A Medical Device Daily

FDA has published the final edit of its draft guidance on PMA supplements, the first draft of which came out in March 2007, and while the agency offers some tweaks to the previous edition, the guidance nonetheless omits some details sought by industry.

The 29-page document notes that among the requests the agency received after publication of the first draft is that FDA provide "a detailed flowchart that would identify the type of supplement to be submitted" for any proposed alteration of or addition to a PMA. The agency acknowledged the "general desire ... for such a detailed flowchart," but concluded that "the complexity and variability of class III devices makes it unfeasible to develop such a flowchart."

Regarding definitions for specific regulatory terms, FDA essentially hewed to the same explanation for declining to offer definitions for terms such as "significant change" to devices or "substantial clinical data." That latter term is among several that would determine whether a new PMA is needed for changes made to an existing PMA device.

The guidance also states that the agency has opted not to deal with 30-day supplements "in part because we have not identified cases for which this provision can be effectively applied."

The guidance reiterates the agency's standing position that any modification to a PMA device would trigger a need for a new PMA filing if "you need to conduct both new pre-clinical and new clinical testing" to establish safety and efficacy. As an example, the guidance gives the case of a "transmyocardial revascularization holmium laser" designed to deal with angina that has not responded to drug treatment.

In this instance, a redesign of the device to work via percutaneous introduction into the body and a new approach of lasing the inside of the ventricular wall rather than the external surface of the ventricular wall would probably mandate a new PMA. However, some of the other discussions in the guidance address less obvious situations.

Labeling continues to be an issue for the device industry, but FDA's preference for how to deal with such changes appears to have changed little, if at all. According to the guidance, the panel track supplement continues to be the preferred mode for a new indication for a device that has not undergone significant modification when new clinical data are required to back the safety/efficacy claim, but the agency noted that it "also consider[s] a panel-track supplement to be the most appropriate supplement" for "a change to or removal of a contraindication."

FDA also notes that the guidance does not deal with a supplemental filing for a change of site for the device's manufacture. According to the guidance, sponsors will have to contact the agency "to discuss what information should be provided."

OIG allows a gainsharing contract

Gainsharing has not exactly grabbed headlines of late, but the Office of Inspector General (OIG) at the Department of Health and Human Services still routinely reviews gainsharing proposals. In a decision memo posted Dec. 8, the Office indicated it has no explicit problem with an arrangement between a hospital and one radiology and four cardiology practices.

The memo, which is dated Nov. 25, addresses an arrangement for devices and supplies used during cardiac catheterization procedures. The product standardization element of the agreement would standardize the use of stents, angioplasty balloons, guidewires and catheters and other devices and supplies. According to OIG, the hospital first established that the devices and supplies were safe and effective and "appropriate on the basis of clinical criteria. Only thereafter did the requestors consider cost," OIG notes.

Two other categories of devices and supplies are involved. The first of these are vasculature closure devices and cutting balloons, which would be limited to "an as-needed basis," and contrast agents and anti-thrombosis drugs. The agreement stipulates that physicians "still had available the same selection of devices and supplies after implementation" of the agreement as before, and each of the physician groups enjoyed a half share of the resulting savings.

The hospital's analysis of the products' usage indicated that while physicians were using a "diagnostic vascular closure device" for 88% of the relevant procedures, the level of usage could be trimmed to 37% without "adversely impact[ing] patient care."

The agreement also has a provision to restrain excess use of a procedure to increase physician fees. According to the memo, the calculation of payments to the physician groups checks to see whether the volume of a given service "exceeded the volume of like procedures payable by a federal healthcare program performed in the base year which preceded it." Any activity in excess of this number is not reimbursed for cost savings.

OIG indicated that while the arrangement may open the door to abuse, it will nonetheless not stand in the way of the arrangement.

FDA panel says 'nay' to imaging agent

The cardiovascular and renal drugs advisory committee rendered a lop-sided vote of 16-1 against approvability for a contrast agent proposed for use in cardiovascular imaging as recent reports of adverse events with other imaging agents hung overhead.

Panelists at the Dec. 10 meeting cited a lack of consistent efficacy data in the pivotal trial for Imagify (AI-700) as well as indications that the product induced low blood pressure in some patients. The product's sponsor, Acusphere (Watertown, Massachusetts), had hoped to get the product on the market as an adjunct to cardiac ultrasound for patients with angina. Imagify was seen as similar to products that rely on microbubbles as contrast agent vehicles despite relying on the use of a porous microsphere to deliver the contrast effect.

Sherri Oberg, President/CEO of Acusphere, said in a statement posted at the company web site that the firm "continue[s] to believe in Imagify for its intended purpose and will work with FDA through the completion of the review process to determine what additional information might be required for approval."