System to improve microinvasive lung surgeries heads for FDA clearance
Using what it claims is the world’s smallest surgical camera, a company that’s been working for over a decade on technology to lower the risk and improve the outcome of surgeries for respiratory diseases like COPD and lung cancer could be ready to commercialize as early as January.
Sanovas Inc. has a technology portfolio that it says can improve the treatment of lung diseases by allowing surgeons to better access, image, measure and diagnose anatomy in small airways and vessels.
The company has just secured its first patent and is moving through the 510(k) process. CEO Larry Gerrans anticipates the first of the technology will be approved and commercialized by January.The Vas Zeppelin Clear Vessel Technology platform is a complex system with many pieces and parts that can be seen here. Notable among them is imaging technology that enables surgeons to see through blood and opaque fluid and is smaller than those used today, leaving a larger channel for surgeons to operate.
“A lot of the disease is being found in the periphery, where the diameter is 3 or 2 or 1 mm,” Gerrans said.
Small, steerable catheters allow access to these areas, and components like microsensors that measure oxygen pressure and map blood flow at a tumor site help surgeons understand the environment they’re operating in, Gerrans said. The system will also help surgeons remove unwanted biological materials in hard-to-reach body cavities, he said.
COPD, a condition marked by airflow obstruction, is thought to affect 16 million people in the U.S. alone, and lung cancer is the leading cancer killer in the U.S. Although One of the Sanovas’ main goals is to create technology that makes surgeries for these conditions easier, less risky and accessible to the masses, as pulmonary disease also occurs at high rates in countries like China, Britain, and India.
It’s been a slow and steady crawl for the California-based company, which has been developing this technology for more than 10 years. Part of that, Gerrans said, has been seeking clinical validation for the system from 250 pulmonary surgeons from all over the world.
In addition to improving surgery, the system is also intended to provide a standard way to access the lungs, as a springboard for future innovations.
“If you look back to 90s when laparoscopic technology was emerging as new technologies, the companies that did well were the ones that provided tools to image and access the anatomy, like Stryker and U.S. Surgical (now part of Covidien),” Gerrans said. “The first thing we recognized was that there is going to be a tremendous amount of innovation in the pulmonary space and that we are going to provide the next-generation of imaging and accessing technologies so that we will have the right tools to perform the procedures the right way.”