Sanovas, a medical device manufacturer based in Sausalito, CA, has filed a 510(k) clearance application with the United States Food and Drug Administration for its Vas Zeppelin Smart Catheter. The device is designed to assist physicians in treating lung cancer and chronic pulmonary health conditions.
According to a statement from the company, the device is designed to reduce the complexity and procedural risks associated with surgical pulmonary intervention. Larry Gerrans, CEO of Sanovas, also added that the company is pursuing a three-pronged approach to getting more of its devices approved through the FDA.
In prepared remarks, he said: "We've got 6 product lines focused on what we call access – micro catheters to access the periphery of the lung – imaging, physiologic metrics, in vivo diagnostics, recannulation and in vivo drug delivery." He continued, "Phase 1 is to deliver the access technologies, the imaging technologies, the recannulation products and some diagnostics. Phase 2 is going to incorporate the physiologic metrics, more diagnostics and drug delivery. Phase 3 will be an expansion on the physiologic metrics, the diagnostics and drug delivery."
The first phase, which includes the initial 510(k) approval application, will start this year. The second phase of its approval plan is scheduled for 2014, and the final phase is scheduled for 2015. Once the company wins regulatory clearance with the FDA, it plans to pursue further regulatory approvals in the European Union with CE Mark clearance.