j grossman

Medical Device Company Hansen Medical Files for IPO

My understanding is that only animal data has been submitted to the FDA and that the robotic sheath is big (about 5 mm in diameter) and relatively stiff according to doctors that have inspected the prototype at the recent Boston Heart conference. As a result, safety and effectiveness remain concerns and the FDA actions reflect such concerns. My guess is not the product will not meet with success unless human clinical data is provided and cleared by the FDA for safety and effectiveness review, especially for the more complex and value added procedures. Seems to me that the company would have been better off waiting for FDA clearance instead of having to explain FDA objections in the open. The S-1 is well worth reviewing.