PercuSurge’s GuardWire Distal Protection System Backed by FDA

The Circulatory Devices Advisory Committee to the US Food and Drug Administration (FDA) on Monday recommended 510(k) clearance of PercuSurge’s GuardWire Plus Temporary Occlusion & Aspiration System for use during coronary revascularization procedures to treat saphenous vein graft (SVG) disease.

PercuSurge’s distal protection system is intended to prevent the embolic materials that were blocking the blood vessel from flowing downstream into the veins, which can expose the patient to the risk of heart attack or death.

At a meeting in Gaithersburg, Maryland, the panel unanimously agreed that the benefits of the new system outweigh its risks.

However, members qualified their endorsement with certain conditions. For example, they agreed that labeling should stress the need for specific training before the device is used.

The panel asked the company for assurance that it would not sell the GuardWire to cardiac centers that had not established appropriate training systems.

PercuSurge’s SVG Angioplasty Free of Emboli Randomized Study (SAFER) involved 800 patients at 68 sites and was designed to compare treatment with the GuardWire system to standard SVG therapy, or an “unprotected” stent procedure.

The study demonstrated a 50% reduction in the major adverse cardiac events normally associated with revascularization, including death, Q-wave or non-Q-wave myocardial infarction, emergent bypass surgery, or repeat target vessel revascularization.

Although the study was not powered to show reduction in patient mortality rates, significantly fewer deaths occurred in patients treated with the GuardWire system, panelist Dr. Michael Domanski noted.

The FDA is likely to follow its panel’s advice and clear the device for marketing, but whether the GuardWire system will become the new gold standard remains unclear.

PercuSurge representative Deborah Hinman noted that the system represents an “entirely new treatment category” and argued that, on the strength of the SAFER data, it should be considered the new distal protection system benchmark.

Hinman urged the panel to recommend that sponsors testing new devices be required to randomize their products against the GuardWire system.

Dr. Gregg Stone of the New York City-based Cardiac Research Institute backed the plan, asserting that, given the favorable SAFER study results, randomization against unprotected SVG patients is “no longer ethical.”

However, Julie Broderick, vice president of clinical and regulatory affairs at Kensey Nash Corporation, based in Exton, Pennsylvania, said that sponsors should be allowed “flexibility and creativity” in designing their trials.

Broderick noted that the GuardWire’s level of acceptance among cardiologists remains to be seen and that some investigators may be hesitant to use it as a control device in the meantime, making it harder for sponsors to get timely trials underway.

While most committee members agreed that a randomized design is important for distal protection systems, they noted that an appropriate comparator is not easily defined since the standard of care will differ center to center as more systems are marketed.

About half of coronary bypass patients develop SVG within 10 years after their operations.

To correct the problem, patients must undergo revascularization through a second bypass operation or via stent or balloon catheterization. Percutaneous catheterization procedures are favored over repeat bypass due to their significantly lower mortality rates.

Repeat bypasses carry a higher mortality and morbidity rate than the initial procedure, noted FDA medical devices official Dr. Bram Zuckerman.