Temple Lung Center director helps FDA approve medical device

The Spiration Valve System helps alleviate the symptoms of patients diagnosed with a chronic lung disease.


UPDATE at 12:17 a.m. on Feb. 15, 2019

The average person takes more than 23,000 breaths a day and most don’t have to think twice about it. 

That’s why Dr. Gerard Criner, the director of the Temple Lung Center, dedicated 30 years to researching chronic obstructive pulmonary diseases, like the incurable lung disease emphysema. Gerard Criner has now helped develop the Spiration Valve System, an umbrella-shaped device that is a new treatment option for people with emphysema.

The device is inserted into airways to the lung, to block airflow to damaged lung tissue, allowing healthy tissue to function more efficiently. Criner helped the device gain approval from the U.S. Food and Drug Administration through his work as lead investigator in the clinical trial.

Gerard Criner, a 1979 medical school alumnus, said the SVS improves quality of life for patients by reducing shortness of breath and making them more self-sufficient and socially engaged. 

“It could increase their ability to do their activities of daily living,” Gerard Criner added.

About 3.4 million Americans had been diagnosed with emphysema as of 2017, according to the Centers for Disease Control and Prevention. Emphysema is a chronic disease that damages the air sacs in the lungs, making it difficult to breathe, according to Mayo Clinic. Prescription drugs like steroids and antibiotics can be combined with therapy like breathing exercises to manage the condition.

“These people have a very severe disease,” Criner said. “They have lung function that is on average 28 percent of normal. They’re severely limited and they have few other options to improve their care.”

The FDA approved the SVS in December, about a year after the completion of the device’s four-year clinical trial, titled EMPROVE. The trial took place in the Temple Lung Center and 30 other hospitals, medical centers, universities and clinics across the United States and Canada.

Olympus, an international company that manufactures medical systems including surgical devices, built the SVS for FDA approval. 

Criner helped plan the clinical trial and co-authored the results of the trial in the European Respiratory Journal, which were published by the European Respiratory Society. Helga Criner, a research nurse coordinator on the trial who is married to Gerard Criner, said Olympus asked her husband to be one of the physicians representing the company for FDA approval of the device. 

“I just hope that there will be more studies and more treatments and more devices that can be approved for patients with emphysema because that is very limited right now,” Helga Criner said. “The hard thing is when they fail the study or if [the patients] don’t qualify, you feel very bad for the patient because they look very desperate.”

Participants were evaluated before and after treatment for various symptoms, like the volume of air they could forcibly breathe out, hyperinflation of the lung and shortness of breath. 

The SVS has been in the works for nearly 20 years. Greg Sessler, the president and CEO of Spiration, Inc., a medical device manufacturing company owned by Olympus, said Spiration came up with the idea for the valve while actively pursuing emphysema treatment options.

Spiration teamed up with Olympus, which manufactures bronchoscopes that are used to implant the valve in a minimally invasive way. For some emphysema patients, the SVS may offer relief comparable to that provided by lung volume reduction surgery, a procedure that cuts out damaged parts of the lung so healthy tissue takes over and better functions, according to the Mayo Clinic.

The SVS could offer an alternative to the high-risk surgery, Sessler said. 

The FDA designated the SVS as a breakthrough medical device and is approved for use in the United States, European Union, Australia and New Zealand.

“It’s very exciting times for treating conditions like this [and] for Dr. Criner and for the institutions like Temple, which have focused on these patients for quite a period of time, and is recognized as one of the leading hospitals in the U.S., that understand this disease and keeps developing options for treating these patients,” Sessler said.

Helga Criner has seen firsthand how the SVS treatments have improved the lives of patients with emphysema, she said.

“When they talk about their [emphysema], they’re so debilitated,” she said. “And now that they have the valves and they’re able to kind of do the things they weren’t able to do…it’s nice. It gives you gratification that you can help them in some way.”

CORRECTION: A previous version of this story misstated the amount of hospitals included in the clinical trial. There were 30 hospitals that were a part of the trial.

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