Thursday, April 22, 2010

Cryolife may have problems beyond continued supply of Hemostase

video
A new non-clinical video comparing Hemostase (AKA Arista) with PerClot indicates Cryolife may have problems beyond continued supply of Hemostase. The video indicates a much stronger absorptive capacity for PerClot manufactured by SMI. The non-clinical video available HERE on Youtube appears to be an internal SMI validation of their product. Meanwhile the Medafor rejected proposal and (what appears to be imminent divorce) of the Medafor-Cryolife marriage is being thrashed out publicly in a curiously tabloid fashion.
Recently Medafor CEO Gary Shope stated "we no longer believe that CryoLife can be viewed as a trustworthy partner" and on March 18, 2010 after notifying CryoLife that it was treating the EDA as terminated, Medafor notified CryoLife that it would not fulfill their order.
Gary Shope, CEO of Medafor, has also stated, "Over the past six months, CryoLife has repeatedly breached our contract in China, Europe, Brazil and the U.S. CryoLife has also continued to insist that it is entitled to distribute HemoStase in China and Japan, despite the clear terms of the EDA to the contrary . As such, we were highly concerned about whether CryoLife was going to honor our agreement in the future, and had no choice but to insist it provide us assurance, as required by law. CryoLife ignored our request, effectively repudiating the contract and allowing us to cease all performance under the agreement.” Under the agreement, CryoLife had the exclusive right to sell the MPH product into cardiac and vascular surgeries in the United States (excluding Department of Defense facilities) and into cardiac, vascular and general surgeries in the rest of the World (except China and Japan ) excluding ENT, orthopedic, neurosurgery and topical applications.
Both Cryolife and Medafor have made no secret of their mutual dissatisfaction with each other, Cryolife has created a site dedicated to public laundering of their difficulties HERE and includes the following:
Frequently Asked Questions
While Medafor respond on their website HERE



2 comments:

Anonymous said...

FYI, Arista/Hemostase is deactivated by using water. If you listen to the Video water was used, not blood. Besides I do not think Perclot has FDA approval. I would not call this a problem for Arista.

Anonymous said...

Please read more at http://www.medaforinc.com/research/pdfs/bleedtimeincision.pdf
Where it is plainly stated that Arista/Hemostase MPH "effectively absorbs water".