Although air leaks are somewhat common after various kinds of lung surgery, prolonged air leaks – when the tissue just won't heal after more than a week – make it difficult for patients to breathe, require additional surgery and longer hospital stays. Cements and other tissue-healing therapies have not been consistently effective.

The FDA has just issued a Humanitarian Device Exemption (HDE) to Spiration (Redmond, Washington) for its IBV Valve System, designed specifically to address this complication.

While the HDE is focused on a patient population of about 4,000, indications for the implanted valve will likely broaden significantly following the return of more positive data, potentially eliminating long hospital stays – and related sky-high costs – for thousands of patients.

"People have tried to develop glues and different patching mechanisms, but they have been mostly ineffective," Spiration President/CEO Rick Shea told Medical Device Daily. "It's a very unique approach. All of the other mechanisms for treating air leaks have been interoperative. This is more of a precaution at the time of surgery. Post-surgery the options are quite limited."

This HDE, which is specifically for patients who have lobectomy, segmentectomy or lung volume reduction surgery, represents the first for a bronchial valve implant for the lungs.

Shea said the procedure is relatively simple, one that most chest surgeons can perform with a minimal amount of training. The umbrella-shaped valve is inserted through a bronchoscope and placed in the area affected by the leak.

Once implanted, the valve allows air to flow in only one direction. It remains in the patient for six weeks at which time another simple procedure is performed to remove the implant via a bronchoscope.

"This valve may ease post-operative recovery of patients undergoing certain kinds of lung surgery," Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health, said in a special statement about the HDE. "This approval is an example of the agency's commitment to addressing unmet medical needs through the HDE program."

Approval of the IBV Valve System is based on results from 58 patients enrolled in a U.S. IDE study of the device for the treatment of emphysema and four patients treated with the IBV Valve System for prolonged air leaks under IDE compassionate use exemptions. But the effectiveness of the device for this use has not been demonstrated yet in lobectomy, segmentectomy or lung volume reduction surgery.

In Europe, the system already has received CE-mark clearance for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of air leaks. (MDD, Oct. 9, 2008).

Spiration granted Olympus (Tokyo) and its distributors exclusive marketing and distribution rights for the IBV Valve System in 43 European countries, including the UK and other countries belonging to the European Union, representing what it said is the broadest distribution arrangement for a bronchoscopic treatment for emphysema in Europe.

Shea said the efforts to obtain HDE approval have been just as difficult as any full-blown premarket approval application (PMA) for an implantable device.

"You have to have solid safety data," he said, adding that the company's experience in Europe and data in treating emphysema patients yielded that needed safety data. "We're now halfway through our emphysema study. This time next year that study should be completed.

"There are clearly a bunch of other indications for the valve," Shea said. "Over time, we would like to be able to help a broader group of patients."

Spiration is a privately held company backed by a group of investors, including Three Arch Partners, New Enterprise Associates, Versant Ventures, New Leaf Ventures (Sprout Group), InterWest Partners, Investor Growth Capital, Saints Capital and Olympus.

Shea said a price has not yet been set for the valve implant, but that reimbursement "plays no role. The patient is already in the hospital and has already been treated for a condition and now there's a complication. Now you have to address the complication. The hospital is presumably going to pay because they are anxious to discharge the patient."