Cardica at Wedbush 2013 Life Sciences Management Access Conference
An audio recording of this may be found on company's website. The first part is a rehash of company and product information heard on other CCs and investor talks. The remainder centered on the just completed European trials of the Microcutter Xchange 30. Aimed at demonstrating non-inferiority of the stapling system to the FDA, analysis of trial data seems to show at least that, and the company will file a 510K with the FDA this week.
Previously, one concern I had was that while the trial was progressing Cardica was altering the form of the stapler. It seemed to me like a moving target for FDA evaluators. This was addressed near the end the Q&A session. Evidently, for the FDA, the staples constitute a Class 2 device and the stapler, a Class 3. What could not change during the trial were the staples and they were the same, beginning to end. Dr. Hausen stated the FDA not only allows, but expects and encourages improvements in the stapler part of the system based on feedback.
Buzzy. Thanks for the the info. Keep in mind the efficacy of the staple depends not only on it's design but also the delivery system (stapling device). The final shape of the staple is a manifest of the initial staple and the deformation it goes through via the driver and anvil mechanism. If it is true that final fired staple geometry is the cause of effective hemostasis and if it is true that final staple geometery is the net result of initial shape, material condition and firing mechanism then would it not also be true that a change in the delivery mechanism could result in a change in the effectiveness of the fired staple? Now the changes made to the device were stated by Hausen to be ergonomic in nature... addressing user interface issues. This change most likely would not have an effect on staple formation. However I noticed in some of their device renderings that they now have a design that fires proximal to distal rather than distal to proximal. This would be a very significant change. I'm not sure when this change occurred as they have not been very transparent on these types of topics. They have also mentioned the incorporation of I beam technology over the past year which if completed would also represent a change that could change staple formation.