A handheld device (PAS-Port, Cardica) that can create an anastomosis
between a vein graft and the aorta during CABG surgery, without
conventional sutures or the need for arterial clamping, has gained
market approval from the FDA, its manufacturer announced today [1].

Approval was granted based on the strength of a prospective,
randomized 220-patient trial that compared anastomoses made with the
device with conventional hand-sewn anastomoses, according to
Cardica. "Results showed that the study met its primary end point of
noninferiority," it said in a press release.

"The PAS-Port system is associated with significant patient benefits
compared with hand-sewn anastomoses," according to the trial's
principal investigator, Dr John Puskas (Emory University, Atlanta,
GA), as quoted in the company statement. "Because the PAS-Port
device can be used to create a proximal anastomosis without needing
to clamp the aorta, it may ultimately improve patient outcomes by
shortening surgery times and hospital stays and reducing
complications associated with aortic clamping."

In April 2005, an FDA advisory panel declined to recommend approval
of the PAS-Port system based on data then available. Although
members of the panel expressed enthusiasm for the device, heartwire
reported at the time, they were also unconvinced by the limited
scope of the submitted data, which were primarily from only 47
patients and supplemented by what seemed questionable analyses based
on pooled patient populations.

The PAS-Port system has been available in Europe and Japan for
several years, the company noted, and in the latter country "is used
today in more than 20% of all proximal anastomoses performed using a
vein bypass graft during CABG surgeries."


Cardica. Cardica Receives 510(k) clearance to market PAS-Port
proximal anastomosis system for use in cardiac bypass surgery [press
release]. September 9, 2008. Available at: http://phx.corporate-
ir.net/phoenix.zhtml?c=195013&p=irol-
newsArticle&ID=1194942&highlight=.