Sanovas said last week that it won FDA 510(k) clearance for its PulmoVia working channel, part of its platform designed to improve diagnostic and therapeutic interventions in the lung.
Working channels are normally integrated into bronchoscopes with optics as 1 piece, but the PulmoVia working channel is separate, CEO Larry Gerrans told MassDevice.com.
“We took a look at the paradigm of bronchial intervention and found it was limited by the spatial constraints of the items itself, and we wanted to evolve the whole process,” Gerrans said.
PulmoVia has a larger diameter than standard working channels, which allows a greater variety of sizes and types of tools that can be used through the channel during procedures, he said.
“We believe the PulmoVia is a breakthrough solution that evolves the longstanding limitations of lung intervention associated with traditional bronchoscopes and bronchoscopic interventions, in general. It is an important part of our re-imagination of the technologies required to improve diagnostic and therapeutic treatments in the lungs,” Gerrans said in a press release.
The device is the 1st of Sanovas tools to receive approval, said Gerrans. Sanovas is pursuing approval of optics that work with the PulmoVia, as well as the platform of other instruments the company is developing, he added.
“Our product vision is designed to give doctors the ability to perform faster, more effective therapies while enhancing patient safety through a single-use, disposable design. PulmoVia will enable the rapid deployment of multiple instruments into the airways. It will also enable quick, inexpensive, highly effective airway clearance for patients in critical care environments where they can experience heavy pulmonary secretions that impair their ability to breathe,” Gerrans said.
