From rxpgnews.com
PAS Port Proximal Anastomosis Device Fails to Meet Efficacy Standards
By FDA advisory committe,
Apr 26, 2005 - 6:44:38 AM
Cardicas PAS Port proximal anastomosis device has appeal as a technology for less invasive coronary bypass surgery, but the firm lacks sufficient data to demonstrate safety and effectiveness, FDAs Circulatory System Devices Panel members agreed April 22.
I find this a very attractive device, and I think the data are very promising they all go in the right direction, panelist Jeffrey Borer, MD, Weill Medical Center, observed.
Nevertheless, there is an efficacy standard that was set, and, according to the way I would look at the data which is relatively conservatively I dont think that the standard was actually met, he acknowledged.
The reason may not be that the device isnt very good, but that the numbers were very small and there is ambiguity around the edges, Borer argued. As a result, it is hard for me to draw a firm conclusion that this device has met the efficacy standard that was stated.
Cardica presented two pivotal studies supporting a 510(k) for PAS Port: a 55-patient prospective single arm trial, and a 54-patient cohort from a trial originally intended to evaluate Cardicas C-Port distal anastomotic connector.
The cohort was compiled retrospectively from a subset of patients in the trial who had received PAS Port at the discretion of the surgeon.
Both trials were performed in Europe and did not undergo FDAs investigational device exemption process.
FDA recommends that 510(k)s for coronary bypass anastomosis devices show that at least 80% of grafts remain patent in a trial powered so that the lower limit of the confidence interval be 95%. Patency is defined as less than 50% stenosis after six months.
However, Cardicas 109-patient pooled data was not powered to show 80% success within the 95% confidence interval. Among the 99 patients that completed follow-up, 91% of the bypass grafts implanted with PAS Port remained patent.
According to Wolf Sapirstein, MD, moreover, the lower confidence boundary for Cardicas study result is only 84%.
The agency established the performance criteria for coronary bypass anastomosis devices after consulting with the panel at a meeting last March.
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