VascuCel is due to launch on November 1st. I have been doing a bit of digging into the competition and have found some interesting information into Vascu-Guard by Baxter International. They have had multiple issues, a recall, recent FDA warnings, potential deaths and possible law suits. It appears that they are in some trouble with this Vascular product. While I don't want to see patients have a problem with any products it does seem our entry into this market is being timed to perfection.
Initial recall:
http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm449592.htm
Latest FDA warning Sept 16
http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm518852.htm
FDA letter to health practitioners:
http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm518804.htm
Potential legal action:
http://www.gtbslaw.com/blog/
http://www.rxinjuryhelp.com/news/20...in-string-of-issues-for-baxter-international/
It is also really interesting to note that Vascu-Guard is cross linked with Glutaraldehyde which in my view will cause problems for all products that use it due to its toxic nature. Another point of note is the comparative difficulties in surgical preparation before use compared to VascuCel. The notes below our line this information:
I am excited by the long term prospects for our new product VascuCel and the fact that we can fold it into our existing sales team offerings and target established accounts and customers leveraging off existing strong relationships. All of this without increasing staff costs.
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