Spiration, a developer of medical devices designed to benefit patients with acute and chronic conditions of the lung, has received humanitarian device exemption approval from the FDA for the use of its minimally invasive IBV Valve System to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged, following lobectomy, segmentectomy, or lung volume reduction surgery.
This FDA approval represents the first for a bronchial valve implant for the lungs. The FDA humanitarian device exemption (HDE) approval of the IBV valve system is based on results from 58 patients enrolled in a US investigational device exemption (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. The effectiveness of the device for this use has not been demonstrated.
Rick Shea, president and CEO of Spiration, said: “This FDA approval, the first for a lung device in recent memory and the first ever for a bronchial valve, is an exciting milestone and marks an advancement toward broader FDA approval of devices to treat various types of lung conditions. As one of only three HDE approvals so far in 2008, this approval is a significant accomplishment for Spiration.”
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