Sanovas files a 510(k) clearance application with the FDA for its Vas Zeppelin Smart Catheter, saying further applications are coming for its suite of pulmonary medical devices.
Sanovas said it's asked the FDA for 510(k) clearance for its Vas Zeppelin Smart Catheter, designed to diagnose and treat chronic pulmonary conditions and lung cancer.
The Sausalito, Calif.-based medical device company bills the device as "among the smallest interventional catheters," saying it's designed to "overcome the complexity and procedural risks associated with pulmonary intervention," according to a press release.
CEO Larry Gerrans told MassDevice.com that Sanovas is pursuing a 3-phase approach to getting its 6 product lines and more than 37 products through the federal watchdog agency.
"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," Gerrans told us. "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."
Phase 1, including the 1st 510(k) application, is rolling out this year, he added, with Phase 2 slated for next year and Phase 3 planned for 2015.
"We're trying to bring the high-margin disposables and the high-margin capital equipment to market now," Gerrans explained.
A push for CE Mark approval in the European Union will come once the FDA hurdle has been cleared, he said.
"Our approach is a full-frontal approach with FDA and to go CE Mark thereafter," Gerrans said, adding that Sanovas is in talks with several potential strategic investors.
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