatment option to improve quality of life for these patients.”

The IBV Valve Trial is a prospective, randomized, blinded clinical trial that will enroll up to 500 patients at up to 40 sites in the U.S. The primary endpoints will be measured at six months. Importantly, patients enrolled in the control arm of the study will be eligible to receive treatment with the IBV Valve System after completion of the six-month study period.

Sessler said the IBV Valve Trial design is based on results of a pilot study.

“Findings of the pilot study are encouraging, and suggest that the IBV Valve may provide improvements in quality of life for many patients. We hope to confirm these results in the pivotal trial,” said Daniel Sterman, MD, director of Interventional Pulmonology at the University of Pennsylvania Medical Center (Philadelphia), who presented further results from the pilot study last week at the annual meeting of the European Respiratory Society’s (Lausanne, Switzerland) in Stockholm, Sweden.

The study is open to men and women age 40 to 74 who have been diagnosed with predominantly upper lobe emphysema and shortness of breath with exertion. Eligible patients are able to participate in pulmonary function and standardized exercise tests, have not smoked for four months and are willing to not smoke during the trial.

Emphysema, a disease in the Chronic Obstructive Pulmonary Disease (COPD) category, has no cure. For those with the disease, the tiny air sacs that make up the lungs (alveoli) are enlarged or destroyed, impairing the exchange of oxygen and carbon dioxide with the blood, reduces the lungs’ ability to exhale air, and is accompanied by coughing and breathing difficulties, initially with exertion and eventually also while at rest, Spiration noted.

The most common cause of emphysema is an inflammatory reaction to inhaled smoke. Currently available treatments for emphysema are generally palliative and include medications, home oxygen therapy, pulmonary rehabilitation, lung volume reduction surgery and lung transplantation.

Spiration’s IBV Valve System has received CE mark approval for the treatment of diseased and damaged lung. It is an investigational device in Canada.

Spiration joins at least one other company working to offer patients with severe emphysema another treatment option.

In July, Broncus Technologies (Mountain View, California) reported starting its Exhale Airway Stents for Emphysema (EASE) trial to explore an investigational procedure called airway bypass, which uses drug-eluting stents to keep the new pathways in the lung open for trapped air to escape — in other words, it involves poking needle-sized holes in the patient’s lungs. This in turn, may relieve severe emphysema symptoms such as shortness of breath, the company said (Medical Device Daily, July 5, 2007).

Spiration has raised several funding rounds, the most recent an F round of $13.4 million last year (MDD, April 4, 2006). That round was led by new Olympus Medical System (Tokyo) and included funding from Guidant (Indianapolis), New Enterprise Associates, Sprout Group (currently New Leaf Venture Partners), Versant Ventures, Three Arch Partners, InterWest Partners and Investor Growth Capital.