Sanovas Gets FDA OK for its PulmoVia Working Channel

Sanovas Inc. has received 510(k) clearance from the U.S. Food and Drug Administration to market its PulmoVia Working Channel.

The PulmoVia is one of several tools in the platform of patented technologies Sanovas is developing to improve diagnostic and therapeutic interventions in the lung.

“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,” said Larry Gerrans, chairman, president and CEO of the San Rafael, Calif.-based firm. “It is an important part of our re-imagination of the technologies required to improve diagnostic and therapeutic treatments in the lungs.”

Traditional bronchoscopes incorporate small-diameter operating channels into large-diameter optical assemblies. This combination of devices has limited the size, quantity and capabilities of the tools the clinician can effectively pass through these small diameter operating channels to diagnose and treat the lungs, according to Sanovas officials.

The large optical and steering components of traditional bronchoscopes compromise the available size left for the working channel, thus restricting the size of complementary endoscopic accessories, such as biopsy forceps, that may be passed through them. These traditionally small channels also restrict flow, hampering attempts to irrigate and suction the lungs of critical care patients with heavy bronchial secretions and clots.

The PulmoVia de-couples the operating channel from the optical assembly to transform the current paradigm, thereby enabling the delivery of a large-diameter operating channel via a small-diameter optic. This advance can effectively double the amount of space within the operating channel, without increasing the geometric footprint of the device, the company claims, which maximizes the size, quantity and capabilities of the tools the clinician can use to diagnose and treat the lungs.

The PulmoVia Working Channel was designed so that clinicians can use much larger instruments to obtain tissue samples, retrieve foreign bodies, and initiate therapies while keeping their critical care patients breathing easily. In addition, since PulmoVia is a single-patient-use disposable device, procedure costs are minimized while staff is freed from the burdens of reprocessing.

“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,” said Gerrans. “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.”