From rxpgnews.com
PAS Port Proximal Anastomosis Device Fails to Meet Efficacy Standards
By FDA advisory committe
Apr 26, 2005, 06:45
Cardica�s 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, FDA�s 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 don�t think that the standard was actually met,� he acknowledged.
�The reason may not be that the device isn�t 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 Cardica�s 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 FDA�s 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, Cardica�s 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 Cardica�s 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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