InterVapor System Used for 1st Time in China After Device’s Approval
A group of chronic obstructive pulmonary disease (COPD) patients in China has undergone surgery using Broncus Medical’s InterVapor system — the device’s first use in the country since its approval by Chinese regulators earlier this year — the company announced in a press release.
These first surgeries using the system were led by clinicians at Xi’an International Medical Center Hospital and Shenzhen Hospital at the University of Chinese Academy of Science.
“This marked the official entry of InterVapor into the clinical commercialization phase in China,” Broncus Medical stated.
China’s National Medical Products Administration (NMPA) approved the InterVapor system in March. In addition, the device has been approved for use in Germany, Italy, Switzerland, and the U.K.
InterVapor also was named a breakthrough device by the U.S. Food and Drug Administration (FDA) in 2019, a designation that aims to speed up the development and regulatory review of medical devices.
The system is designed to be used in a procedure called bronchoscopic thermal vapor ablation, or BTVA, which is a form of lung volume reduction. In simple terms, this kind of treatment aims to prevent air from going to parts of the lungs that are heavily diseased, allowing for healthier parts of the lungs to take in more air. In BTVA, diseased parts of the lungs are destroyed using very hot water vapor (steam).
Clinical testing of the InterVapor system
A clinical trial called STEP-UP (NCT01719263) evaluated BTVA in adults with severe emphysema, a form of COPD, that mainly affected the upper lobes of their lungs. The study was funded by Uptake Medical Corp, which developed the InterVapor system; Uptake was acquired by Broncus in 2016.
STEP-UP included a total of 69 participants, ages 45–75, at 13 sites across Europe and Australia. Two-thirds of the patients were randomly assigned to undergo BTVA, while the remaining third received standard-of-care treatment and served as controls.
The study’s main goals were to assess the impact of BTVA on forced expiratory volume in one second (FEV1) — a measure of lung function based on how much air a person can forcibly exhale in one second — and on the St George’s Respiratory Questionnaire (SGRQ-C), a measure of health-related life quality.
After six months, FEV1 scores were significantly higher — by 14.7% — in patients given BTVA compared with controls, indicating an improvement in lung function. SGRQ-C scores also improved by 9.7 points in patients who underwent BTVA. Similar improvements in both measures were seen at one year.
The most common adverse event reported in the trial was COPD worsening, which occurred in 24% of patients treated with BTVA and in 4% of the controls. One of these episodes resulted in a patient’s death about three months after treatment; this was judged to be possibly related to BTVA.
According to Broncus, there are more than 100 million COPD patients in China. The survival rate for those with advanced COPD is less than 20%.
“This method of treatment significantly improves the quality of life and lung function of patients and their exercise tolerance while preserving more healthy lung tissues,” the company stated.
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